Director, Formulation and Drug Product Development

Bicara Therapeutics

. Lead the formulation and process development for complex biologics .

Posted 5/9/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesLead💰 $216,000 - $252,000 per yearWebsite

About the role

Key responsibilities & impact

Lead the formulation and process development for complex biologics
Oversee drug product control strategy, process validation, and BLA/MMA submissions
Develop drug product development strategies through internal/external partnerships
Oversee, scale-up, and characterize drug product manufacturing processes
Ensure successful tech transfer, characterization, and process validation
Provide technical guidance during investigations at CMOs/CROs
Develop regulatory strategies and draft regulatory submissions
Collaborate with cross-functional teams to ensure seamless integration and success
20-25% travel in support of manufacturing and development activities

Requirements

What you’ll need

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 industrial setting
Formulation and drug product process development experience with complex biologics including bispecifics and fusion proteins
Experience in development and characterizing lyophilized drug product processes
Experience developing high concentration formulations preferred
Experience in authoring regulatory filings (INDs, IMPDs, BLAs, MAAs)
Experience in effectively managing cross functional teams
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 drug product development, characterization, and validation.
Experience in defining strategy for late-stage biologics drug development

Benefits

Comp & perks

Health insurance
Dental coverage
Vision coverage
Short-term and long-term incentives
Cash bonus
Equity incentive opportunities
Comprehensive benefits and wellness package

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

formulation developmentprocess developmentdrug product control strategyprocess validationBLA submissionsMMA submissionslyophilized drug product processeshigh concentration formulationsregulatory filingslate-stage biologics drug development

Soft Skills

technical guidancecross-functional collaborationteam managementstrong writing skillsverbal communication skills

Certifications

M.S. in biochemical engineeringM.S. in chemical engineeringM.S. in biochemistryM.S. in pharmaceutical sciencesPh.D. in biochemical engineeringPh.D. in chemical engineeringPh.D. in biochemistryPh.D. in pharmaceutical sciences