Posts Tagged regulatory

JOBS: September, 2019


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Please see some of my current opportunities below. All opportunities are for local (US based) candidates with valid work visa and require deep industry experience.  If you have an interest then please send an email (resume as an attachment) at wd under score darshana at hot mail or find me on Linkedin.

Clinical Trial Manager – San Jose, CA

Ideal experience: 8+ years experience in medical devices, ideally in neuromodulation.  Required, experience running clinical trials, and working with clinicians and medical centers.

Head of Regulatory – San Jose, CA 

Candidate must have 15+ years experience in bio/pharma industry. Experience working with biologics and taking a drug to market in the US and EU is essential.

Mechanical Engineer – San Jose, CA

The Mechanical Engineer is responsible for evaluating the current manufacturing processes and making design improvements to increase throughput, quality and reliability. This will be achieved by redesigning the current tooling and/or creating new tooling and equipment. The successful candidate will work independently and use sound judgment to deliver optimal manufacturing solutions. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

· Evaluate the current manufacturing processes /workflows and identify opportunities to realize improved product consistency and increased throughput
· Develop concepts and ideas for improving the exiting tooling as well as creating new tooling including semi-automation where applicable
· Take full ownership of tooling /fixture designs, conduct concept reviews, show proof of concept through prototyping coupled with supporting test data, coordinate with appropriate stakeholders for successful verification /validation, launch and documentation
· Create 3D models, engineering drawings and bills of materials
· Create comprehensive work instructions and manufacturing SOP’s
· Work closely with Process Engineering through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
· Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
· Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications
· Bachelor’s Degree in Mechanical, Manufacturing or related engineering fields
· 5-7 years hands-on experience in a manufacturing environment
· In-depth experience with complex mechanical /electromechanical design
· Extensive experience with precision mechanisms, pneumatics, fixtures /tooling and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
· Experience with creating engineering drawings, BOMs and product specifications
· Deep knowledge of material properties, heat treatment and surface finish
· Good understanding of DFM and lean manufacturing
· Excellent verbal, written, presentation and interpersonal skills
· Strong analytical and problem-solving skills
· Knowledge and/or hands-on experience with machine shop tools
· Deep knowledge of GD&T as well as proficiency with SolidWorks
· Prior experience with FDA regulations and ISO, cGMP, QMS standards
· Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications
· Knowledge /experience with electrical /electronics and PLC programming a big plus
· Knowledge /experience with plastic injection molding
· Experience with metal stamping, laser cutting and chemical etching
· Familiarity with cleaning and sterilization processes

Sr. Molding Engineer

Job Summary

The Sr. Molding Engineer is responsible for evaluating the current molding processes and leading the effort to increase throughput, quality and reliability. This will be achieved by redesigning the current tooling, creating new tooling /equipment as well as leveraging outside molding expertise. The successful candidate will become the resident expert in the areas of plastic injection molding and material selection. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

· Evaluate /characterize the current molding processes and identify areas of improvement while focusing on rapid manufacturing scale-up
· Work closely with the consumable engineering group and make recommendations for molding improvements such as use of alternate materials, parts consolidation, setup /process optimization etc. without compromising the design intent
· Conduct design concept reviews and present fresh ideas, new technologies and creative ways to take the current molding process to the next level
· Show proof of concept through rapid prototyping and supporting test data
· Take full ownership of all injection molding initiatives, coordinate with appropriate stakeholders from initial concepts through FAI, optimization, successful verification /validation, launch and documentation
· Work closely with Process Engineering through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
· Develop /optimize molding parameters and establish best practices in molding methodologies
· Work with external companies as needed to outsource injection molding activities and manage the vendors through all phases of the projects including user requirements, RFQ, vendor selection, concept & design followed by verification /validation
· Create comprehensive work instructions and manufacturing SOP’s
· Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications
· Bachelor’s Degree in Mechanical, Manufacturing, Plastics or related engineering fields
· 7-10 years of extensive, hands-on experience with plastic injection molding including but not limited to mold design, capability studies and process characterization /optimization
· Experience with rapid prototyping and multi-cavity plastic injection molding
· In-depth knowledge of material science /plastics properties and metrology techniques
· Experience with creating engineering drawings, BOMs and product specifications
· Good understanding of DFM and lean manufacturing
· Excellent verbal, written, presentation and interpersonal skills
· Strong analytical and problem-solving skills
· Prior experience with FDA regulations and ISO, cGMP, QMS standards
· Knowledge and/or hands-on experience with machine shop tools
· Deep knowledge of GD&T as well as proficiency with SolidWorks
· Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications
· Knowledge /experience with micro molding
· Knowledge /experience with DOE, SPC, FMEA
· Experience with metal stamping, laser cutting and chemical etching
· Familiarity with cleaning and sterilization processes

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JOBS: May, 2019


Please see some of my current opportunities below. All opportunities are for local candidates with valid work visa and require deep industry experience.  If you have an interest then please send an email (resume as an attachment) at wd underscore darshana at hot mail dot com.

Job Search Human Resources Recruitment Career ConceptRegulatory Manager – San Jose, CA
Requires 8+ years of experience in pharma, ideally experience in biologics.

Clinical Trial Manager – San Jose, CA
Ideal experience: 8+ years experience in medical devices, ideal in neuromodulation,  running clinical trials, working with clinicians and medical centers.

Clinical Trial Manager – San Jose, CA
Ideal experience – 8+ years of hands on experience in running pharma trials at manager level. Running clinical studies in biologics is a major plus.

Manufacturing Engineer – San Jose, CA
Requires 8+ years of experience in medical device manufacturing.

Director of Manufacturing Automation – San Jose, CA

This position requires a dynamic, energetic, self-driven, engineering leader with broad manufacturing engineering and automation experience & will report to VP of Manufacturing Operations. The Director of Manufacturing Automation will lead the development of fully automated manufacturing systems for all aspects of company’s disposable drug tablet manufacturing. This individual will be responsible for defining system requirements, developing proof of principle systems, developing timelines and managing budgets and providing direct oversight and management of automation suppliers as well as driving the implementation and validation of manufacturing lines. This individual will work closely with product development, manufacturing engineering and quality in order to ensure manufacturability, achievement of targets, and develop processes for optimum manufacturability.

Responsibilities: Define functional & detailed requirements & specifications for manu automation, including quality & regulatory requirements; Manage internal & external process automation programs, project schedules & budgets; Develop facility plans & specifications for manufacturing scale-up; Oversee installation & qualification of automated manu systems; Comply with USFDA cGMP regulations, (ISO), Company policies, operating procedures, processes & task assignments.

Requirements: Experience managing and leading complex cross functional projects involving, electrical, mechanical, quality aspects; Experience with mechatronics or automation engineering including machine, mechanism and fixture design; Strong problem solving and analytical skills; experience with use of statistical analysis & design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation. This position requires interface throughout all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome.  BS/MS in Mechanical, Electrical or Industrial Engineering & 15+ years’ experience managing an engineering group responsible for medical device development and manufacturing engineering with a strong history of hands-on experience is required. Also required Deep expertise in manufacturing automation for large scale manufacturing.

Director of Pilot Manufacturing – San Jose, CA

Innovative medical device company located in San Jose, CA has an immediate opening for Director of Pilot Manufacturing.  This position will report to VP of Manufacturing Operations. This low volume production line is crucial to the company’s several ongoing preclinical studies.

Duties and Responsibilities
Lead day to day operations including injection molding, aseptic processing, capsule assembly, supply chain and other related activities; Develop detailed production planning, resource allocation, equipment maintenance, operator training etc.; work closely with product development, pre-clinical & clinical groups and quality in order to ensure achievement of targets & develop manufacturing plans & detailed production schedules; Manage inventory of raw materials & injection molded components; Manage human resources in pilot manufacturing; Maintain a strong commitment to quality; Comply with U.S. Food and Drug Administration (FDA) cGMP regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.

Requirements
Strong problem solving & analytical skills; Experience with use of statistical analysis & design of experiments for product optimization and validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation; Experience working with ERP systems & Broad GMP manufacturing background with Class III medical devices. Requires BS/MS in Mechanical, Electrical or Industrial Engineering and 15+ years’ experience managing & supervising manufacturing with a strong history of hands-on experience successfully transferring new products into manufacturing & Deep technical experience with manufacturing processes, design control and quality systems. Also required, strong problem solving and analytical skills; Experience with use of statistical analysis and design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test and test implementation; Experience working with ERP systems. Also essential is proven ability to coach & develop employees & develop effective cross functional relationships. This position requires interface throughout all levels & functions of the organization.

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JOBS: August, 2018


Jobs search concept, Big red text word "Jobs" on white paper and Magnifying glass for jobs searchPlease see some of my current opportunities below. All opportunities are for local candidates with valid work visa and most require deep industry experience. Contract opportunities are posted at the bottom. If you have an interest then please send an email (resume as an attachment) at wd_darshana at hot mail dot com.  Please bookmark and keep checking here for updates on new opportunities.

Director of Assay Development – Palo Alto, CA

There is an exciting opportunity for Director of Assay Development in a VC backed startup based in Palo Alto, CA. Company is developing unique diagnostic platform to quantify salivary biomarkers for variety of diseases & physiological conditions. Candidate will work closely with electrical engineers to transform an oligonucleotide-based assay from optical measurements to electrical measurements on company’s proprietary platform & will play a key role in development of a high throughput assay for clinical R&D studies.

Qualifications: Experience in Molecular Biology, Biochemistry or related field w/ method development focus; data analysis & management skills; knowledge of oligonucleotide-based assay & application on biosensor based Field-Effect Transistor (Bio-FET) for developing in-vitro diagnostic device; Expertise in assay devt & validation methods, in design & prosecution of in vitro bio-recognition -based assays, and 3-5 years of hands-on exp in biomarker quantification using a variety of biophysical techniques.  Aptamer-related experience is advantageous.

Responsibilities: Manage team of lab researchers; Assist with data prep for analysis & reporting; Maintain lab equipment functionality; Track inventory, lab records, good lab practice (GLP) and safety; & Troubleshoot; Adapt assays to multiple platforms & optimize biosensing measurements; Validate biochemical assays & biomarker quantification; Develop & set-up biochemical & in vitro assay for high throughput platforms; Train team members; Provide technical information, experimental assay design & data analysis to team members.

Senior Scientist of Assay Application – Palo Alto, CA

There is an exciting opportunity for Senior Scientist of Assay Application, in a VC backed startup based in Palo Alto, CA. Company is developing unique diagnostic platform to quantify salivary biomarkers for variety of diseases & physiological conditions.

Qualifications: Experience in Molecular Biology, Biochemistry or related field w/ method development focus; data analysis skills; experience in protein and nucleic acid work using binding assays molecular interaction analysis (e.g. ELISA, SPR, FRET), protein microarray and surface chemistry. Aptamer-related experience is advantageous.  

Responsibilities: Assist w/ data preparation for analysis & reporting; Manage lab – inventory, records, equipment functions &  safety; Troubleshoot bench work; Assay Development, design & analysis; Work multidisciplinary team to design, develop & optimize assays & devices (optical and electrical); Adapt assays to multiple platforms & optimize biosensing measurements.; Validate biochemical assays for biomarker quantification; Facilitate technical communications between engineer and assay development teams.

Mechanical Engineer – Santa Cruz, CA

Company focusing on an array of brain computer interface devices to address a range of neurological problems has an opening for Mechanical engineer.

Head of Manufacturing Engineering – San Jose, CA

There is an exciting opportunity for Head of Manufacturing Engineering in San Jose, CA.  This is an exciting opportunity with high potential.

Responsibilities include,  implementing pilot manufacturing line, develop components & assembly manufacturing processes including materials science and selection, develop processes for injection molding, conventional & novel polymers, micro-product molding, converting &  sealing plastic films, micro-tablet compression, clean room processing & large molecule processing.

Required: BS in Engineering plus 12+ years of mechanical engineering experience in medical device industry. Any of the following, highly desired: Experience in consumer product medical device, pharmaceutical (transdermal and solid dosage), and combination product design, manufacturing process development, manufacturing equipment design and development, pharmaceutical and sterile device packaging development, 3-D metal and plastic product design, tooling design and fabrication, injection mold design and fabrication, CNC and g-code programming, production engineering management, maintenance management, manufacturing management, and project management and experience in new product launches through heritage product manufacturing.

Software Engineer – Santa Cruz, CA

Company focusing on an array of brain computer interface devices to address a range of neurological problems has an opening for SW engineer.  Embedded microprocessor experience and windows app experience is required. Highly preferred, design/coding experience for embedded systems with wearable/motor-driven devices.

CFO – San Jose, CA

There is an exciting opportunity for CFO for a company, in San Jose – CA. Found by a veteran leader the company focuses on disruptive drug delivery platform technology. 15+ years M&A and licensing deals experience in bio/pharma industry is required.

Director of Program/ Project Management – Santa Cruz, CA

There is an exciting opportunity for Director of Program/ Project Management for a company located in Santa Cruz – CA. This company is found by a veteran leader and focuses on an array of brain computer interface devices to address a range of neurological problems. Candidate is required to have 4+ years of medical device program or project management experience in electromechanical systems area.

Head of Regulatory – San Jose, CA

There is an exciting opportunity for Head of Regulatory for a company, in San Jose – CA. Candidate must have 15+ years experience in bio/pharma industry. Experience working with biologics and taking a drug to market in the US and EU is essential.

Design QA Scientist –  Pleasanton, CA.

Responsibilities: Support DQA Principal Scientists and Project teams; Review & approve documentation consistent with design control regulations; technical verification, risk; Assist DQA project team to assess completion of milestone deliverables; Assist in the review and development of high SOPs; Support audits/inspections; Other duties as requested.
Requirements: Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline, or equivalent combination of education and work-related experience.
Preferred: Job-related Professional License(s) or Certification(s) and 5 Years Development, Manufacturing and/or Quality Assurance experience under established quality regulations.

Clinical Research Associate II – California 

Responsibilities include, participate in design, planning, implementation and overall direction of clinical research projects; ensure compliance with the overall scientific study objectives;  work with international investigators and key customers as well; Travel to field sites to monitor studies; Receive general instructions; plans and prepare studies; Review study protocols, report manuscripts; Contribute technical & clinical operations expertise for these documents; Work with Data Management & Biostatistics staff on the design of documents and processes for the collection of study data from participating sites; Collect & maintain legal and regulatory documentation, as applicable; Assume responsibility for training & coordinating certification of study site personnel; Ensure accurate and complete study management/data collection and transfer to data management; Ensure site compliance with regulations and study protocol; Monitor the sites and provide technical assistance, as necessary; Assist, prepare and manages study timelines; Manage material logistics for the studies; Conduct reference material testing in-house. Organize investigator meetings, as necessary; Participate in Project Team Meetings; Keep informed of trends and developments in clinical research; Know &  effectively use the broad concepts of a particular field or speicalization to resolve problems of limited scope and complexity; Analyze alternative approaches to solve problems or devleop new perspectives & existing solutions. Bachelors degree in a scientific discipline or related field, or equivalent combination of education and work experience is required. Certificate of completion of sections 1 through 6 is required. Minimum 2-6 years of relevant clinical research experience and knowledge of regulations and guidelines is required.

Clerk – San Jose/ Santa Clara, CA

There is an opportunity for a Clerk in a biomed company, located in San Jose/ Santa Clara, CA area.

Responsibilities: Follow standard operating procedures to enter orders for high complexity clinical lab tests; Be responsible for efficient and accurate entry of customer and patient demographic data, clinical information, test request information and physician information; Review, understanding, and executing customer-specific requirements for order entry; Create service requests in CRM system to document issues and work closely with client service team to resolve and escalate incomplete or unclear order issues; Check work of others to ensure order entry quality; Troubleshoot problems & assist employees with process questions; Fax requests to customers to resolve unclear orders; Run queue reports to ensure daily tasks are completed; Assist account set up administration; Act as training resource for department employees; execute process improvement recommendations; Retrieve forms from lab; Escalate issues to appropriate internal resources; Interact with Finance team to provide patient billing information in a secure manner.

Skills: 2+ years experience working in the clinical laboratory, medical, order management, or related field; Experience using Customer Relationship Management (CRM) Software (e.g. NetSuite, Salesforce.com), laboratory information systems. Microsoft Office Suite a plus. Must be able to follow laboratory procedures and must adhere to the laboratory quality control policies; Ability to identify & act on issues within an order that may impact customer satisfaction & test turnaround time; Must be able to type 45 words per minute with excellent accuracy; Must be able to lift up to 35 lbs.

 

Regards, Darshana

4088980000

 

Contract signed and sealed, pen, stamp, documents for signature, document folder iconCONTRACT OPPORTUNITIES 

RMD Biospecimen Scientist – Pleasanton, CA — 6 mo. contract

The BioSpecimen Management (BSM) Scientist position will facilitate the daily operations associated with providing the best-in-class simple biological solutions to customers. Biospecimen solutions include acquisition, characterization, and management of biological materials, and build of select panels fit for purpose for RMD research. Responsibilities include deliver simple, efficient solutions, facilitate receipt of shipments of human biological samples, verify sample integrity and data accuracy, process (centrifuge, aliquot, and pool) samples, consolidate inventory, retrieve and distribute samples, maintain inventory of supplies and ships supplies and facilitate routine activities in the build of custom panels, in close communication with team members. Also includes, responsibility for the accuracy, quality, and timeliness of all assigned projects, tasks and related activities,  accontablity for electronic records management, use of validated systems, and keep supervisor informed of project status.  Requires, Associate degree or certification in Biological Science or related field, or equivalent combination of education & experience, experience handling biological samples, understanding of good laboratory, data and documentation practices, and experience with basic computer application.

Scientist 1 – Pleasanton, CA: 6+ Months Contract

This opportunity is with NGS workflow controls for the RSS assay development team that identifies and tests cutting edge reagents, technologies or protocols that are supporting the development of products in Oncology, Genetics, Infectious Disease and Automation/Sample Preparation. Areas of interest include short and long read sequencing technologies, low input and difficult sample preparation methods and creating integrated workflows. Candidates must be able to work in a collaborative, exciting, and fast-paced team environment.
Responsibilities: Operate & maintain equipment, interact with LIMS databases, complete projects in a timely fashion, research & development, and give presentations at weekly meetings. Additional responsibilities: Operation of different genomics analysis technologies such as next-gen sequencing, microarrays, real time PCR and ancillary equipment for quality control and validation; Develop, validate & apply methods for various genomics methods mainly focused on sequencing; Process include nucleic acid isolation and quantification, PCR amplification, library preparation, plate normalizations and Work with senior personnel, perform early development activity to create new workflows that are robust, cost-effective and time efficient; Collaborate with R&D to transfer new assays and methods to automation platforms; Work closely with IT group and instrument vendors to develop and implement automated workflows; Accurately and consistently record experimental methods, materials & results in electronic laboratory notebooks; Analyze data, evaluates results, form conclusions, and determine future experiments; Present findings or comprehensive project status reviews at internal/external seminars/meetings; Apply advanced technical writing & graphical skills to produce reports & documents; Prepare summaries, reports, presentations, manuscripts, etc.; Present early development work including scientific background information & project updates at internal staff meetings and at cross-functional team meetings; Determine all chemicals, reagents & supplies needed for a project; develop a strong knowledge of all related third-party vendors and their technologies and products; Establish and maintain productive relationship with personnel in development; orient & trains new Research Technicians & peers.
Requirements:  Strong Molecular Biology background or Biochemistry or Immunology background with strong knowledge of Molecular Biology;  Experience performing next-generation sequencing methods (Exome, whole genome, RNA sequencing) a plus; Bachelor of Science with a minimum of 2 years of lab experience.

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Aligning value proposition: From Preclinical to Market for Medical Devices


Tim Pelura, CEO, Surpass Preclinical CRO talked on how medical device companies can align their strategy, from preclinical to market, with a focus on the value proposition, at www.bio2devicegroup.org event.

We are operating under a new reality now where power has shifted to the payers and the providers, said Pelura.  Medical device companies are evaluated based on safety and procedural efficacy as well as cost and value.  Increasingly heightened regulatory scrutiny and tightening FDA regulations have led to increase in audits (which were up 40% in the last year) and warning letters are (which were up 24% over the last 2 years).  Due to regulatory and reimbursement challenges, medical device companies are focusing their R&D efforts on improving already approved devices, rather than developing innovative new products.  Meanwhile startups are finding the landscape challenging due to funding challenges and increasing costs of bringing new products to market.

Healthcare Infostep

Healthcare Infostep (Photo credit: Wikipedia)

Inkeeping with the reality of pressures on payers that are transmitted down, new healthcare delivery models are emerging, and therefore, patient pathways are being modified to obtain to obtain better outcomes, with less cost.  Medical device companies will need to work with new business models, that solve significant problems and reduce overall costs.  Companies seeking growth will need to expand their offerings to target underserved populations and lower socioeconomic classes.

In essence, it is about the value proposition offered by the new product or service, “what benefit you provide for who and how you do it uniquely well”, said Pelura.  He advised, these “must-haves” in a business pitch, “describe your target buyer, the problem you are seeking to solve, and why you do it better than the alternative”.

Pelura walked the audience through the process of arriving at the value proposition.  First, companies must define the problem they are seeking to solve and identify correctly the need to solve the problem.  Next, they should try to go after obvious problems, rather than aspirational or “good to solve” problems.  And finally, they should try to address acute or critical problems.

In defining a solution, they should try to generate many ideas and then measure the viability of customer adoption of each idea using gain/pain ratio; what the customer stands to gain versus the cost of adoption of the new solution.  The best solutions are those that offer game-changing benefits, with minimal modifications to the existing process or environments, said Pelura.  Go for “Disruptive Innovations, that are Non-Disruptive to Adopt”, advised Pelura.   Medical device companies must visualize the entire process or patient pathway to ensure that the new solution would cause minimal disruptions, in the whole process.

While new technologies often emerge with a focus on engineering and progress to bench testing and then plan preclinical, and clinical strategies and only then consider navigating regulatory, market, and reimbursement challenges; in actuality, they should invert the process.  They should begin with considering reimbursement challenges, analyze the competitive landscape, study the market opportunity, give thoughtful consideration to the regulatory challenges, then consider clinical and preclinical strategy, before embarking on prototype and bench testing.  Because if the value proposition is wrong then a company can end up with a product that no one wants or needs, resulting in considerable waste of precious innovation dollars and time, said Pelura.

Speaking of Surpass, Pelura shared that preclinical Contract Research Organization, Surpass is doing things differently.  While having deep expertise as a preclinical CRO in helping medical device companies with their preclinical in vivo and human cadaveric studies, Surpass also seeks to impact the system, by probing and assisting their clients with questions that go to the value proposition.  Surpass assists the clients in designing the most translatable preclinical study by understanding issues of clinical end points, product’s desired features and characteristics, all the while keeping in mind who would be operating the device, studies and activities that might need to be completed to demonstrate the products, performance, safety, and efficacy, as well as data that would be required to drive reimbursement and more.  This novel process ensures that any preclinical testing performed is aligned to the new product’s value proposition, hence helping save valuable healthcare innovation dollars.  

The session was followed by Q&A.

 

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JOBS – November, 2014


For the opportunities below, please send resume at wd_darshana at hot mail dot com.  Please indicate in the email how closely the job description matches your background and identify gaps, if any.  Also, indicate your current compensation and compensation expectations.  Please note: With the exception of the opportunities in China, other opportunities are only for local US based candidates, with valid US work visa (when need arises for applicants from other countries, I mention that under that specific opportunity).  The opportunities are in the order of priority from most important fresh opportunities to others that are in the process of being filled.

Quality Assurance Manager & Quality Engineer – North San Jose, CA
Quality Engineering background essential for both – more details with follow.

Document Control Technician – North San Jose, CA
Details with follow.

Director of Operations – North San Jose, CA
Experience running production lines, planning, project management from soup to nuts, people management, experience in quality, GMP, and class III device experience essential.  Full description will follow soon.

Analytical R&D Scientist – TX
Details to follow

Asceptic Process Manufacturing Engineer – North San Jose, CA
Details will be posted soon.

Balloon Assembly Manufacturing Engineer – North San Jose, CA
Full description will be posted soon.

Engineering Technician with Machning Experience – North San Jose, CA
Description will be posted.

Bio Technician – North San Jose, CA
Experience running immunoassays & chemistry assays in a lab plus MS in relevant field required.  More details to follow.

Director of Product Portfolio Management – China

A leading biopharmaceutical company in China, with a goal to bring best products at local prices to Chinese populace, has an immediate opening for Director of Product Portfolio Management, in beautiful Suzhou, China. See details below. Compensation includes attractive benefits package + salary + stock options + an opportunity to work in state of the art facility & make real impact.

Requirements:
A candidate must have a Ph.D. degree in Pharmaceutical Sciences, Biology or related disciplines and over 15 years of industry experience (or equivalent) of developing biologics, drug products and new formulations for various therapeutic areas for China and international markets.
* Demonstrated records of leading domestic and international generic drug product development that resulted in recent regulatory approvals in China, US or Europe
* Broad knowledge and experience about biologic drug product development including strategies and approaches, medical and market needs, and regulatory requirements in China and other major markets
* Extensive network with leading researchers in the research institutes and the industry who are engaged in biologics and innovative drug product development
* Excellent written and verbal language skills for communication in both Chinese and English

Responsibilities
This position, based in Suzhou, China, will report to the CEO and be responsible for leading the Product Portfolio Management Department to develop and manage drug product development portfolio for the company. A successful candidate will lead the department to leverage internal and external resources, establish and progress drug product development portfolio in alignment with company’s short term and long term business strategies and objectives.

Additional Responsibilities
* Build and lead the department comprised of functions including patent search, intellectual propriety (IP), product selection, cost analysis, budget planning and project management
* Collaborate with the marketing, medical, regulatory departments and manufacturing facilities to gain in-depth understanding of business needs, regulatory constraints and manufacturing facilities and capabilities
* Lead to establish R&D strategies in alignment with corporate business strategies by fully considering medical needs and marketing trends in different therapeutic areas, business priorities, regulatory constraints and manufacturing facilities and capabilities.

.jobs -- Cut To The Chase

.jobs — Cut To The Chase (Photo credit: Wikipedia)

Director of Analytical Research and Development – China

A leading biopharmaceutical company in China, with a goal to bring best products at local prices to Chinese populace, has an immediate opening for Director of Analytical Research & Development, in beautiful Suzhou, China. See details below. Compensation includes attractive benefits package + salary + stock options + an opportunity to work in state of the art facility & make real impact.

Requirements:
* A candidate should have a Ph.D. degree in analytical chemistry or related disciplines with more than 10 years of industry experience (or equivalent) in providing analytical support to API and drug product development.
* Demonstrated records of leading analytical development that resulted in recent regulatory approvals in China, US or Europe
* Extensive experience of establishing and implementing analytical control strategies (including specifications) and stability studies for innovative or generic drugs developed using scientific and systematic approaches
* In-depth understanding and practical experiences of implementing and operating under quality and regulatory requirements supported by successful passing GMP inspection and pre-approval Inspection
* Excellent written and verbal language skills for communication in both Chinese and English

Overall Responsibilities: This position will report to the Vice President of Quality, & be responsible for establishing and leading the Analytical R&D to support biological API, drug product and new formulation development for technology transfer, clinical supply manufacturing, domestic and international product registration and commercial manufacturing. A successful candidate will lead the department in collaboration with internal stakeholders and external partners to ensure drug product project progression, cost control and timeline while all technical, quality and regulatory expectations and requirements are met.

Additional Responsibilities:
* Establish and lead the Analytical Research and Development Department responsible for providing analytical support to API and drug product development portfolio
* Establish analytical laboratories by designing proper layout, equipping with analytical instrumentation necessary to support API, product and process development
* Build analytical teams with strong expertise to support API development including raw material testing, in-process control, API solid form and particle size control, and release testing as well as drug product development including excipient testing, in-process control and finish product release testing for conventional dosage forms (e.g., oral solid IR and MR, sterile products) and innovative drug delivery systems
* Implement standard operating procedures (SOPs) and best practices for analytical development activities and ensure technical, quality and compliance requirements are met
* Direct and ensure analytical project teams establish analytical control strategies, develop, qualify and validate analytical methods for API and drug product development, clinical supply manufacturing, registration and commercial manufacturing
* Project, identify, allocate and manage internal and external resources (including academic research institutes, CROs, and parent companies) needed to deliver analytical support to meet established timeline within budget
* Support regulatory submission, query responses and pre-approval inspections to ensure regulatory approvals
* Establish a good working relationship with regulatory agencies in China and other major markets. Participate and lead technical based engagement such as dialogues with regulatory agencies through industry associations
* Initiate and lead technical collaboration with external partners (including academic research institutes, CROs, and parent companies) to develop new analytical technologies or novel applications
* Provide technical assessment including due diligence to support business development opportunities
* Develop a training program for the department to ensure all essential training needs for technology, quality and compliance are provided

Director of Quality Assurance – Suzhou, China

A leading biopharmaceutical company in China, with a goal to bring best products at local prices to Chinese populace, has an immediate opening for Director of Quality Assurance, in beautiful Suzhou, China. See details below.
Reports to Corporate Legal Representative (as specified by law in China)
Direct reports – Manager of Documentation

Requirements: BS and 10+ years experience in QA for monoclonal antibodies & other recombinant proteins. Should be technical expert in QA & cGMP compliance including technical issues related in the manufacturing, testing & characterization of recombinant proteins; must have technical background to evaluate issues based on the science and not rely solely on historical precedent; must have experience in development of biopharmaceutical products for registration in the US and Europe, including experience in the preparation of documents that support regulatory submissions. Chinese language skill is a plus.

Responsibilities: Oversee Quality Assurance functions pertaining to release of drug substance & drug products; responsible for the controlled document system and the documents within the system including batch records, SOPs, validation records & other controlled documents; translating goals into action plan. Also responsible for staff development including cGMP training; ensure compliance with company policies & maintain safe work environment.

Project Manager – Pleasanton, CA
Innovative medical device company located in Pleasanton CA, has an immediate opening for hands-on project manager.  Experience with drug coated medical devices, drug coated balloon catheters, drug coated stents etc. highly preferred.  Also preferred mix of high level contributor who can work in the lab, doing studies, testing, process improvements, documentation etc. will be highly desirable.  Salary will be competitive and range between $120 to $150 K base, plus bonus.

Senior Electrical Engineer with Implantable Device Experience – Fremont, CA
There is an immediate opening in an exciting startup with innovative technology with a huge potential.  Requirements: EE background, medical device experience, and circuit design, FPGA, Verilog design, and schematic drawing experience required.  Need to be hands-on and will be working on a controller.  Pay will be in $130K range.

Catheter Engineer – Fremont, CA
Innovative medical device startup, located in Fremont, has an immediate opening for catheter engineer with 5-10 years baloon catheter development experience.  Salary will be commensurate with experience and will be in $100-$130 range.

Senior Manufacturing Engineer/ Manager – Sunnyvale, CA
Requirements include: Class 3, implantable, catheter, drug device combination products type of medical device experience.

Project Manager – Pleasanton, CA
Immediate opening for senior level project manager with medical device background.  Class III, drug coated device experience absolutely required.

Senior Python Automation Engineer – CA
There is an immediate opportunity for Senior Python Automation Engineer with 3+ years of Network Engineering experience (In Layer 2 and Layer 3 of networking protocols and features).

Biostatistician: Southern CA
There is an immediate opening for Biostatistician, with an innovative medical device company, located in Southern CA.  The position requires clinical experience.  The company is a leading developer of emerging microelectronic technologies that modulate nerve activity to treat disabling disorders, including chronic pain, depression, urinary incontinence and so on.

RequirementsKey Responsibilities:
– Act as a leader and subject matter expert for clinical study design and analysis.
– Collaborate with the rest of the Biostatistics & Data Sciences group on developing data collection and analysis strategies.
– Work closely with the Research Scientist, Project Manager, and Medical Director on development and execution of a range of clinical programs, including Feasibility, Pivotal, and Post-Market.
– Effectively communicate recommendations based on complex statistical concepts to Senior Leadership.
– Oversee and ensure the statistical integrity of all clinical programs.
– Lead the development and oversee the execution of the statistical analysis plans.
– Oversee the activities of the supporting Statistical Programmers in their implementation of statistical analysis plans.
– Represents Biostatistics on study teams and communicates with management and other team members regarding project/study status and timeline update
– Lead publication efforts in regards to data analysis and study results.
– Ensures the quality-controlled production of all tables, listings and graphs for clinical documents and publications.
– Independently lead research projects based on theoretical methodologies and/or publicly-available datasets to drive publications related to Biostatistics.
– Develop meta-analysis for existing clinical literature to enable data-driven strategic decisions for clinical program development and to support regulatory submissions.
– Collaborate with non-clinical colleagues (e.g. R&D, Marketing) on special projects.
– Ph.D. in Biostatistics/Statistics or a field with a comparable quantitative/statistical emphasis
– 2 years experience in Biostatistics/Statistics research– Excellent analytical and decision-making skills
– Excellent communication and presentation skills
– Strong independent statistics research skills
– Intermediate knowledge of SAS programming
– Excellent knowledge of experiment design and data analysis.

Marketing Product Manager – Southern CA

Global medical technology company and a leading developer of microelectronic technologies that modulate nerve activity to treat disabling disorders, including chronic pain has an immediate opening for Product Manager, at its Southern CA location. The Marketing Product Manager will be involved in all aspects of developing and launching devices.

Principle activities include:
– Working closely with cross-functional product development teams and generating voice-of-the-customer marketing specifications for product development
– Collecting feedback from customers throughout product development
– Supporting product commercialization activities across multiple internal and external groups such as design, packaging and labeling, regulatory claims, surgical technique generation, sales force education and operations planning.
– Developing and conducting market research
– Acquiring and analyzing feedback from key opinion leaders, current and potential customers, third party market research and internal stakeholders
– Possessing an in-depth knowledge of the healthcare industry in general and more specifically, the segments targeted by assigned products
– Participating and supporting a comprehensive launch plan and strategy for new product(s)
– Creating and implementing market development strategies to target key customers
– Developing product positioning, marketing messaging, and related marketing collateral
– Establishing relationships with key opinion leaders in the field
– Developing sales and physician education program

Requirements:
EDUCATION:
– M.B.A. or advanced degree strongly preferred
– Minimum BS degree.
– Degree in engineering or life sciences a plus
EXPERIENCE:
– 1+ years minimum experience of increasing responsibility in a marketing role
PREFERRED EXPERIENCE AND ABILITIES:
– Medical device industry experience strongly preferred; experience with Class III devices preferred. Technical or neurostimulation research focus.
– New product development or product management experience preferred
– Previous product launch experience
– Strong analytic and strategic thinking ability
– Ability to complete assignments of an advanced degree of complexity, working under little supervision on specific tasks or projects

Solidworks Drafter/ Designer – Southern, CA

Review and verify drawings Per ASME Y14.5M-2006 and Corporate Standard using ePDM system. Provide drafting and tool design support to the manufacturing, equipment design, process development groups. Create all appropriate mechanical drawings and appropriate documents. Create and implement technical studies & equipment installation qualifications.

– Model product concepts using current tool, analysis techniques, and technologies through use of parametric CAD software and other mechanisms. Designs components or portions of systems and modifies existing designs to develop or improve products and facilitate manufacturing operations.
– Perform Mechanical design/redesign of medical device products applying industry standards (e.g. ASME Y14.5M-1994) to detail drawings. Drafts tools and /or machines of varying types for use in the manufacture of company products.
– Create/modify/maintain documentation using tools that are tied to a data management system. Utilizes computer-aided design equipment and/or graphic tools such as, CAD, CAM or Solid Works.
– Provide support for OEM device documentation and Bill of Material structure support.
– Completes document packages by detailing parts and creating BOM and schematics following layouts, sketches and verbal instructions to ensure that all of the needed documentation is available for manufacturing process. Gathers information, makes studies, computes calculations, and prepares original rough layouts, sketches to present design proposal.
– Reviews and verifies design work of peers to check for compliance with standards and corporate procedures. Coordinates design criteria with engineering, manufacturing, tooling, material, and planning group such as ease of manufacture, availability of materials, and contractual specifications.
– Recommend: May review engineering order (EO) package by reading information on EOs (e.g. document description) and supplemental information (e.g., preliminary sketch) in order to identify missing information.
– May generate engineering change orders (ECOs). (CRM)
– May provide illustrations, animation and web publishing solutions that allow communication of 2D/3D product information for interactive assembly, maintenance/ restoration of documentation, product presentations and Federal and International compliance.
– Prepares and implement installation qualification protocols, and preventive maintenance procedures.
– Set up new equipment, ensures its satisfactory operation and instructs others to use the equipment properly.
– Participate in a team environment to enhance processes and product performance.

Minimum Qualifications:
– 5 years of experience working with SolidWorks in designing fixtures and tools.
– Familiar with ePDM
– Good understanding of the ASME Y14.5M

 

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Life Science focus at TiEcon, 2012


There were several panels that focused on Life Sciences and the mood was different at each of these sessions.  On day 1, a panel moderated by Mudit Jain focused on trends, challenges, and opportunities in this industry.  Almost all of the speakers, Dana Mead, Investment Partner, Kleiner Perkins Caufield & Byers, Renee Compton Ryan, Vice President, Venture Investments, Johnson & Johnson Development Corporation, Tom Fogarty, Founder, FogartyinstituteofInnovationand Katie Szyman, President, Medtronic Diabetes, painted a very bleak picture for this industry, in the years ahead.  The overarching tone was that the regulatory model is broken, regulatory hurdles are undefined and there is much higher unpredictability and risks in funding companies in the life sciences arena.  Until this model is fixed, the panel members stressed there would be fewer VCs willing to make sizeable investment in this space.  Various emerging markets seem to be more attractive and seem to be bigger growth sectors.

 

The panel on day 2, moderated by Halle Tecco, Co-Founder & CEO of RockHealth was more upbeat and discussed mobile health opportunities.  Panelist Alex De Winter, Partner at Life Sciences, Mohr Davidow shared that there was a lot of excitement regarding their portfolio companies mobile apps, driven by increased interest in wellness and staggering statistics around diabetes and obesity.  For instance, Aza Raskin’s company Massive Health is generating tremendous interest around its downloadable app that helps people eat healthier.  Technology is also often geography agnostic.  Mobile apps can originate anywhere and easily can be adapted for other geographies, said Winter.  In the opinion of Michael Nichols, Chief Privacy Officer at HealthTap, the landscape is also changing around the core theme of greater access to information and efficiency in healthcare.  Clive Smith founder of digital stethoscope, shared about the challenges posed by physicians in adopting new technologies on account of deeply entrenched old habits.  Jack Young, Lead Investment Manager at Qualcomm Life Fund, Qualcomm Ventures talked about the opportunities that exist in gamification with incentives to get people to adopt healthier lifestyle, which the insurance companies would find very attractive from reimbursement perspective.

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Challenges and tips for expanding business in China by Matt Levy at www.bio2devicegroup.org, February 14, 2012


Matt Levy, President, http://www.fiftyfivestar.com, discussed challenges and shared some insights and strategies for expanding business in China. China represents a huge manufacturing market for US multi-national corporations. China represents $14 Billion of medical device market and is expected to expand to $50 Billion by 2020.  Levy shared his 5-step commercialization plan as outlined below.

Step one should focus on customer centric, as opposed to product-centric strategy.  The company should have a US presence in the market, have the resources to establish the necessary infrastructure in China, have filed patent and trademark in China, have an international brand recognition, and have knowledge and expertise to do business in china or know where to seek help, prior to expanding the business in China.

Step two should focus on market research from secondary and primary sources, including expert interviews with current customers, distributors, KOLs, competitive overview of international and local competitors, delineate sustainable competitive advantage, and plan a visit to China.  A visit to China will accelerate the learning process tremendously, said Levy.

Levy proposed that step three is focused on developing a plan which should includes two elements, operation plan and marketing plan.  Operational plan should begin with selecting a proper entity, whether it is a rep office, a joint venture, or a wholly owned foreign entity.  Each of these have pros and cons which should be carefully considered.  Next step would be to establish US logistics including accounting, shipping, order processing and legal elements.  That should follow with establishing China logistics including office location, administrative aspects, organizational structure, field service and technical support elements, and recruitment of staff.  Levy shared insights on each of these aspects.  The operational plan should also include defining financial investment based on advice from local market expert.   The marketing plan should include product elements like patent filings, supplier sources, software aspects and manuals.  Distribution elements of the marketing plan should include consideration regarding whether it is through direct sales, or national or regional and/or hybrid distributors.  “Don’t ever sign a long-term exclusivity agreement with a distributor”, cautioned, Levy.  Finally, the brand building aspect of the marketing plan should include aspects regarding market segmentation, translating collateral, event planning, and customer identification.  And finally, the pricing strategy should be considered carefully.

Step four would focus on market execution with focus on brand building.  Chinese product name and key marketing message should be carefully selected followed by sales training and collateral development.  Early adapters and KOLs should be identified and marketing communication plan should be developed.

Finally, step five is about renewing and refining which should be based upon communication from customers, distributors, complete review of China’s growth metrices, it’s evolving compliance policy, and due consideration for high growth environment that is constantly evolving in dynamic China.

Levy discussed further details including considering cultural differences, regulatory climate, and IP protection.  Culturally, there is a lot of corruption ingrained in China and he advised not be naïve about it.  There is also lot of corner cutting which could be an issue for clinical trails, regulatory approval etc. later on.  Also the negotiation style is different, where frequently signing of a contract often signals the beginning of negotiation, rather than an end.  Work ethic, social norms, management style etc. are all practiced differently inChina, compared to theUS.  Regulatory climate is constantly evolving.  IP protection is an issue that should be carefully considered because enforcement does not widely exist. On the other hand, companies can loose IP, even without entering China, said Levy.

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