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For the opportunities below, please send resume at wd_darshana at hotmail 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).
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
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on July 3, 2013
Wilson, Sonsini, Goodrich, and Rosati 2013 Medical Device Conference (www.wsgr/news/medicaldevice.com) focuses on understanding the opportunities and challenges in medical device sector. A panel of experienced CEOs discussed the challenges of getting a new medical technology to market, in the current environment, and shared insights to help overcome early challenges and obtain commercial success.
David Bruce, President and CEO of Arstasis www.arstasis.com shared about how they implemented strategies to accelerate the commercial growth phase of the company. Companies need to define their market and pick the customers, and then figure out how to get through to them, said Bruce. Arstasis was clear that they needed to succeed in the US market and reach the customers with direct sales force. Arstasis offers self-sealing access for femoral catheterizations, securely, without leaks, and with drastically reduced complications. Bruce said that innovative product requires education and going after early innovative types, the risk takers, and sales reps trained to walk away from targets that are not good.
Keith Grossman, President and Director at Conceptus www.conceptus.com , discussed the challenges that come with lack of clear focus. Conceptus, a medical device provider of women’s health market, has a non invasive tubal ligation device that can be placed non-surgically and is more effective than having the tubes tied. It is also allows the doctor to make more money, while being less expensive for the payer. Yet it hit a wall. The company had a lot of people on the ground and was putting a lot of money into sales and marketing efforts. However, there was little clarity on how the customers were segmented and while a lot of customers were being trained and lot of new customers were generated, the company was not doing enough work with existing customers. The sales people were selling more and more products with single digit margins. After clarifying the focus, dramatic changes were made and within 6 quarters it led to double digit growth. Learning from the mistakes, Grossman said, they started too broad and were not penetrating the market deep enough because sales team lacked a guiding strategy. There was misalignment between the marketing message and the sales strategy and there was confusion regarding whether they were looking for penetration or profitability.
Christopher G. Chavez, Chairman, President, and CEO of TriVascular www.trivascular.com , discussed the technology that focuses on serving patients with aortic disease. Traditionally abdominal aortic aneurysm required high invasive open surgical procedure with high risk of mortality and other complications. EVAR or endovascular aortic repair procedures dramatically reduced complications. Trivascular’s initial product offerings are novel endovascular grafts focused on significantly advancing EVAR and addressing this $1B+ market. This is a hugely compelling, underserved, unmet need, said Chavez. They are seeing excellent outcomes in trials and are going into first in man, later this year. To address the marketing challenge, the company plans to focus on creating service excellence, in addition to strong field rep training program and building direct sales force in US and Germany.
Tom Prescott, Director, President, and CEO of Align Technology http://www.align.com shared that the company vision is to help people get beautiful smiles. Align Technology pioneered the invisible orthodontics market, with the introduction of the Invisalign system, in 1999. “Be patient for success, be impatient for patient success”, said Prescott. Marketing is about behavior change and it happens with energy, effort, and commitment.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on November 20, 2012
Roger Stern, Founder and CEO of Stellartech (www.stellartec.com), shared medical device BARRX Inc. (www.barrx.com) success story from idea to exit, at Bio2DeviceGroup (www.bio2devicegroup.org) event. Stellartech was founded in 1988 by Roger Stern, with a goal to develop innovative electronic devices, specifically in the field of development and manufacture of complex energy delivery systems and other sophisticated medical equipment. Stellartech is responsible for the development of many “firsts” in the medical device arena. Recently, Barrx Medical (www.barrx.com), a company co-founded and incubated as a virtual company by Stellartech Research Corp., with two physician partners, was acquired by Covidien, for $325M + milestone based payments.
This venture began when Stern was approached in the year 2000, Dr. Robert Ganz, a gasteroenterologist and his colleague, with a definite clinical problem. A serious condition called Barrett’s esophagus develops after the lower esophagus is repeatedly exposed to acid reflux disease, which causes a cellular conversion to occur. Eventually about 1% of Barrett’s patients develop full fledged esophageal adenocarcinoma. What is striking however, is that the risk among Barrett’s patients of eventually developing the cancer is 30 to 125 times higher than people without this disorder. Additionally, due to changing diet and lifestyle, cancer of the esophagus is one of the fastest-growing cancers in the nation, is often fatal, and until now, Barrett’s condition was left untreated, and only monitored.
One of the early challenges was due to the fact that the lining of the esophagus is very thin and destruction of deeper tissue layers can result in stricture formation (narrowing of the esophageal lumen), in turn making it difficult or impossible to swallow food. Stellartech’s challenge was to design a system that can precisely measure the esophagus and then ablate the superficial lining, while simultaneously preserving the underlying tissue. Stellartech’s eventually developed proprietary ablation system comprises of a balloon catheter around which a band of RF electrodes is wrapped. Along with the endoscope, the catheter is inserted into the esophagus, where the balloon is inflated, so that it expands and presses against the walls. When the operator presses on a foot pedal, a generator connected to the balloon delivers a rapid burst of RF energy to the electrode band mounted on the balloon catheter. Within a few seconds, RF energy is delivered circumferentially to several centimeters of esophageal tissue, while controlling the depth of penetration to avoid deeper damage to the healthy tissue. After removal of the balloon, these treated cells slough off the walls, making way for healthy new cells to grow in their place.
This is a fascinating story of how a medical device company started with identifying and addressing an unmet patient need. Stern shared the milestones achieved, the fund raising cycles that led to further development of the product and clinical work needed to commercialize it. The procedure is now performed on an outpatient basis that allows the diseased esophageal tissue to be ablated and Barrett’s patients to be treated, at early stages. The talk was followed by Q&A.