QC Senior Scientist 1

About the 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 entails operating in a fast-paced, highly dynamic environment with multifunctional groups/departments, including both internal and external stakeholders as needed.

Responsibilities

• 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.)
• Support the daily operations of the Quality Control group to ensure lab is in a state of readiness for both testing and client audits.
• Support SOP generation and revisions, item specification revisions, protocol generation, final report preparation, data summary, testing, and data trending.
• Support management of change controls, CAPAs, investigations, and other related documentation as needed.
• Support method onboarding, including method transfers, qualifications, and validations as needed.
• Support stability programs as needed, including pull forecasts, scheduling, and adherence to timelines.
• Support 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.

Qualifications

Minimum Qualifications:

• Bachelor’s Degree in Biology, Chemistry or related Life Science discipline with 6–10 years of experience in the biopharmaceutical industry
• OR Master’s Degree in Biology, Chemistry or related Life Science discipline with 5+ years of experience in the biopharmaceutical industry
• OR PhD in Biology, Chemistry or related Life Science discipline with 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.

Skills

• 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.

Pay

Pay range: $68,000–$98,900 per year. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or