Senior Director, Analytical Sciences

Bicara Therapeutics • Boston, MA

2d • Hybrid

About The Position

The Senior Director, Analytical Sciences will provide late-stage analytical leadership for complex biologics, with a strong emphasis on bispecific Antibodies, multispecifics, and fusion proteins, progressing into pivotal studies and commercial readiness. This role oversees analytical control strategy, PPQ support, method lifecycle management, and BLA/MMA submissions.

The ideal candidate will bring deep expertise in late-stage development and establishment of analytical control strategies for bispecifics and fusion proteins including experience with potency assay strategies, structural heterogeneity, and advanced characterization techniques.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

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 though 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

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 51-100 employees