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AD/Director Formulations CMC
2 months ago
Associate Director/Director CMC Formulations
Our client is a small, dynamic pharma company focused on cutting-edge oncology and immunology treatments. As part of a growing and innovative team, you’ll have the opportunity to make a significant impact on the development of life-changing therapies.
They are seeking an experienced Associate Director/Director of Formulation to lead the formulation development of solid oral products. The role requires hands-on expertise in both early-stage and later-stage development, with strong experience in external manufacturing partnerships. This is a unique opportunity to contribute to the development of breakthrough therapies in oncology and immunology. This role will be on a flexible hybrid basis 2-3 days a week onsite.
Key Responsibilities:
- Lead the formulation development of solid oral products, advancing projects from early-phase development through late-stage and commercialization.
- Work closely with external manufacturing partners on tech transfer, scale-up, and commercial production, ensuring alignment with project timelines and quality standards.
- Author and review CMC sections for regulatory submissions, including IND, NDA, and BLA filings.
- Collaborate across functional teams, including R&D, quality, manufacturing, and regulatory affairs, to drive project success.
- Reporting into the SVP of CMC, helping them build the Formulations team as they continue to expand.
Requirements:
- Degree in a relevant field and over 8 years experience in pharma industry
- Proven experience in solid oral dosage form development in both early and late stages.
- Hands-on experience authoring and reviewing CMC submission sections.
- Strong background in working with external manufacturing partners for tech transfer and production.
- Experience in oncology or immunology product development is a plus.
Apply today or send an email to rbanton@barringtonjames.com
