Somerset, NJ Sr_ Manager, Product Development FL

Job description

Turn science into impact. Lead the CMC and technical strategy behind innovative Women’s Health products from development and scale-up through FDA submission and commercialization 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. The anticipated annual base salary range for this position in New Jersey is $100,000 to $130,000, plus a discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, the type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility Apply now » • Apply Now • Start applying with LinkedIn • Please wait... Find similar jobs: Lupin-United States Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. 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