What are the responsibilities and job description for the Associate Director, Drug Product Development/CMC position at Latigo Bio?
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.
Postion Description:
Latigo is searching for Associate Director of Drug Product Development/CMC. The position will contribute to the formulation, drug product development and GMP drug product manufacturing for Latigo’s small molecule clinical pipeline. The successful candidate will manage and collaborate with contract development and manufacturing vendors and ensure timely delivery of drug product in support of IND enabling programs and ongoing clinical development programs. The CMC Associate Director 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:
- Lead CDMOs/CROs in conduct of pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing for small molecule drug products
- Coordinate with Clinical Operations and Program Teams to ensure that drug supplies are available on-time for support of clinical studies.
- Provide critical review of manufacturing batch records and integrate results into CMC regulatory filings
- Develop target drug product profiles and specifications, set goals and maintain timelines for CMO manufacturing activities
- Drive continuous improvements in the drug product development process through technological innovation and problem-solving.
- Provide critical pre- and post-review of manufacturing batch records and integrate results into CMC regulatory filings
- Author and review regulatory reports/documents such as IND filings, IND updates, product development reports, quality summary, master batch records and other key reports/documents
- Work with manager to create and communicate project strategy, plans and schedules that are aligned with company objectives and portfolio prioritization
- Communicate project status to project leaders to assist in driving decision making
Experience and Required Skills:
- PhD or MS degree in Pharmaceutical Sciences, Chemical Engineering or Chemistry preferred, and at least 8 years of hands-on experience in small molecule drug product development.
- Experience managing CDMO’s remotely.
- Strong understanding of ICH guidance and cGMP regulations and manufacturing
- Working knowledge of quality by design and risk management is strongly desired.
- Prior small molecule drug product development experience from pre-clinical to clinical phase.
- Late-stage development and commercialization experience is a plus
Additional Skills/Preferences:
- Ability to provide CMC Project/Portfollio management (MS Project or similar) highly desirable
- Familiarity with US and international regulatory CMC guidance and processes
- Prior experience filing INDs required; NDA experience highly desirable
- 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 $170,000 to $190,000
Salary : $170,000 - $190,000
