Sr. Reagent Manufacturing and QC Associate

Position Summary

This is an exciting position for anyone looking to develop and lead efforts in reagent manufacturing. The Sr Reagent Manufacturing Associate will initially play a key role in Design Transfer from R&D to Operations for all reagent related activities and will then be responsible for leading reagent formulation and associated acceptance testing activities.

This position will report to the Director, Assay Development.

Specific responsibilities include, but are not limited to:

Lead formulation and process development of reagents in IVD products.

Create reagent manufacturing and reagent QC work instructions, SOPs, and batch records as part of design transfer

Responsible for reagent and IVD product Test Method Validation

Perform reagent manufacturing activities and record in associated batch records

Perform analytical and functional QC testing according to work instructions and batch records

Work with QA to develop a process to release reagents to production inventory

Ensure traceability of reagents by following the company’s established procedures for lot number assignment and recordkeeping

Maintain regulatory compliance to applicable federal, state, and local regulations

Monitor Quality Control metrics for trend analysis

Identify problems that may adversely affect test performance and communicate to the cross-functional team

Draft or revise reagent manufacturing and QC documents as needed

Utilize job knowledge, judgment, and problem-solving skills to ensure quality

Work in compliance with cGLPs and cGMPs

Education/Skills/Requirements

Bachelor's degree in Molecular Biology, Biochemistry, Chemistry, or an associated relevant field or equivalent

2+ years of experience in a regulated reagent manufacturing environment

Prior experience with design transfer and manufacturing and QC scale-up

The candidate must be a team player who is self-driven, motivated, organized, analytical, detailed, and flexible in a fast-paced environment

Strong communicator with the ability to maintain open communication and collaboration with team members, management, and other departments

Ability to prioritize and adapt to changing environments while maintaining a high standard of quality

Experience with nucleic acid amplification technologies and/or RT-LAMP desirable