Responsibilities (What You Will Achieve)
- Provide technical support for biotherapeutic products (Quality Control Product Technical Support) in Andover, MA.
- Manage and facilitate analytical activities across the lifecycle of biological products; collaborate with cross-functional teams.
- Author and review GMP documents/reports; author/review technical documentation.
- Oversee qualifications, period of use, and extension of reference materials.
- Support change control, reagent studies, and instrument validation; ensure commitments/timelines.
- Author periodic review of method validations and annual product reviews.
- Manage method improvement, new technology implementation, lifecycle activities.
- Facilitate/perform method qualifications, validations, verifications, transfers, and comparability studies.
- Provide audit support and support regulatory responses; support investigations/root-cause analysis.
- Identify CI opportunities, resolve technical issues, and monitor analytical methods.
Minimum Requirements
- BA/BS + 6 yrs (or MBA/MS + 4 yrs; or PhD/JD any yrs).
- Proficiency with MS Office.
- Excellent written/verbal communication; strong interpersonal skills.
- Solid US/EU/ROW cGMP & GLP knowledge and auditing procedures.
- In-depth protein characterization/production process knowledge.
- Prior method improvement experience (study design to improve robustness).
- Protein analysis expertise: HPLC/UPLC, peptide mapping, CE/gel, carbo analysis, ICE, UV.
- ELISA/bioassay experience (advantageous).