Associate Director/Director, Formulation Development
Location: Greater Boston Area
Salary: $225,000-$240,000
An innovative Biotechnology firm is looking to hire an Associate Director/Director of Formulation Development for their pharmaceutical products. This person is responsible for developing phase appropriate formulations for preclinical and clinical use. They will work closely with external partners and cross functional groups through all phases of development.
Responsibilities:
- Provide leadership and oversight for various formulation activities including (formulation development, process development, analytical development, GMP manufacturing)
- Collaborate cross functionally with CMC, DMPK, Quality, Regulatory, Legal, and clinical groups to advance formulation plans
- Timely and effectively manage objectives, time lines, milestones, and budgets across all formulation and manufacturing activities
- Lead and Identify external CDMO organizations to achieve company objectives
Requirements:
- Ph.D. in pharmaceutical sciences or related field, 8+ years of pharmaceutical experience with a solid background in formulation activities
- Expertise across a wide range of dosage forms and knowledge of regulatory filings including (INDs, IMPDs, NDAs)
- Ability to maintain strong working relationships with a variety of stakeholders
- Understanding of GMP requirements, specifically early stage
- Willingness to travel to meetings or client sites (internationally or domestically)
