Evofem Biosciences, Inc., (NASDAQ: EVFM) is a commercial-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. Evofem Biosciences aims to advance the lives of women by developing innovative solutions, such as woman-controlled contraception and potential protection from certain sexually transmitted infections (STIs). The Company's first commercial product, Phexxi™ (lactic acid, citric acid and potassium bitartrate), is approved in the United States for the prevention of pregnancy. The Company is advancing EVO100 for the prevention of urogenital transmission of both Chlamydia trachomatis infection (chlamydia) and Neisseria gonorrhoeae infection (gonorrhea) in women.
We are a growing team based in San Diego, CA. Our sole purpose is also our soul purpose: to improve the lives of women. We are committed to discovering and developing innovative healthcare solutions that put women first.
Director, Product Development
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.
- 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.
- Must be detailed oriented, possess excellent time management skills, be well organized, able to contribute independently and display a professional demeanor.
- Must possess excellent communication and technical writing skills, strong interpersonal skills, and ability to work with others in a positive and collaborative manner; able to communicate with sense of urgency to internal and external customers.
- Excellent experimental design, trouble shooting and quantitative data analysis skills.
- Ability to lead, supervise and coordinate the work of external consultants and vendors and ensuring adherence to established timelines.
Supervisory Responsibility: This position oversees and coordinates the work of relevant consultants and external vendors.
Education and Qualifications:
- 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.
Travel: Up to 25%.
Evofem Biosciences provides a competitive salary and generous benefits package including medical, dental, vision coverage, 401k, paid vacation and Holidays.E/O/E-including disability and vets.*No agencies please*
If you need a reasonable accommodation to complete the application process, due to a disability, please contact Human Resources at firstname.lastname@example.org.