Director, Formulation and Drug Product Development

Benefits

Parental leave

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Non-birth-parent leave

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Family-building benefits

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• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

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Relocation assistance

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Childcare support

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Learning budget

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Verification

Not verified last checked Jun 13, 2026

Salary

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401(k) match

Listed Source: SMALL_EMPLR_CONTRIB_INCOME_AMT. source Last checked Jun 13, 2026.

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Market context

Median wage (BLS OEWS)

$116,543 national median

Projected growth (BLS Employment Projections)

+9.8% - Much faster than average

Matched to SOC 15-1252 - Software Engineering aggregate by role bucket.

Source: U.S. Bureau of Labor Statistics, OEWS, May 2024 and Employment Projections, 2024-2034.

Schedule

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Weekend work

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Application

Cover letter

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Assessment

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Deadline

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Where they hire

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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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