Sr. Scientist - QC Microbiology

About the role

Celltrion is a leading biopharmaceutical company specializing in research, development, and manufacturing of innovative therapeutics. Celltrion Branchburg, LLC, a subsidiary of Celltrion USA, operates a drug substance manufacturing facility in Branchburg, NJ. The Senior Scientist – QC (Responsible Scientist) performs holistic data reviews, interprets results, and releases data for QC Laboratories, while leading investigations and advising on technical and compliance practices across the network.

Responsibilities

• Perform in-depth second-tier holistic review, including data integrity and technical assessment of analytical testing associated with batch, stability, reference standard characterization, and production testing prior to release of individual test data and issuance of CoT.
• Conduct periodic reviews of method performance within QC Laboratories, including practice matches procedure and simplification support.
• Act as Qualified Lead Investigator to support QC on minor and moderate investigations.
• Author, review, and approve technical protocols, reports, and risk assessments; may support Annual Product Review, Annual Report, and YBPR.
• Support analytical monitoring, compliance, and campaign readiness for specific products.
• Interact with business partners to communicate and resolve QC compliance-related issues; participate as a core member of QC process teams.
• Manage site reference standards and assay controls program (if applicable).
• Perform routine data trending review and share across relevant teams within and outside the department.
• Technical reviewer of Analytical Investigations and advisor on test plans.
• Work with Regulatory Affairs to provide information and data supporting regulatory submissions; support and participate in regulatory inspections and commitments.
• Participate in method transfer activities, including advising on validation strategies and technical review of reports.
• Evaluate and recommend new technologies for the QC Laboratories.
• Support equipment evaluation and qualification studies.
• Perform routine safety walkthroughs in the QC area.

Requirements

• Strong problem-solving skills with experience in Root Cause Analysis.
• Skilled in authoring technical documents.
• Demonstrated proficiency in complex laboratory analysis, including bioassays, chromatographic, spectroscopic, and/or microbial assays.
• Strong quality and safety mindset.
• Understanding of compliance requirements and regulatory expectations.
• Strong oral and written communication skills.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Biology, Microbiology, or equivalent experience.
• 3–5 years of relevant experience in a GMP (analytical or microbiology) environment.

Preferred Skills

• Experience with a broad range of analytical techniques applicable to monoclonal antibodies.
• Knowledge of ICH guidelines applicable to biotech drug substance.
• Experience in regulatory submissions and analytical method validation.
• Strong statistical and technical writing skills.

Benefits

• Paid time off (holidays, vacation, and additional leave).
• Medical, dental, and vision insurance.
• Life insurance.
• Company-matched retirement savings plan.
• Wellness programs.
• Short- and long-term disability benefits.

Pay

The anticipated compensation range is $87,000 – $147,000, with placement based on experience, skills, internal equity, and market considerations.

Schedule

• This role may require up to 10% travel, on-call availability, and may involve shift work.
• Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.