Director – Manufacturing Sciences

Angitia Biopharmaceuticals

Director of Manufacturing Sciences overseeing technical and operational work on bispecific monoclonal antibody development. Working with cross-functional teams and external manufacturing partners in a remote capacity with travel.

Posted 6/23/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $210,000 - $265,000 per yearWebsite

About the role

Key responsibilities & impact

Serve as a sponsor-side technical point of contact for manufacturing executed at CDMOs, providing technical oversight
Provide on-site technical presence (person-in-plant) during key manufacturing activities — engineering runs, process performance qualification, and process change implementation
Review CDMO-generated batch records, in-process data, deviations, and investigations with a sponsor lens; contribute technical assessments for deviations, CAPAs, and change controls
Establish and own a continued process verification (CPV) / process monitoring program, trending process and analytical data across campaigns to monitor consistency, robustness, and ongoing comparability
Identify process improvement opportunities arising from this monitoring and from manufacturing experience, and support their development in partnership with PD
Support the integration, consistency, and quality control of the CMC document set across PD and AD inputs — including Module 3 sections of INDs, CTAs, and IMPD updates, with review and QC of CDMO-generated content
Review and integrate CDMO-generated documents (e.g., tech transfer plans and reports, process validation documentation, and other technical summaries) into clear, defensible regulatory content
Draft and help finalize responses to health authority RFIs and CMC questions
Ensure consistency, scientific accuracy, and regulatory alignment across all CMC documents for both programs
Coordinate and support technology transfer activities as the Phase 3 processes are defined and implemented at CDMOs
Support manufacturing readiness and process performance qualification (PPQ) planning, and author or contribute to PPQ protocols and reports from a sponsor-side technical standpoint
Plan, execute, and interpret process and analytical comparability as drug substance processes move between sites and scales, building defensible bridges from earlier clinical material to Phase 3 and commercial supply
Contribute to control strategy and specification justification for drug substance and drug product quality attributes, in partnership with AD and QC
Partner across PD, AD, Program Management, Quality, and Regulatory CMC to advance CMC deliverables
Support inspection and submission readiness from a CMC technical and documentation standpoint

Requirements

What you’ll need

Experience with monoclonal antibodies or complex biologics required; bispecific antibody experience a strong plus
Advanced degree (MS or PhD) in biochemistry, chemistry, chemical/biochemical engineering, or a related life sciences discipline; BS with extensive relevant industry experience considered
10–12 years of CMC development experience for biologics, including hands-on background in drug substance process development, analytical development, or manufacturing science / technical operations
Solid command of ICH guidelines (Q6B, Q8, Q9, Q10, Q11) and GMP requirements for biologics
Familiarity with control strategy principles and specification setting for biological products
Strong technical judgment, with the ability to manage external technical relationships and to influence cross-functionally without direct authority
Self-directed and effective operating with autonomy in a lean, fast-moving organization
Effective in both structured late-stage / commercial environments and lean, earlier-phase or small-company settings
Willingness to travel to CDMO sites (~10–20% of time); international travel likely.

Benefits

Comp & perks

Medical, dental, and vision coverage for employees and their eligible dependents
401(K) Retirement Plan with Company match
Company paid Long Term Disability Coverage
Company-paid life Insurance & AD&D Coverage
Voluntary Life Insurance & AD&D Coverage
Employee Assistance Program (EAP)
Company-paid Holidays
Vacation
Paid Sick Leave
Telecommunication Monthly Stipend
Work-From-Home Equipment Reimbursement

ATS Keywords

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Hard Skills & Tools

monoclonal antibodiescomplex biologicsdrug substance process developmentanalytical developmentmanufacturing sciencetechnical operationsICH guidelinesGMP requirementscontrol strategy principlesspecification setting

Soft Skills

technical judgmentmanage external technical relationshipsinfluence cross-functionallyself-directedeffective operating with autonomyadaptability in structured environmentsadaptability in lean environmentsstrong communicationcollaborationproblem-solving

Certifications

MS in biochemistryPhD in biochemistrychemical engineeringbiochemical engineeringrelated life sciences discipline