Senior Director, Drug Product CMC — Formulation Leader

Centessa Pharmaceuticals; Boston (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Centessa Pharmaceuticals is seeking a Senior Director of Drug Product within the CMC group to lead nonclinical and clinical formulation development for small molecule drug candidates supporting Phase I-III studies.

You will oversee external CROs/CDMOs for characterization, pre-formulation, stability, and formulation across oral, subcutaneous, and intravenous routes; coordinate shipments and regulatory documentation for IND/CTA submissions; and provide CMC input at cross-functional meetings.

Qualifications

• PhD in Chemistry, Pharmaceutical Sciences, or related field.
• 10+ years in drug product/formulation development with expertise in poorly soluble compounds, dosage forms, and cGMP.
• Proficiency in analytical techniques such as HPLC, XRPD, DSC.
• Experience managing external partners and leading multiple programs.

Responsibilities

• Manage external CROs/CDMOs for characterization, pre-formulation, stability, and formulation of oral, subcutaneous, and intravenous drugs.
• Oversee protocol and report review.
• Provide CMC input at cross-functional meetings.
• Coordinate shipments and support regulatory documentation for IND/CTA submissions.

Skills

HPLC

XRPD

DSC

External CRO/CDMO management

Cross-functional leadership

Education

Ph.D. in Chemistry, Pharmaceutical Sciences, or related field

Job description

Centessa Pharmaceuticals is seeking a Senior Director of Drug Product within the CMC group to lead nonclinical and clinical formulation development for small molecule drug candidates supporting Phase I-III studies.

You will oversee external CROs/CDMOs for characterization, pre-formulation, stability, and formulation across oral, subcutaneous, and intravenous routes; coordinate shipments and regulatory documentation for IND/CTA submissions; and provide CMC input at cross-functional meetings.