We are a commercial-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health.

SUMMARY:
The Director of Product Developments is responsible for implementation of efficient systems and management of overall activities within the Product Developments group. This position is coordinating the effective delivery of data on GLP and GMP studies as well as managing the CMC sections of regulatory submissions. This position will also ensure consistent use of best and effective processes across the CMC team. The position will work closely with the heads of the TechOps, Supply Chain and Logistics, Quality Assurance and Clinical Affairs.

MUST HAVE:

• Synthetic Chemistry Experience

DUTIES & RESPONSIBILITIES:

• Represents the Product Development department on cross-functional teams for all projects.
• Selects CMOs/CROs and manages outsourced GLP/GMP studies within Product
• Development. This includes managing outsourced GLP/GMP studies within Product Development.
• Interacts with CMOs/CROs as well as internal inter-disciplines to ensure timely delivery of the analytical data.
• Plans and coordinates laboratory studies. This includes the stability testing of development compounds and formulations, formulation development support.
• Reviews and approves analytical data, technical protocols/reports, specifications and analytical methods.
• Summarizes experimental findings, reviews and interprets study results, assembles analytical data packages.
• Monitors, organizes and prioritizes activities and resources to increase efficiency on a regular basis.
• Develops and manages budgeting and budget execution with a focus on costs and margins.
• Implement strategies, resource planning and execution of department operations to meet corporate goals and department goals.
• Recruits, manages and mentors Product Developments staff, particularly with respect to new processes and procedures as well as changes in processes and systems.
• Monitor the performance of staff assigned to Product Development Operations and ensure that policies and procedures are followed consistently.
• Evaluates and leads implementation of new improved processes within Product Developments for delivering high quality CMC information to agreed timelines.
• Authors and reviews high top quality Regulatory documents for INDs, IMPDs, MAAs and NDA.
• Maintains up-to-date knowledge of applicable industry and regulatory guidelines and requirements.
• Authors and reviews SOPs

EDUCATION & EXPERIENCE:

• Ph.D. in Analytical Chemistry or related disciplines with 10+ years relevant industry experience, or MS with 12+ years of experience in the pharmaceutical/ biotechnology

industry.

• Working knowledge of GLP and cGMP requirements.
• Strong writing skills and experience in contributing to regulatory filings and CMOs/CROs management.
• Knowledge of regulatory guidance and requirements related to nonclinical development and CMC activities.
• Understand and adhere to GMP and GLP policies and procedures.