Ashland, MA, United States
$110,000 - $130,000
3 months ago
This is an exciting opportunity for an ambitious scientist to lead the Biochemistry Operations function for a rapidly expanding Medical Devices manufacturing organization that have been able to contribute immensely to the US response to COVID-19 in manufacturing diagnostic testing kits.
- Overseeing a team of 6 scientists in ensuring the highest quality of products are manufactured for customers, with a strong focus on optimizing lateral flow assay designs and processes.
- Preparing assay validation reports and other assay-related documentation as required by FDA and ISO regulations.
- Leveraging technical expertise and published literature to help customers solve biochemistry scale up challenges.
- Leading and supporting biochemistry process design for new programs through scale-up to commercial production.
- Coordinating technical transfer of new assays and procedures for scaling up with Production department.
- Supporting customers in their pursuit of state-of-the-art Rapid Lateral Flow immunoassays development, including reagent screening, proof-of-concept, feasibility study, optimization, validation, and final product development.
- Managing the manufacturing of reagent batches for commercial production. Managing pilot deposition of reagents to support manufacturing.
- Writing GMP documents related to product manufacturing and quality assurance, progress reports, publications, SOP’s, MSDS, etc.
- BS, MS, or PhD in biochemistry, chemistry, or related field and a minimum of five years related work experience.
- Experience in a lateral flow production environment or lateral flow development environment
- Able to design and conduct robust and efficient experiments to solve difficult technical problems.
- The ability to provide guidance to scientists, lab assistants, and skilled production staff.
- General computer knowledge (MS Office Suite, statistical analysis packages).
- Laboratory skills: such as protein purification, antibody conjugation, solution preparation, or ELISA experience.
- Experience with 21 CFR 820, ISO 13485:2016, and Contract Manufacturing Organizations is desirable
This is a FTE salaried opportunity with a base salary range of $110,000 - $130,000 + employee shares & benefits.
You must be a US Citizen or Permanent Resident Holder to apply for this position, unfortunately no sponsorships are available.