Sr. Manager, Product Development

Job Description

The Senior Manager, Product Development will serve as the CMC and Technical Lead for Women's Health development programs, including long-acting implants and intrauterine systems. This role will lead product development, CMC strategy, manufacturing support, external partner execution, regulatory readiness, and ANDA submission activities.

Key Responsibilities

• Lead technical development activities for Women's Health products (i.e., implants and intrauterine systems).
• Develop and execute formulation, process development, scale-up, and manufacturing strategies.
• Drive scientific investigations, data interpretation, root-cause evaluation, and technical decision-making.
• Support programs through registration, validation, regulatory submission, and commercialization readiness.
• Develop and execute CMC strategies supporting ANDA and other applicable regulatory submissions.
• Author, review, and approve scientific reports, development reports, technical assessments, risk evaluations, and regulatory responses.
• Support FDA interactions, Controlled Correspondence submissions, information requests, and deficiency responses.
• Partner with Regulatory Affairs and Quality to maintain submission readiness and regulatory compliance.
• Lead the preparation, authoring, review, compilation, and readiness assessment of ANDA CMC packages.
• Coordinate Module 3 documentation, pharmaceutical development reports, manufacturing process descriptions, comparability assessments, technical justifications, stability documentation, control strategy content, and device-related technical documentation.
• Identify CMC content and data gaps, assign closure actions, and drive documents through cross-functional review and approval.
• Support document finalization, regulatory publishing handoff, ANDA filing, and post-submission CMC responses.
• Provide technical leadership for engineering, pilot, exhibit, registration, and validation batch activities.
• Support investigations, deviations, change controls, CAPAs, manufacturing troubleshooting, and process optimization.
• Review manufacturing protocols, batch records, technical reports, and validation documentation.
• Collaborate with CMOs to ensure successful and compliant execution of development and registration activities.
• Serve as the technical liaison for CMOs, analytical laboratories, device suppliers, material suppliers, and development partners.
• Support governance reviews, Joint Steering Committees, vendor meetings, and program-management activities.
• Lead multidisciplinary teams and mentor scientists.

Qualification and Experience

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with 8+ years of relevant pharmaceutical development experience; or
• M.S. in a related scientific discipline with 12+ years of relevant pharmaceutical development experience.
• Demonstrated experience leading pharmaceutical product development and CMC activities for complex dosage forms or drug-device combination products.

Required Skills

• Complex generic or specialty pharmaceutical product development.
• CMC strategy, technical authoring, and regulatory submission support.
• Manufacturing process development, scale-up, technology transfer, and validation.
• Technical investigations, change controls, risk assessments, and scientific documentation.
• External partner, CMO, and vendor management.
• Cross-functional project leadership and effective communication with stakeholders.

Preferred Qualifications

• Long-acting implants, intrauterine systems, or sustained- and controlled-release technologies.
• Silicone-based drug delivery systems or polymer-based delivery systems.
• Drug-device combination product development and submission experience.
• IVRT or IVPT method strategy and data interpretation.
• Direct experience with FDA ANDA submissions and post-submission responses.
• Experience working with global development teams and external manufacturing partners.