Title: Senior Manager, Chemical Development / CMC
Location: Thousand Oaks, CA or San Francisco, CA
Company Description:
Latigo Biotherapeutics, Inc. is a private, early-stage biotechnology company focused on discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes. Our mission is the development of novel therapies that transform the lives of patients. The company is headquartered in Thousand Oaks, CA and has a highly successful management team as well as an experienced Board of Directors. At Latigo, we value science, patient-focus, and innovation.
Position Description:
Latigo is searching for a Senior Manager of Chemical Development/CMC. Reporting to the Director of Drug Substance and Development, the Senior Manager will assist in the development and GMP drug substance manufacturing for Latigo’s small molecule clinical pipeline.
The successful candidate will manage the development and manufacturing of small molecule intermediates and active pharmaceutical ingredients at contract manufacturing organizations. The Senior Manager will partner with drug product and analytical team members to ensure timely delivery of active pharmaceutical ingredients (API) in support of both IND enabling programs and clinical development programs. The CMC Senior Manager will further provide written support for regulatory CMC filings. This individual will work collaboratively with other internal and external Pharmaceutical Sciences and Regulatory personnel on appropriate CMC-related reports and filings.
Primary Responsibilities:
- Drive continuous improvements in the drug substance process development through technological innovation and problem-solving
- Manage the synthesis of reference markers at CMOs/CROs
- Assist in the management of CMOs/CROs in conduct of API process development, process optimization, scale-up and clinical manufacturing
- Help to develop target drug substance profiles and specifications, set goals and maintain timelines for CMO manufacturing activities
- Provide critical pre- and post-review of manufacturing batch records and integrate results into CMC regulatory filings
- Manage and review deviation events and investigations in coordination with CMC counterparts, QA and regulatory team members
- Represent drug substance function in CMC teams and project meetings, and work closely with cross-functional teams to meet project timelines and goals
- Contribute to regulatory reports/documents such as IND filings, IND updates, product development reports, quality summary, master batch records and other key reports/documents
- Communicate project status to project leaders to assist in driving decision making
- Contribute to the building of CMC infrastructure and company culture
Experience and Required Skills:
- PhD or MS degree in Chemistry or Chemical Engineering, and at least 5 years of hands-on experience in small molecule drug development
- Strong understanding of organic synthesis and ability to direct and guide the work of CMOs
- Strong understanding of cGMP regulations and manufacturing
- Early-stage development of pre-clinical and clinical API’s experience is highly desirable
- Prior experience in managing either internal or external projects is a plus
Additional Skills/Preferences
- Familiarity with US and international regulatory CMC guidance and processes
- Prior experience filing INDs and NDA experience is a plus
- Strong team player with excellent written and verbal communication skills
- Excellent computer skills (e.g., Microsoft Office, Excel, Project)
- Strong organizational skills with attention to detail and ability to manage multiple projects at once
- Ability to work both independently and in a team focused environment
- Limited travel may be required (less than 20%)
Salary ranges from $124,000 to $155,000
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Last updated on Aug 29, 2024