A bit about us:
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.
Why join us?
- Medical, Dental, Vision!
- 401k!
- Paid vacation and Holidays
- R&D Environment
- Collaborative Team!
Job Details
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:
DUTIES & RESPONSIBILITIES:
EDUCATION & EXPERIENCE:
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
- 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.
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy