Senior Director, Analytical Sciences
Bicara Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • United States
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Salary
💰 $255,000 - $300,000 per year
Job Level
About the role
- Provide strategic and scientific leadership for the Analytical Sciences function, ensuring scientific excellence and regulatory compliance.
- Lead late-stage analytical development, method transfer, qualification, validation, and commercial testing strategy.
- Oversee pivotal BLA-enabling analytical development deliverables for late-stage programs.
- Provide technical guidance during investigations at CMOs/CROs and review technical development documents.
- Define and justify commercial control strategies, specifications, and acceptance criteria for complex modalities.
- Develop and defend comparability strategies for process changes, scale-up, PPQ support, and post-approval changes, including structure–function correlation.
- Lead, mentor and develop high-performing analytical sciences teams.
- Provide analytical input and leadership for regulatory filings and responses to health authority questions.
- 20-25% travel in support of manufacturing and development activities at CDMOs.
- Collaborate with cross-functional teams, including process development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and success.
Requirements
- Ph.D. in biochemical engineering, chemical engineering, biochemistry, or pharmaceutical sciences, with at least 12+ years of experience in an industrial setting.
- Candidates with a B.S. and 20+ years’ experience or M.S. and 18+ years’ experience may also be considered.
- Prior experience in leading analytics through successful BLA/MAA approvals.
- Extensive experience in developing, qualifying, and validating biophysical, and biochemical test methods for protein-based biotherapeutics.
- Experience in establishing specifications for product release and stability studies, and establishing a commercial analytical control strategy.
- Experience in managing and working with global teams and external CDMO’s.
- Knowledge of Quality by Design principles, cGMP, and CMC requirements for regulatory filings globally, especially in the US and Europe.
- Strong writing and verbal communication skills, and effectiveness in communicating with interdisciplinary and cross-functional teams.
- Understanding of FDA, EMA, ICH guidelines associated with release, stability, and characterization assays.
- Proven experience with global regulatory submission and inspections.
- Experience in defining strategy for late-stage biologics drug development.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analytical developmentmethod transferqualificationvalidationcommercial testing strategybiophysical test methodsbiochemical test methodsspecifications for product releasestability studiescommercial analytical control strategy
Soft Skills
leadershipmentoringcommunicationcollaborationstrategic thinkingproblem-solvinginterpersonal skillsteam developmenttechnical guidancecross-functional teamwork
Certifications
Ph.D. in biochemical engineeringPh.D. in chemical engineeringPh.D. in biochemistryPh.D. in pharmaceutical sciences