Senior Specialist, Quality Control

Position Summary: QC Specialist (GMP) in Quality Control to support testing of novel RNA therapeutics at Kendall Square, Cambridge, MA.

Responsibilities:
- Serve as SME in QC; partner with analytical development on method transfers from internal teams to external CDMO QC.
- Act as technical GMP lead overseeing external release and stability testing; troubleshoot method transfer; assist with critical reagent management; execute technical protocols.
- Oversee method qualification/validation at CDMO QC labs.
- Support stability data analysis and stability document reviews.
- Maintain stability sample inventory and ship stability samples to external labs/storage vendors.
- Partner with QA on datasheet review, QC investigations, OOS, CAPA, change controls, and deviation reports.
- Independently develop/author/revise/execute SOPs, protocols, reports, and related documents.
- Perform internal stability testing (compendial + biophysical: particle size, LNP encapsulation, etc.) and support routine analytical testing (e.g., HPLC, ELISA).
- Prepare data packets and peer-review data.

Qualifications:
- Bachelor’s degree (Chemistry/Life Sciences or related) + 5+ years relevant experience.
- QC experience, preferably stability.
- Hands-on experience with at least one: mRNA, LNP, potency assay, flow cytometry, PCR, ELISA, HPLC.
- Working knowledge of cGMP, GDP, and GLP.
- Data analysis/statistical evaluation and data trending.
- Experience with analytical method transfer processes; advanced technical writing; problem-solving.
- Independent, detail-oriented, able to meet deadlines and prioritize multiple projects; effective collaboration.

Compensation/Benefits (if applicable): Starting base pay $106,810–$129,430; health coverage; wellbeing programs; 401(k), disability/life insurance, and other protection; paid time off (flexible time off or vacation + holidays depending on location).

Application instruction: If you’re intrigued but don’t fully match your resume, apply anyway.