Director Bioassay Scientist Jobs (NOW HIRING)

Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics. We are committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. We have been at the forefront of biotherapeutic development uncovering new ways of targeting the drivers of disease by creating next-generation biologics and small molecule products.

Celltrion Branchburg, LLC is a subsidiary of Celltrion USA, established in 2025 following Celltrion USA’s acquisition of Eli Lilly’s drug substance (DS) manufacturing facility located in Branchburg. By linking robust local manufacturing capabilities with an existing direct sales network, we aim to generate greater synergies across our operations. Looking ahead, we also anticipate expanding into the global contract manufacturing organization (CMO) sector.

Position Brand Description:

We are seeking a highly motivated Scientist – Bioassay to join our Quality Control organization. The successful candidate will perform complex cell-based and biochemical bioassays supporting commercial product release, stability testing, method transfers, validation, and lifecycle management in a GMP-regulated environment. This role requires strong technical expertise, scientific problem-solving skills, and the ability to lead laboratory investigations while ensuring compliance with global regulatory requirements.

Key Responsibilities

• Perform routine and non-routine bioassay testing using cell-based and ligand-binding assays like ELISA, qPCR, Cell based Potency assay, cell viability assays, and enzyme activity assays as applicable.
• Deliver high-quality bioassay results with minimal errors.
• Ensure accurate documentation following ALCOA+ data integrity principles.
• Review and interpret assay results.
• Trend assay performance and identify shifts in assay variability.
• Prepare technical reports and laboratory documentation.
• Maintain laboratory notebooks and electronic records in compliance with GMP.
• Support assay qualification, validation, verification, and method transfers.
• Participate in assay optimization and continuous improvement initiatives.
• Assist in implementation of new technologies and automation.
• Lead laboratory investigations involving OOS, OOT, deviations, and atypical results within established timelines.
• Perform root cause analysis using scientific and statistical approaches.
• Develop and implement effective CAPAs.
• Ensure compliance with FDA, EMA, ICH, USP, and internal quality requirements.
• Support regulatory inspections and audits.
• Maintain inspection-ready documentation.
• Utilize LIMS, Nugenesis, SoftMax Pro, electronic laboratory notebooks (ELN), and laboratory execution systems.
• Partner and work efficient with cross functional teams.
• Support technology transfer activities for new products.
• Participate in project teams and continuous improvement initiatives.
• Train and mentor analysts.
• Develop SOPs and laboratory procedures.
• Promote a culture of scientific excellence and operational efficiency.

Required Qualifications

Education

• Master’s degree in biology, Microbiology, Biochemistry, Biotechnology, Immunology, Pharmaceutical Sciences, or related field with 5–7 years of relevant Bioassay experience; or
• Bachelor’s degree with 7–10 years of relevant GMP laboratory experience in Bioassay.

Preferred Skills

• Strong understanding of assay variability and bioassay statistics.
• Experience with method validation and technology transfer.
• Experience with electronic quality systems (Track Wise, Veeva, SuccessFactors, etc.).
• Excellent technical writing and presentation skills.
• Strong problem-solving and root cause analysis capabilities.
• Effective communication and collaboration across multidisciplinary teams.

This role is exempt and the anticipated compensation for this role is $87,000 - $147,000.

This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.