QC Senior Scientist 1

Your Role

As a QC Senior Scientist I, you will support the daily operations of the Quality Control Group activities which include performing a wide variety of analytical testing methods including raw material testing for raw materials, consumables, stability, in-process, and final product testing. The role will entail operating in a fast-paced, highly dynamic environment with multifunctional groups/departments, including both internal and external stakeholders as needed.

• Support the daily operations of the Quality Control group to ensure raw materials, consumables, stability, in-process, and final product testing are completed by assigned deadline (i.e. pH, Osmolality, TOC, Conductivity, Chemical ID, HPLC, FTIR, CE-SDS, Biochemical analysis, ELISAs, Cell Culture, PCR (qPCR & ddPCR, etc.)
• Supports the daily operations of the Quality Control group to ensure lab is in a state of readiness for both testing and client audits.
• Supports SOP generation and revisions, item specification revisions, protocol generation, final report preparation, data summary, testing, and data trending.
• Supports management of change controls, CAPAs, investigations, and other related documentation as needed.
• Supports method onboarding, including method transfers, qualifications, and validations as needed.
• Supports stability programs as needed, including pull forecasts, scheduling, and adherence to timelines.
• Supports raw material qualification activities for commercial clients as needed, including coordinating material acquisition, qualification testing, and reporting within provided timelines.
• Communicate effectively with the internal and external network partners, and the Product Teams
• Promote a safety-first culture
• Act as potential resource of information for the junior analysts

Who You Are

Minimum Qualifications

• Bachelor's Degree in Biology, Chemistry or related Life Science discipline
• 6-10 years of experience in the biopharmaceutical industry
• OR Master's Degree in Biology, Chemistry or related Life Science discipline
• 5+ years of experience in the biopharmaceutical industry
• OR PhD in Biology, Chemistry or related Life Science discipline
• 3+ years of experience in the biopharmaceutical industry

Preferred Qualifications

• Experience in Quality Control performing analytical methods such as Compendial testing, FTIR, UHPLC, Spectroscopy, CE-SDS, Cell Culture, ELISA, PCR (ddPCR & qPCR), Potency, FFU, PFU, and Flow Cytometry.
• Experience with providing technical advice and support for client and regulatory audits/inspections via meetings/teleconferences.
• Experience managing Stability programs
• Experience managing Raw Material qualification activities
• Experience onboarding new methods into QC (Method Transfers, Qualifications, and Validations)
• Strong critical and analytical thinking skills for effective problem-solving and outcome improvement.
• Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH quality guidelines.
• Technical Skills: Proficiency in analytical techniques (e.g., ELISA, HPLC/UPLC, qPCR/ddPCR, spectroscopy, cell-based assays); GMP documentation, instrument maintenance; basic programming or data analysis tools.
• Regulatory/Quality: Knowledge of governmental regulatory guidelines relating to the manufacturing of biologics (cGMP, ICH guidelines, and QA/QC systems); Experience with Quality Management Systems to document investigations, change controls, and CAPAs.
• Soft Skills: Excellent scientific communication (written and oral), problem-solving, time management, collaboration, adaptability, and mentoring ability.