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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