Disrupt Pain Without Opioids. While other treatments dull pain, Latigo’s solutions target the source of pain before it reaches the central nervous system. The result is healing without dependence, and relief that can help restore quality of life. Backed by 5AM Ventures.
About the role
We are seeking an experienced and execution-oriented Associate Director / Director, Drug Product Development to lead drug product activities for small-molecule programs from candidate selection through clinical development, registration, and commercialization. This individual will provide technical leadership for formulation and process development, clinical and registration supply, technology transfer, process validation, regulatory submissions, and launch readiness. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- PhD. or MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline with at least 10-15 years of relevant pharmaceutical or biotechnology industry experience
- Demonstrated ability to lead drug product activities for one or more development programs and to work effectively on cross-functional CMC or program teams
- Experience authoring or critically reviewing drug product sections of regulatory submissions, particularly Module 3.2.P, and supporting responses to health-authority questions
- Strong expertise in oral solid dosage forms. Experience with parenteral formulations, sterile product development, or associated manufacturing controls is preferred
- Experience with amorphous or other enabling formulation technologies for low-solubility compounds, such as solid dispersions, spray drying, hot-melt extrusion, or comparable approaches
- Strong working knowledge of Quality by Design, pharmaceutical development risk management, cGMP requirements, and relevant global/ICH quality guidance
More about this role
Job Title: Associate Director/Director, Drug Product Development
We are seeking an experienced and execution-oriented Associate Director / Director, Drug Product Development to lead drug product activities for small-molecule programs from candidate selection through clinical development, registration, and commercialization. This individual will provide technical leadership for formulation and process development, clinical and registration supply, technology transfer, process validation, regulatory submissions, and launch readiness. The role requires strong expertise in oral solid dosage forms and practical experience with enabling or amorphous formulation technologies for poorly soluble compounds. Experience with parenteral dosage forms is desirable. The successful candidate will work effectively across internal functions and external development and manufacturing partners in a growing biotechnology environment.
- Lead drug product development strategy and execution for assigned small-molecule programs, with responsibility spanning formulation and process development, clinical supply, technology transfer, registration-enabling activities, and commercialization.
- Serve as the drug...
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