Senior Scientist I, Quality Control

Location: Cranbury, NJ (onsite 5 days a week). Laboratory and office‑based role.

About the role

The QC Physiochemistry Lead is responsible for the strategic and operational leadership of physiochemical testing in support of clinical and commercial biologics manufacturing. This role oversees method execution, data integrity, investigations, and continuous improvement while managing and developing a high‑performing QC team. The position serves as a key scientific and quality partner to Manufacturing, QA, Regulatory, and Client Program teams.

Responsibilities

• Provide leadership and oversight for daily QC Physiochemistry operations.
• Ensure all testing activities are conducted in compliance with cGMP, GLP, CFR, and internal SOPs.
• Lead and oversee data review, investigations, deviations, and CAPAs.
• Serve as site Subject Matter Expert (SME) for physiochemical testing and related investigations.
• Review and approve laboratory documentation, including notebooks, worksheets, protocols, and final reports.
• Drive continuous improvement of QC processes, efficiency, and right‑first‑time execution.
• Identify and mitigate risks related to method performance, capacity, and compliance.
• Support site readiness for regulatory inspections and client audits.
• Supervise, mentor, and develop QC staff; conduct performance management activities.
• Ensure appropriate training and qualification of personnel.
• Promote a culture of quality, accountability, and scientific excellence.
• Serve as QC lead or key contributor in client meetings related to testing, deviations, or investigations.
• Partner with QA and Regulatory teams to support filings and responses.
• Communicate effectively with Manufacturing and Technical teams to ensure timely testing support.

Qualifications

• Minimum 3‑5 years of hands‑on experience with HPLC, CE, ICIEF.
• Minimum 1‑2 years of management experience with direct reports.
• 3+ years of QC experience in the pharmaceutical or biopharmaceutical industry.
• Proven experience supporting clinical and/or commercial manufacturing environments.
• Strong working knowledge of QC operations for biologics, including method execution, data review, and laboratory compliance.
• In‑depth understanding of global regulatory requirements and guidance (cGMP, FDA, EMA, ICH, major pharmacopeias).
• Experience supporting IND, BLA, and post‑approval regulatory filings.
• Competency in investigations, root cause analysis, and CAPA.
• Ability to analyze complex data sets and make sound, risk‑based decisions.
• Proven capability to balance strategic planning and hands‑on execution.
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage competing priorities.
• Comfortable working in a fast‑paced, client‑facing environment.
• Flexibility to support some evening or global conference calls.
• Strong scientific understanding of protein and biologics analytical methods, including HPLC/UPLC, capillary electrophoresis (CE‑SDS, icIEF), identity methods, and protein concentration methods.
• Proficiency in advanced analytical instrumentation and laboratory systems such as LIMS, Empower, etc.
• Ability to critically evaluate method performance, trends, and assay suitability.
• Demonstrated people‑management experience in a QC or biomanufacturing environment.
• Ability to coach, develop, and engage scientific staff.
• Strong cross‑functional collaboration skills across QC, QA, Manufacturing, MSAT, Regulatory, and client teams.
• Ability to communicate clearly with internal stakeholders and external clients.