Director – Manufacturing Sciences
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Job Description
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.
Responsibilities:
- 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:
- 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:
- 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
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