About this role: Associate Director Drug Product
We are hiring a candidate who will participate in defining phase-appropriate strategies for small molecule drug product development. They will be responsible for oversight of day-to-day management of formulation activities at contract manufacturing organizations. This person will have the opportunity to work on the leading small molecule program in phase II/III.
- Lead drug product development activities and define phase-appropriate strategies for small molecule drug product development and manufacture.
- Participate in developing work scope plans and identifying and selecting drug product formulation development and manufacturing vendors with required capabilities.
- Manage activities, timelines, and budgets at CMO/CROs conducting manufacturing, testing, and packaging activities to meet overall project timelines.
- Monitor work performed by drug product CMOs, including reviews of protocols, reports, raw data, master and executed production records to ensure consistency with project and regulatory requirements and scientific integrity
- Troubleshoot formulation and manufacturing issues as needed.
- Participate in cross-functional development teams as needed.
- Prepare reports for management and identify issues to address with the cross-functional team.
- Author, review and approve GMP documents for clinical supply manufacturing.
- Prepare and review relevant sections of CMC regulatory submissions.
- Support any quality investigations or events and resolve them in a timely manner
- Degree in pharmaceutical sciences or relevant scientific discipline; Ph.D. (preferred) in relevant discipline and 8+ years relevant work experience OR B.S./M.S. in relevant discipline and 12+ years relevant work experience
- Small molecule drug product experience required. Experience in designing and developing solid and liquid oral formulations (such as IR, MR, ODTs) and associated processes for small molecules in support of clinical and preclinical studies.
- Pediatric formulation development experience a plus.
- Experience in designing and optimizing manufacturing processes for oral drug products
- Prior experience managing outsourced development and manufacturing
- In-depth knowledge of pharmaceutical cGMPs, regulatory standards and guidance documents for all phases of drug development
- Able to manage multiple internal and external activities to meet timelines
- Excellent computer, documentation, and organizational skills
- Strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment.
- Strong communication skills, able to work independently and collaborate with key internal and external stakeholders.
- Experience working with cross functional teams (analytical, quality, regulatory, clinical supply, process chemistry etc.)
- Must be flexible in adapting to a changing work environment and offer solutions to program challenges.
- Business travel, domestic and international, to various company offices, CMOs, and partners as required.
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Brunel USA - Boston