Senior Biologist - Biotherapeutics Assay Leader

Mallinckrodt Pharmaceuticals; St. Louis (MO); Hybrid; USD 100,000 - 160,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

Keenova is seeking a Senior Biologist to lead development, validation, and transfer of cell-based potency and protein characterization assays for biotherapeutic products. You will work across functions to support assay modernization, product development, and regulatory activities.

The role requires leadership in mammalian cell culture, protein analysis, and regulatory understanding, with a strong emphasis on data integrity, collaboration, and scientific innovation.

Qualifications

• Ph.D. with 5+ years of relevant pharmaceutical or biotechnology industry experience.
• MS with 7+ years of relevant experience.
• BS with 10+ years of experience in pharma/biotech.

Responsibilities

• Lead development, validation, and transfer of biological assays for biotherapeutic products.
• Develop, optimize, and validate cell-based potency assays and protein characterization methods.
• Apply expertise in protein and gene expression analysis and related technologies.
• Provide technical troubleshooting and guidance to resolve analytical challenges.
• Collaborate with cross-functional teams and lead CROs to meet milestones.
• Prepare technical reports for internal and regulatory submissions.

Skills

Cell-based assays

Mammalian cell culture

Protein characterization

PCR/qPCR

Regulatory compliance

Data analysis

Scientific writing

CRO management

Education

Ph.D. in Biology or related

MS or BS with industry experience

Tools

ProteinSimple Jess

Peggy Sue

Western blotting

Job description

Keenova is seeking a Senior Biologist to lead development, validation, and transfer of cell-based potency and protein characterization assays for biotherapeutic products. You will work across functions to support assay modernization, product development, and regulatory activities.

The role requires leadership in mammalian cell culture, protein analysis, and regulatory understanding, with a strong emphasis on data integrity, collaboration, and scientific innovation.