Senior Director, Drug Product CMC

Scorpion Therapeutics; Boston (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

Scorpion Therapeutics in Boston, MA is seeking a Senior Director of Drug Product within the CMC group to lead nonclinical and clinical formulation development for small molecule candidates supporting Phase I–III studies.

You will manage external CROs/CDMOs for characterization, pre-formulation, stability and dosage forms, review protocols and reports, and provide CMC input at cross-functional meetings while coordinating regulatory submissions for IND/CTA.

Qualifications

• PhD required in Chemistry, Pharmaceutical Sciences, or related field.
• 10+ years in drug product/formulation development with expertise in poorly soluble compounds and dosage forms.
• Proficiency with analytical techniques such as HPLC, XRPD, and 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 for development programs.
• Provide CMC input at cross-functional meetings.
• Coordinate shipments and support regulatory documentation for IND/CTA submissions.

Skills

HPLC

XRPD

DSC

Vendor management

Education

Ph.D. in Chemistry or Pharmaceutical Sciences

Tools

cGMP

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

Work Setup

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