Sr. Scientist - Bioassay

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.

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.
• Aid 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 efficiently 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 3–5 years of relevant Bioassay experience; or Bachelor’s degree with 5–7 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.

Pay

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.

Benefits

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