Senior Director, Drug Product CMC

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

Role:

Senior Director of Drug Product within the CMC group, leading nonclinical and clinical formulation development for small molecule drug candidates supporting Phase I-III studies.

Responsibilities:

• manage external CROs/CDMOs for physiochemical 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

Requirements:

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


• 10+ years in drug product/formulation development, with expertise in poorly soluble compounds, dosage forms, and cGMP compliance


• proficiency in analytical techniques like HPLC, XRPD, DSC


• experience managing external partners and leading multiple programs

High-Value:

small molecules, Phase I-III, nonclinical/clinical formulation, cGMP, regulatory support, global vendor management.

WorkSetup:

US-based, with domestic and international travel; full-time, exempt.