R&D Director, Ameditech
Ameditech, an Alere company, is searching for a talented Director of R&D who will also have a leadership responsibility and influence in our manufacturing division. This is an excellent opportunity for a scientific leader, preferably with a diagnostic or immunoassay background, to own and deliver on a large scope for a small organization while solving complex problems that arise throughout the design and development of product(s). The successful candidate will be an assertive, team-oriented, open-minded individual who is capable of managing their own aggressive timelines with minimal supervision. This role will report to the General Manager and work directly with internal team members such as: Research Scientist, Research Associates, Production Chemists, and lower level staff. Travel requirement is expected to be 10-20%, as needed
Goals & Main Responsibilities:
- Effectively lead the organization to achieve site R&D goals by getting results through others and from self.
- Ensure manufacturing can meet customer needs for regular production while providing escalation support for customer inquiries and complaints.
- Develop employees in their behavioral and technical leadership and in taking informed risks.
- Become the expert across our parent company (Alere) for the technology used and how it is implemented in lateral flow DOA immunoassay products in urine and saliva, with and without a reader.
- Lead R&D organization with 5 direct reports and oversee the production chemistry group (one manager and 4 chemists/techs) including goal-setting, allocation of projects, planning, budget, spending, personnel responsibilities
- Direct the group strategy and lead 1-2 key projects while doing benchwork about 50% of the time.
- Define, author, and execute verification and validation studies and summarize relative data in reports.
- Partner with marketing and regulatory to define regulatory strategies for 510k submission studies and then execute studies and provide feedback to general manager and marketing on product capabilities.
- Oversee production chemistry and help resolve escalated technical production issues and customer complaints.
- Mentor and coach research and development and technical manufacturing staff.
- Apply creativity and innovation in designing a product that meets the needs of the customer and is robust and manufacturable. This will involve the selection of antibodies and antigens as well as other materials in addition to design of the collectors and other plastics.
- Use analytical techniques and design experiments to characterize what influences product performance and conduct optimization studies to get to the best design.
- Navigate the design control aspects of development and ensure development meets FDA design control requirements with compliant and complete design history file.
- Optimize use of the budget with the combination of research associates and scientists.
- Ensure revenue stream by keeping production keeps going while keeping customers happy by solving their problems.
- Properly manage project portfolio as well as ensuring each individual project is well-run with aggressive but realistic due dates.
Desired Skill Set & Experience:
- Preferred PhD in Chemistry, Biochemistry, Bioengineering or similar. MS and/or Bachelors level candidates with strong demonstrated experience will also be considered.
- Ten or more years of experience in the Medical Device, Diagnostics, Biotechnology, or Pharmaceutical industry.
- Previous work experience relating to point of care immunoassays, lateral flow strips, and/or microfluidics devices is a plus.
- Background and experience in Product Development, preferably medical device/diagnostic, and Regulatory/510k submissions
United States of America-California-San Diego
General & Administrative
Alere - 2 years ago
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