(Associate) Director, Drug Product - CMC
$170,000–$195,000 year
On-siteBoston, Massachusetts, United States
Job Summary
Manage and guide external vendors, including CROs and CDMOs, to execute physiochemical characterization and pre-formulation studies for New Chemical Entities. Design and oversee execution of nonclinical formulation stability and compatibility studies for oral, subcutaneous, and intravenous drug candidates while supporting clinical formulation development of solid dosage forms as needed. Author, review, and approve development protocols and reports, coordinating shipments for nonclinical and clinical supply requirements and assisting with regulatory documentation for IND and CTA submissions. Represent CMC in cross-functional meetings to provide stability and supply guidance. This role requires a track record in small molecule formulation development, with occasional domestic and international vendor travel.
Required Qualifications
- BS or MS in Pharmaceutical Sciences or a related scientific discipline
- 10+ years of experience in small molecule formulation development, including support of nonclinical and clinical programs across oral, subcutaneous, and intravenous dosage forms
- Deep understanding of formulation development and manufacturing of poorly soluble (BCS Class II/IV) small molecule compounds for oral, subcutaneous, and intravenous delivery
- Strong knowledge of pharmaceutical and engineering principles related to liquid and solid dosage form development at clinical and commercial scale
- Proficiency with analytical and solid-state characterization techniques, including HPLC/UPLC, XRPD, DSC, TGA, DVS, and related methodologies
- Experience managing external development partners (CROs, CDMOs, CMOs) and coordinating pharmaceutical product development activities
- Working knowledge of cGMP requirements and pharmaceutical development standards
- Strong strategic, analytical, and problem-solving skills, with the ability to anticipate risks, develop contingency plans, and drive timely, high-quality results
- Excellent communication, interpersonal, and project leadership skills, with the ability to influence stakeholders, manage cross-functional and external relationships, and effectively communicate complex concepts to diverse audiences
- Highly organized, detail-oriented, and self-directed, with the ability to manage multiple priorities and perform effectively in a fast-paced, dynamic environment
- Willingness to travel domestically and internationally (5-10%)
Desired Qualifications
- PhD
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