Posts Tagged medtech
Please 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.
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.
With shrinking pool of serious early stage life science investors and stringent capital requirements, the path for medtech companies has become greatly challenging. As is the case every year, Wilson Sonsini Goodrich & Rosati 2017 Medical Device Conference provided a forum for addressing challenges faced by new medtech companies as well as opportunities presented by current trends.
Various speakers and panels addressed these issues from diverse angles and perspectives. Following a welcome address by Casey McGlynn, an early morning panel moderated by Donna Petkanics addressed new models for medtech investing. Panelists Andrew ElBardissi (Deerfield Capital), Eric Milledge (Endeavor Vision SA), Leighton Read (Brandon Capital Partners), and Valeska Schroeder (KCK Group) discussed how the investors are adapting their financing strategies and business models in response to the newer challenges that medical device companies face. Milledge opined that it is now crucial for medtech companies to get some regulatory approval before seeking to raise money. Even CE mark could help, said Milledge. ElBardissi offered that if the company is US based and focused on US commercialization strategy then EU approval does not help. He advised that medtech companies “keep the head down and focus on US approval UNLESS there is capital efficient advantage of focusing on EU”. Schroeder said their fund was “geographically agnostic” but they believed that for an early stage medtech company it is important that they not “simply throw capital without a plan”. but there are values you can get out which may not be revenue based but you can get close to your customer base etc… not go in every country but choosing a small no. of country to go through. Read observed that a company seeking to create larger returns must go after larger markets.
With the current challenges medtech world has become more global as companies and investors are finding win-win solutions through newer models of partnering by going across continents and countries. Geographically, Pacific Rim has emerged as hot collaboration frontier. A panel moderated by Elton Satusky with CEOs Yue-Teh Jang (Medeon Biodesign), Kewen Jin (Serica Partners, Trevor Moody (M. H. Carnegie & Company), and Norman Weldon (Partisan Management Group), who completed such collaborations, financings and mergers with companies and investors in Asia discussed how these transactions may be structured. Another panel moderated by Jack Moorman (US-Japan MedTech Frontiers – USJMF), with panelists Kenichi Hata (Terumo Corporation), Masazumi Ishii (AZCA Inc.), Yuichiro Morimoto (Enplas Corporation), and Richard Packer (Asahi Kasei Corporation) discussed collaborations between Japan and Silicon Valley. Japan has emerged as a major partner in medtech OUS financing and growth strategy.
Increasingly there is a pressure on medtech industry that is unlike most other industries, to show value. Many organizations have now come up with ways to define and measure value creation. Among them, AdvaMed has developed a new framework to assess the value of medical technologies and diagnostics in a broad, patient-centric approach. A panel moderated by Donald May (AdvaMed) with panelists Maneesh Arora (Exact Sciences Corp), Jeff Farkas (Medtronic), and Jo Carol Hiatt (Kaiser Permanente) addressed how companies may leverage value creation to make internal business decisions to allow for more efficient use of capital and to drive discussions with potential investors as well as to keep track of milestones during the commercialization process.
AdvaMed model focuses on following drivers of value creation, 1) clinical outcomes, effectiveness and utility measures 2) non clinical patient impact including impact on caregivers, families, ease of product use, ease of care, financial impact etc. 3) new drivers around value based purchasing, care delivery costs, reduction in readmissions etc. from provider perspectives, and 4) broader public impact on population and communities in terms of whether or not the technology reduces overall cost to the system, helps identify diseases, helps employers reduce absenteeism and so on. May said the model begins with the patient and goes on to incorporate multiple stakeholders and values for all may not always be aligned or the time frames may differ. As an industry, “we need to think of appropriate levels and types of evidence as we think of new value based models of integrated care”, said May. Speakers discussed the need to move away from one number and focus on broad picture with many factors that include clinical as well as economic value, in order to get better outcomes while reducing costs.
As is the case, WSGR medtech conference provides an excellent forum for investors, startups, and professionals in the industry to come together in a spirit of learning and collaboration. And compared to previous years, it seemed to be even more well attended with hallways abuzz with discussions on partnering. As always, the conference ended with short presentations from select few startups and the announcement of the $25,000 grand prize and Medtech Innovator Award. But the best was reserved for the last. More networking happened and deals were done as attendees mingled with good food at the reception and as the best wines were uncorked and venture capitalists served as sommeliers and poured wine for the attendees.
Changing World of Medtech Investors (includes Software, Big Data, Mobile, Biotech & more) – 2015 WSGR Conference
While there has been a decline in traditional medtech investments, non-traditional investors are investing in new and emerging areas, in medtech. Software and IoT investors are interested in containing hospital costs and increasing operational efficiency in healthcare institutions. Biotech investors are interested in alternative therapies, and internet investors are looking at ways to change the way devices are sold and big data investors are looking at opportunities to contain disease outbreaks and better manage large disease populations. International investors are tapping US expertise to build medtech businesses at home.
A panel at WSGR 2015 Medical Device Conference, moderated by Uday Kumar, Founder and CEO at Element Science Inc., addressed the changing world of medtech investors. Joining Kumar on the panel were Tom Rodgers, SVP & Managing Director at McKesson Ventures; Andrew Atwell, Principal at Global Innovation Center, Strategic Investments Group; Asha Nayak, Global Medical Director at Intel Corporation; and Conrad Wang, Senior Director of Corporate Development at Medtronic. Below are some highlights from very interesting panel discussion on changing face of medtech investment.
According to Wang, Medtronic vision is to be a collaborative solution provider in healthcare, with a specific focus on new therapies and geographic diversity of emerging markets. His advice to entrepreneurs, “focus on how your solutions can create value”. Instead of being enamored by a technological enhancement, entrepreneurs should keep in mind the impact that the new breakthrough may have on the stakeholders in the healthcare delivery chain. Due to a combination of factors, chronic conditions are increasing globally. Medtronic looks for opportunities that would enable healthcare providers from engaging in episodic care of chronic diseases to providing continuous care.
Atwell said there are numerous opportunities in the Big Data space, particularly in consumer generated data. “Our main driver of revenue are mobile devices”, said Atwell. There are also many challenges. For instance, it is challenging to get accurate data and see meaningful trends. It is also a challenge to understand early on how large the market might be and how quickly adoption may happen. Atwell said his group invests in early and seed stage to A and B rounds and typically invest from $250K to $3M, in any given opportunity. “We focus on building collaboration among experts from data analytics, health IT, and workflow efficiency”, said Atwell. He further observed, “additionally, we also look at behavior change space since there is so much access to individuals through their mobile devices”. Even if they may not help exert deep influence and impact in changing behaviors, mobile devices can exert significant influence over much larger population and can be an effective behavior change tool, said Atwell.
According to Nayak, Intel approach is to provide a piece of healthcare solution that fits in enhancement of health and quality of life, while keeping in mind TCO or total cost of ownership, in healthcare. Her advice to entrepreneurs, “you should know if you are able to provide a piece that will fit in total solution, even if that may be a few years later”. From consumer devices, typically wearables, an entrepreneur should be able to harness value in a trustworthy manner. There are some key questions that an entrepreneurs must ask. 1) Is the data trustworthy, not just in accuracy, but can it be consistently used by the right person? 2) With wearables, one needs to add unequivocal value and discern it from gobs of data. 3) An entrepreneur must consider how it will fit into the current workflow without adding more time to the system. Entrepreneurs often don’t get this piece, said Nayak. 4) Security of data is critical. Anytime data needs to be securitized, any time data moves, Intel makes money on it, said Nayak. 5) How is the cost and care impacted through wearables. Nayak said, Intel is interested in building ecosystems and platforms around the notion of building long term improvement in healthcare, at lesser cost. Intel invests in all stages from seed to commercialization. “My group is interested in partnership, and all of our investment is strategic”, said Nayak. Many areas of interest include, telemedicine, patient management of telemedicine, management of chronic and acute care and also precision medicine, genomics, and analytics that can extract data, said Nayak.
According to Rodgers now the focus is on whether or not an entrepreneur can you navigate the carpteted area of hospitals and provide actual solution that makes a difference. His advice to startups is to position devices as service. Device can also be a powerful tool to capture data to ultimately keep people healthy, said Rodgers. However, average provider does not have the time or the training to deal with the deluge of data. In order for the data to become actionable, we may need a whole layer sitting in between the patient and the provider, monitoring the datasets, observed Rodgers. He also advised that entrepreneurs may focus on emerging growth areas and shift to models that enable direct consume care. We focus on strategic areas, not tactical, said Rodgers.
The year is coming to a close and here is a last blast of opportunities. Please note: With the exception of the opportunities in China, other opportunities are only for local US based candidates, with valid US work visa. 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. The opportunities are in the order of priority from most important fresh opportunities to others that are in the process of being filled.
Principal R&D Technician – Fremont, CA
A company that develops advanced injection technologies to simplify the complexities of the cardiac cath lab, has an immediate opening for R&D technician.
* 9 years of electromechanical technician experience
* 2 year Technical School degree in electromechanics or related field or a combination of education and experience
* 2 years of computer aided design experience
* 2 years experience directing and leading the work of others
* Problem solving skills with the ability to interpret drawings, schematics, and specifications
* Experience using CAD-3D Modeling
* Effective verbal and written communication skills
* Moderate level of computer experience including MS Office Suite and SolidWorks
* Demonstrated experience using a multimeter, soldering iron, oscilloscope, and spectrum analyzer
* High degree of organization skills and high attention to detail
* Ability to prioritize and handle multiple tasks
* Ability to work independently with limited supervision
* Proficient at specifying and evaluating electrical components based on performance, lifetime, and availability
* Demonstrated project management experience
* Demonstrated test report-writing experience
* 4+ years of computer aided design experience, * SolidWorks Proficient, * Experience providing technical support to circuit board manufacturing assembly, * Demonstrated knowledge of and familiarity with embedded systems and RF electronics, * Product development experience in a federally regulated engineering environment (FDA, ISO), * Experience defining, writing, and conducting test plans and reports
Job Description & Responsibilities
Performs specified electromechanical engineering support activities under the guidance of an Engineer or Technical lead related to electro-mechanical design of medical device technologies, product and performance testing, and continuous improvement of the product design. The position is responsible for design, fabrications, assembly, validation, and implementation of development products and fixtures to support the design transfer of products into manufacturing operations.
Primary Duties and Responsibilities:
* Designs fixtures and test methods for validating product design and performance. Responsible for managing the ordering and delivery of fixture components and items from vendors or the internal Model Shop.
* Executes testing and validation protocols, records and analyzes data, and provides written reports to engineering team.
* Supports Product Development efforts at early stages up to design transfer. Provides support to engineers throughout the implementation and development cycles.
* Performs hands on activities such as design validation, pre-production assembly, testing and other technical activities to assist in product development.
* Assists engineers in identifying and resolving hardware design issues. Diagnoses the cause of electrical failures of circuit boards and operational equipment.
* Uses Solid Works CAD system to sketch and design fixtures and devices ensuring form, fit and functional requirements are met. Responsible for basic analysis of design in partnership with an Engineer.
* Responsible for initiating documentation changes and providing redlines to maintain the product information structure. Communicates issues and opportunities to engineering department to ensure bill of material (BOM’s), prints, process, forms, records, etc. are relevant and up to date.
Technical Engineering Support:
* Partners with Designers and Engineer, to develop and improve products, designs, fixtures, and process activities in the interest of continuous improvement and establishment of a Lean environment.
* Initiates design changes and coordinates the change order process to release product per the company’s Quality Management system. Responsible to maintain the design and information structure for use in the ERP system and
engineering data base (PDM) DB Works. e.g.; BOM’s, prints, process, forms, records etc.
* Implements changes and maintenance of PDM and CAD systems as required. Assists IT and Technical Documentation Writer in annual CAD system updates, user rights management, and data base management. Creates and edits DB-Works and Solid Works API programs.
Quality Assurance Manager & Quality Engineer – North San Jose, CA
Quality Engineering background essential for both – more details with follow (feel free to send resume).
Document Control Technician – North San Jose, CA
Details with follow (feel free to send resume).
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 (feel free to send resume).
Asceptic Process Manufacturing Engineer – North San Jose, CA
Details will be posted soon (feel free to send resume).
Balloon Assembly Manufacturing Engineer – North San Jose, CA
Full description will be posted soon (feel free to send resume).
Engineering Technician with Machning Experience – North San Jose, CA
Description will be posted (am submitting resumes).
Bio Technician – North San Jose, CA
Experience running immunoassays & chemistry assays in a lab plus MS in relevant field required. More details to follow (feel free to send resume).
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.
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
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.
* 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.
Director of Analytical Research & 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.
* 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.
* 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.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on January 27, 2014
The OneMed forum conference was launched in January of 2008, when economy was showing all signs of progressing to new heights, with an objective to showcase innovation in medtech. The conference aimed to bring together the companies and investors, during the large influx of healthcare investors and executives, during the JP Morgan Healthcare Conference, in San Franciso. Fast forward to 2014 and we are perhaps just emerging from one of the worst recessions; a downturn that hit the medtech sector more than any other industry segment.
This year, the location of OneMed Forum was changed and the venue was moved further away from the JP Morgan Conference. Since the weather in SF was gorgeous, it was not a problem; but if the venue continues to be further away in future, and in the event of cold and rainy weather, it can have an impact and lower the attendance at future OneMed events. This year also OneMed event seemed to be sparsely attended, although that appearance might also be enhanced because the meeting rooms were spread out on two different floors and there wasn’t a single spill out location for the participants to meet and network – another problem with the venue.
There was also a palpable difference between the JP Morgan conference and the OneMed Forum, this year, in terms of optimism. While biotech and pharma sector is returning to pre-recession levels with a large number of IPOs and higher numbers of dollars raised, medical technology companies have yet to see significant investment dollars. On talking with the participants, I heard a note of disappointment regarding low attendance from VCs and other investors, just like in the last few years.
However, despite slow pickup and staggering growth in the medtech sector, it is transforming and the companies are learning to operate more efficiently. It is also recognized that healthcare is at a critical point and medical innovation will have to address some key challenges. Various panels and speakers at the OneMed Forum, addressed the changing healthcare landscape and how the future of health and medicine will need to be shaped, in the coming years to address the key issues.
Personalized Medicine Panel discussed the promise offered by customized diagnosis and treatments, in lowering the cost and increasing effectiveness. Panel sessions addressing the JOBS Act and the Affordable Care Act, explored the impact of the legislation on cost of care and access to care. Companies and solutions that may be poised to offer effective healthcare solutions and may also present interesting investment opportunities were highlighted. In somewhat grim medtech landscape, digital health is emerging as the hottest new trend, with much potential. The Digital Health panel discussed the impact of Affordable Care Act in increasing information transparency and empowered consumers taking greater control of their health information. The changing role of the patients/ consumers will require change in the healthcare delivery and transformation in the business model.
A panel addressing “reimbursement strategy after the affordable care act”, discussed impact of medicare payment rules on medtech and hospital markets. The panel also discussed trends in coverage and payment for newly emerging molecular diagnostic tests. One key advice from the panel was that thinking upfront about the reimbursement strategy will be increasingly more important for companies with new, innovative products. A panelist also suggested that during clinical trials, companies can also think about reimbursement and instead of doing only what may be required by the FDA, if they can also collect reimbursement data then they would come out ahead. During innovation, the companies should relentlessly focus on disease management, and that would lead to them to appropriate and effective reimbursement strategy, advised the panel.
Financing and IPO issues were addressed in various panels. One interesting panel on Crowdfunding discussed a handful of portals that are beginning to raise some capital for emerging growth companies. One investor who was attending the panel, later told me, that it is too early to give an opinion on what kind of success this strategy would yield, but he had some grave concerns. AdvaMed CEO’s Unplugged Panel featured some of top leaders of the MedTech industry, who shared their insights on key challenges facing the industry. Stuart Randle, CEO of GI Dynamics advised startups to focus on crucial healthcare issues including obesity. He also advise companies to pursue capital intensive strategy, and at least initially sell products outside the US. Scott Brooks, CEO of Regenesis Biomedical, advised startups to get good legal and regulatory counsel early on. Patrick Daly, CEO of Cohera Medical was optimistic about the future of MedTech. “IPOs are coming back, M&A is picking up, and dollars are rolling in, big companies have record levels of cash, and I feel positive”, he said.
One of the most prolific financiers, Bill Hambrecht gave a keynote address. Hambrecht has over 500 IPO’s to his credit that include seed level funding in nascent industries. Although I did not attend the keynote, I heard some highly positive comments from an attendee. Steven Burrill, who has been at the helm of innovation in healthcare and shares and who regularly shares his insights through his annual reports, gave a second keynote. Again, I missed the address but both keynotes were major highlights of the event. Throughout the conference, over 800 emerging companies gave presentations. Following the presentations, partnering and breakout sessions gave the opportunity for conference delegates to meet the CEO’s of these companies.
Although it may seem hard to believe, it appears that now the MedTech sector has nowhere to go but up. The industry has learned some hard lessons, the companies are lean, operating with greater efficiency, spending cash wisely, and instead of hawking next new technology, they are focused on key problems facing the healthcare industry, and on providing effective solutions. If the healthcare providers are not eager to incorporate some of the solutions, then it will happen out of necessity. It will become incumbent upon the healthcare industry to implement solutions offering greater ROI in terms of improved health and lower cost. Healthcare providers will be looking for solutions that provide digital and point of care diagnosis and health monitoring and treatment options and solutions from personalized medicine and genomic health. Let us stay tuned for some cool innovations from the MedTech sector in 2014. Senior Analyst at Wells Fargo, Larry Biegelsen has also observed that not only acceleration in healthcare spending is expected in 2014 but there are number of other tailwinds including, “emerging technologies and emerging markets contributing more to growth and a more industry-friendly FDA, which should lead to faster approval times for medical devices”.