Job Title: Director/Senior Director Product Development
Job Number: 30952
Location: San Francisco, CA
The Director/Senior Director for Small Molecule Drug Substance Development will report directly to the Head of Pharmaceutical Sciences. This individual will be responsible for all company’s CMC projects in terms of chemical process development, scale-up, technology transfer and manufacturing. This individual will work independently to support drug substance development activities in contract development and manufacturing organizations (CDMOs).
- Establish chemical process development strategies based on project’s timelines.
- Manage and oversee the implementation of the chemical process development and optimization, drug substance for clinical supply and registration batch manufacturing, and validation activities at external contract development and manufacturing organizations (CDMOs) by following the FDA guidance and QbD principles in accordance with documented work plans and cGMP requirements to ensure on time delivery of drug substance.
- Oversee batch manufacturing, determine the best starting material and key intermediate strategy, and drug substance characterization. Establish the critical raw material attributes, controls and in-process control strategies.
- Review Master and Executed Batch Records, protocols and reports related to all GMP operations related to the drug substance production.
- Coordinate with Analytical Function for completing testing of new drug substance, help design stability studies on selected batches of substance in a timely manner.
- Monitor deviations and process changes; ensure appropriate technical and management visibility within the company and facilitate feedback and decisions to the CDMOs.
- Works collaboratively with Quality Assurance and Regulatory Affairs to ensure a high- level of cGMP compliance and ensure that FDA/ICH guidelines are followed when appropriate.
- Provide supporting documents for the IND/NDA and IMPD/MAA submissions as well as for the regulatory filings in the other regions of the world.
- Ph.D. in Organic Chemistry with 12+ years of experience in the Pharmaceutical or Biotech industry with a focus on small molecules drug substance development and manufacturing.
- A proven track record in developing and scaling up chemical processes for drug substance from pre-IND through late-stage development.
- Extensive hands-on experience in process development, clinical supply and registration batch manufacturing for a variety of drugs.
- Proficiency with drug substance physiochemical characterization including microscopy, X-ray diffraction, thermal analysis, solid-state NMR, moisture sorption, etc.
- Proficiency with Quality by Design (QbD) concepts and design of experiments (DoE).
- Familiarity with drug product physiochemical and mechanical characterization, and drug-excipient compatibility study.
- Experience in chemistry and process technologies by utilizing enabling pre-formulation approaches to enhance the bioavailability of BCS class 2 and 4 compounds.
- Familiarity with a contract manufacturing environment with an in-depth knowledge of operations for small molecule drug substance manufacturing.
- Experience as primary author of relevant sections of INDs and NDAs.
- Ability to effectively work independently in a team environment with the internal department including but not limited to the Drug Product, Analytical, Regulatory, and Quality Assurance Department in a fast-paced collaborative environment.
- Ability to effectively work with external CDMOs to meet the timelines while staying within approved budgets.
- Ability to travel up to 20% of the time.
- Other skills required:
- Strong leadership skills, demonstrated by the ability in leading large teams of individuals to successful outcomes.
- Ability to cultivate a strong internal culture designed around collaboration, feedback, motivation, and accountability.
- Strong communication and interpersonal skills.
- Demonstrated ability to work in fast pace, multi-tasking team environment while meeting deadlines.
- Highly skilled in leading change efforts and in building strong partnerships with business-line executives.
- Ability to summarize complex issues and problems into a concise report, focused on key findings and outcomes.
- Sets the example of team collaboration as well as clinical collaboration throughout other regions.
- Proficiency in developing communication strategies for a wide array of audiences that support strategic objectives.
- Ability to interact with clients and physician groups on program protocols and outcomes.