Director, CMC – Formulations
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Job Description
Director of CMC - Formulations overseeing drug product formulations to support Codera’s development programs. Collaborating with internal departments on chemistry, manufacturing, and controls strategies.
Responsibilities:
- Assist with the design and evaluation of drug product formulations, primarily small molecule formulations, to achieve specific pharmacokinetic (PK) goals
- Contribute to CMC and development strategy
- Manage relationships with various contract development and manufacturing organizations (CDMOs), analytical labs and contract research organizations (CROs)
- Assist with the clinical supply logistics
- Prepare, analyze and interpret analytical data that integrate into regulatory and intellectual property (IP) documents
- Draft, edit and review sections of regulatory and IP documents
- Provide scientific input for analytical protocols and study reports
- Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence
- Research CMC and formulation topics to support Tang Capital’s investments
- Participate in business development activities, as requested
Requirements:
- Bachelor’s degree or higher in life sciences or related discipline required
- Master’s degree preferred
- Minimum of 5 years in relevant pharmaceutical industry work experience required
- Experience with small molecule formulations required
- Experience with biologics formulations preferred
- Experience working with CDMOs and analytical labs
- Experience with one or more of the following drug product formulation strategies: modified/delayed release, fixed-dose combinations, spray-dried dispersions
- Experience with a wide range of excipients and formulation technologies
- Experience with formulations for oral, subcutaneous and/or inhaled delivery
- Ability to research, synthesize and summarize complex CMC topics
- Experience writing and/or reviewing regulatory documents, including Investigational New Drug (IND)/New Drug Application (NDA) sections
- Ability to effectively organize and manage multiple assignments with challenging timelines from project start-up through submission
- Excellent knowledge of Food and Drug Administration (FDA) and International Council for Harmonisation (ICH) regulations and Good Manufacturing Practices (GMP)
- Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas
- Ability to establish and maintain collaborative working relationships with internal and external stakeholders.
Benefits:
- employer sponsored insurance plans including medical, dental and vision coverage
- generous paid time off
- retirement plan options
- additional wellness and professional development programs
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