Posts Tagged project management
JOBS – November, 2015
Posted by Darshana V. Nadkarni, Ph.D. in JOB OPENINGS on November 3, 2015
Please see below some of my immediate opportunities. All opportunities are for candidates located in the United States only. When sending your resume, please include details on your current compensation and compensation expectations. Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com.
Research Associate/ Scientist – San Jose, CA
Innovative, well funded startup with novel drug-delivery technology has an immediate opening for research associate, in San Jose, CA. Requirements include, solid track record in bioanalytical assays. Proficiency in HPLC, Elisa immunoassays, luminescence assays, fluorescence assays or related is required. Experience in quantitative analysis, variability analysis in tissue and plasma, experience in pharmacokinetics, and experience in biologics a big plus. Stocks and benefits make this a highly attractive opportunity to be involved in cutting edge technology, at grounds level.
CLS Lab Manager – Santa Clara, CA
The lab manager must possess an active, valid license issued by the State to perform high complexity testing pursuant to chapter 3 of Business and Professions Code or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties they are supervising; and– appropriate to the specialty or specialties for which they are consulting and, for the specialties of diagnostic immunology, chemistry, hematology, and microbiology, must–
(1) Have earned a bachelor’s degree in a chemical, physical or biological science or medical technology from an accredited institution; (CLS required)
(2) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty or subspecialty in which they supervise.
Duties and Responsibilities:
The lab manger shall be accessible to testing personnel at all times testing is performed by providing on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director.
The lab manager shall be responsible for ensuring that tests and examinations are performed in compliance with chapter 3 of the Business and Professions Code and Title 42, Code of Federal Regulations, Part 493 standards as published October 1, 1994, regarding clinical laboratories and–
(1) Be responsible for providing day-to-day supervision of high complexity test performance by a testing personnel;
(2) Be responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
(3) Assure that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications;
(4) Ensure that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning;
(5) Provide orientation to all testing personnel;
(6) Ensure proper training and competency assessment of all supervised laboratory personnel;
(7) Ensure that Proficiency Testing procedures are followed as specified in Proficiency Testing Procedure;
(8) Timely review of all data and programs specified in the Quality Assessment Procedure as authorized
Project Manager with strong hands-on engineering plus bio background – Milpitas, CA
This is an exciting opportunity with a huge potential upside in stocks in a very innovative company with unique drug delivery technology. Strong technical background plus background in pharma chemistry and 10+ years experience with microsoft projects is ideal. Drug-delivery device experience, a big plus.
Director of Quality Engineering – Milpitas, CA
There is an immediate opportunity for Director of Quality Engineering. It requires 10+ years experience in implantable device. Some pharma experience highly desired. Experience in implementing QE systems, a great plus. This is very exciting opportunity to be involved in multiple projects with huge upside, in stocks potential. Requires engineering background.
Director of Manufacturing Engineering – Milpitas, CA
There is immediate opening for Director of Manufacturing, that requires 10+ years experience in implantable devices. Experience with injectible drugs, pills highly desired. Strong hands-on expertise in tooling is required. This is very exciting opportunity to be involved in multiple projects with huge upside, in stocks potential (a once in a lifetime kind of an opportunity).
Post-doc opportunity – San Jose, CA
There are opportunities for some excellent post-docs for a drug delivery company. These opportunities are for candidates with recent Ph.D. in Biochemistry or related and interest in obtaining exciting industrial post doc opportunity with exciting startup.
Senior Biochem Scientist- San Jose, CA
More details will be posted soon. Meanwhile, candidates with strong drug delivery experience, please contact me.
Senior Quality Engineer – San Antonio, TX
* Lead Quality Assurance for R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation
* Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables
* Implement productive relationships with R&D and manufacturing suppliers and partners
* Work in a matrixed organizational structure to support facilities in CA & TX.
* Educate colleagues and support in-house uptake and implementation of these systems organization-wide
* Support the following functions: o Regulatory Affairs o Intellectual Property
* Business and Commercialization, including due diligence documentation
* Implement documentation systems, including electronic systems, under the functional direction of QA Director
based in San Jose
* Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial drug-device
and Class III experience desirable. At least 10 years experience, >15 years desirable.
* Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable
* Grown QA organizations with a hands-on, leadership- by-example and team-oriented approach
* Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE • Supported multiple complex projects and start-ups
* Developed and implemented design controls, documentation, and design procedures, protocols
* Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class II and III implantable devices
* Strong technical skills with demonstrated ability to provide hands-on solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator
Key Job Parameters
* Full-time position located in San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development
Senior Clinical Data Manager – Dublin, CA
Clinical Supplies Contractor – Dublin, CA
JOBS – November, 2014
Posted by Darshana V. Nadkarni, Ph.D. in JOB OPENINGS on November 2, 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.
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 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.
* 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.
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.
– 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
– M.B.A. or advanced degree strongly preferred
– Minimum BS degree.
– Degree in engineering or life sciences a plus
– 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.
– 5 years of experience working with SolidWorks in designing fixtures and tools.
– Familiar with ePDM
– Good understanding of the ASME Y14.5M