Director – Manufacturing Sciences

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the technical point of contact on the sponsor side for manufacturing conducted at CDMOs, ensuring technical oversight.

• Provide on-site technical support (person-in-plant) during critical manufacturing processes, including engineering runs, process performance qualification, and implementation of process changes.

• Evaluate batch records, in-process data, deviations, and investigations generated by CDMOs with a sponsor perspective; offer technical assessments for deviations, CAPAs, and change controls.

• Develop and manage a continued process verification (CPV) / process monitoring program, analyzing process and analytical data across campaigns to ensure consistency, robustness, and ongoing comparability.

• Recognize opportunities for process improvements identified through monitoring and manufacturing experience, and assist in their development in collaboration with PD.

• Aid in the integration, consistency, and quality control of the CMC document set across PD and AD contributions, including reviewing and ensuring quality for Module 3 sections of INDs, CTAs, and IMPD updates, along with CDMO-generated content.

• Review and incorporate documents produced by CDMOs (such as tech transfer plans and reports, process validation documentation, and other technical summaries) into clear and defendable regulatory content.

• Draft and assist in finalizing responses to inquiries from health authorities and CMC-related questions.

• Ensure consistency, scientific accuracy, and regulatory compliance across all CMC documents for both programs.

• Coordinate and facilitate technology transfer activities as Phase 3 processes are defined and implemented at CDMOs.

• Assist in planning for manufacturing readiness and process performance qualification (PPQ), including authoring or contributing to PPQ protocols and reports from a sponsor-side technical perspective.

• Plan, execute, and analyze process and analytical comparability as drug substance processes transition between sites and scales, establishing defensible links from earlier clinical materials to Phase 3 and commercial supply.

• Contribute to the control strategy and justification of specifications for drug substance and drug product quality attributes in collaboration with AD and QC.

• Collaborate across PD, AD, Program Management, Quality, and Regulatory CMC to drive CMC deliverables forward.

• Support inspection and submission readiness from a CMC technical and documentation perspective.

⛳️ Requirements

• Required experience with monoclonal antibodies or complex biologics; experience with bispecific antibodies is highly advantageous.

• An advanced degree (MS or PhD) in biochemistry, chemistry, chemical/biochemical engineering, or a related life sciences field; a BS with significant relevant industry experience will also be considered.

• 10–12 years of CMC development experience for biologics, including practical expertise in drug substance process development, analytical development, or manufacturing science/technical operations.

• Strong understanding of ICH guidelines (Q6B, Q8, Q9, Q10, Q11) and GMP requirements applicable to biologics.

• Familiarity with control strategy principles and specification setting for biological products.

• Excellent technical judgment, with the ability to manage external technical relationships and influence cross-functionally without direct authority.

• Self-motivated and capable of working independently in a lean, fast-paced organization.

• Effective in both structured late-stage/commercial environments and in lean, earlier-phase or small-company settings.

• Willingness to travel to CDMO sites (approximately 10–20% of the time); international travel may be required.

🏝️ Benefits

• Medical, dental, and vision coverage for employees and their eligible dependents.

• 401(K) Retirement Plan with company matching.

• Company-paid long-term disability coverage.

• Company-paid life insurance and AD&D coverage.

• Optional life insurance and AD&D coverage available.

• Employee Assistance Program (EAP) provided.

• Paid holidays by the company.

• Vacation time offered.

• Paid sick leave included.

• Monthly telecommunications stipend.

• Reimbursement for work-from-home equipment.