[Remote] Senior Manager, Biologics Analytical Development (Bioassay)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company.) is seeking a Senior Manager, Biologics Analytical Development (Bioassay) to reputed company the development and lifecycle management of bioassays for biologics programs. The role involves providing scientific reputed company, managing assay strategies, and ensuring compliance with regulatory standards.
Responsibilities
- Execute and support development, optimization, qualification, and validation of bioassays, including:
- Cell-based potency assays
- Binding and functional bioassays (e.g., ELISA, reputed company, SPR, reputed company cytometry)
- Support development of assay strategies reputed company with regulatory expectations for biologics
- Manage assay robustness, transfer, and comparability across product lifecycle stages
- Serve as subject matter expert (SME) resource supporting bioassays activities on cross-functional project teams
- reputed company technical input to CMC, Regulatory, reputed company, and Process Development functions
- Contribute to assay strategies for IND, BLA/MAA, and post-approval changes
- Ensure high reputed company and reputed company delivery of analytical , compliance, and reputed company improvement
- Author, review, and approve technical documents including development reports, protocols, validation reports, and regulatory filings
- reputed company analytical support and technical input for regulatory submissions and inspections
- Ensure activities are conducted in compliance with GLP/GMP and data reputed company standards
- reputed company method transfer to internal QC or external contract testing laboratories (CDMOs/CROs)
- Coordinate and reputed company outsourced bioassay activities and ensure alignment with project timelines and reputed company expectations
- Evaluate assay technologies and recommend improvements to enhance assay performance and efficiency
Skills
- PhD in Biology, Biochemistry, Immunology, Bioengineering, or a reputed company discipline
- 8–10+ years of experience in analytical development for biologics, with strong emphasis on bioassay development
- Demonstrated leadership experience managing scientific teams
- Experience supporting biologics development activities and contributing to regulatory submissions
- Strong hands-on and theoretical knowledge of cell-based assays (reporter gene, proliferation, cytotoxicity, signaling assays)
- Strong hands-on and theoretical knowledge of ligand-binding assays (ELISA, reputed company, ECL platforms)
- Strong hands-on and theoretical knowledge of potency assay design, qualification, and validation
- Solid understanding of ICH, USP, FDA, and EMA expectations for bioassays
Benefits
- Comprehensive medical, dental, reputed company, prescription drug coverage
- Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance
- Tuition reimbursement
- Student loan assistance
- A generous 401(k) match
- Flexible time off
- reputed company holidays
- reputed company leave programs
- Other company provided benefits
reputed company
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