Director, Formulation and Drug Product Development
Bicara Therapeutics Inc - Boston, MA, United States
Posted May 8, 2026
Benefits
- Parental leave
- Not verified
- Non-birth-parent leave
- Not verified
- Family-building benefits
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- Fertility benefits: Not verified
- Adoption assistance: Not verified
- Surrogacy assistance: Not verified
- Mental health support
- Not verified
- Relocation assistance
- Not verified
- Childcare support
- Not verified
- Learning budget
- Not verified
- Verification
- Not verified checked Jun 13, 2026
- Salary
- Not verified
- 401(k) match
- Reported from DOL Form 5500 industry filing (not employer-specific)
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Market context
- U.S. role benchmark (BLS OEWS)
- $102,662 U.S. median for this role
- Projected growth (BLS Employment Projections)
- +5.4% - Faster than average
Matched to SOC 11-1021 - Product Management aggregate by role bucket.
Source: U.S. Bureau of Labor Statistics, OEWS, May 2024 and Employment Projections, 2024-2034.
Schedule
- Shift type
- Not verified
- Weekend work
- Not verified
Company
Application
- Cover letter
- Not verified
- Assessment
- Not verified
- Deadline
- Not stated
Where they hire
State eligibility is not yet verified.
About this role
Director, Formulation and Drug Product Development Boston, MA, United States Position Overview Bicara Therapeutics is seeking a Director, Formulation and Drug Product Development who will lead the formulation and process development for complex biologics, with a strong emphasis on bispecifics, and fusion proteins, progressing into pivotal studies and commercial readiness. This role oversees drug product control strategy, process validation, and BLA/MMA submissions. The ideal candidate will bring expertise in late-stage development and establishment of drug product control strategies for bispecifics and fusion proteins including experience with Liguid/Lyo process development strategies, and high concentration formulation development. Responsibilities - Develop drug product development strategies through internal/external partnerships and product integration into drug/device combination products. - Oversee, scale-up, and characterize drug product manufacturing processes, including sterile filtration, filling/finish processes, and lyophilization - Oversee drug product development activities, ensuring successful tech transfer, characterization, and process validation - Serve as a subject matter expert on high concentration formulation development with experience in, control of aggregation, viscosity, and sub-visible particles - Provide technical guidance during investigations at CMOs/CROs and review technical development documents - Develop regulatory strategies and draft regulatory submissions including INDs, IMPDs, BLAs, and MAAs - 20-25% travel in support of manufacturing and development activities at CDMOs. - Collaborate with cross-functional teams, including analytical development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and success. Qualifications - M.S. with 12+ years or a Ph.D. in biochemical engineering, chemical engineering, biochemistry, or pharmaceutical sciences, with at least 8+ years of experience in an
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