Associate Director, Drug Product Formulation & CMC

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 129,000 - 231,000; Full time

Job summary

Lilly, headquartered in Indianapolis, IN, seeks an Associate Director, Drug Product within the CMC group to lead nonclinical and clinical formulation development for small molecules, manage external partners, and ensure timely deliverables across Phase I–III programs.

You will oversee cross-functional teams, coordinate vendor activities domestically and internationally, and contribute to regulatory submissions while travel of 5–10% is anticipated.

Qualifications

• BS or MS in Pharmaceutical Sciences or a related scientific discipline required; PhD strongly preferred.
• 7+ years of experience in small molecule formulation development across oral, subcutaneous, and intravenous dosage forms.
• Deep understanding of formulation development and manufacturing for poorly soluble (BCS II/IV) small molecules.
• Strong knowledge of pharmaceutical and engineering principles for liquid and solid dosage forms at clinical and commercial scale.
• Proficiency with analytical and solid-state characterization techniques (HPLC/UPLC, XRPD, DSC, TGA, DVS).
• Experience managing external development partners (CROs, CDMOs, CMOs).
• Working knowledge of cGMP requirements and pharmaceutical development standards.
• Strong strategic, analytical, and problem-solving skills; ability to drive timely results.
• Excellent communication, interpersonal, and project leadership skills.

Responsibilities

• Manage external vendors (CROs/CDMOs) to execute studies and development activities.
• Design and develop nonclinical formulations for oral, subcutaneous, and IV delivery.
• Oversee stability and compatibility studies for nonclinical formulations.
• Support clinical formulation development of oral solid dosage forms.
• Author or review development and dose preparation protocols and reports.
• Review PK/PD and safety study data related to formulations.
• Represent CMC in cross-functional teams for development guidance.
• Coordinate shipments to CDMO/CRO sites for clinical supply.
• Prepare formulation documentation for regulatory submissions (IND/CTA).
• Collaborate with discovery, nonclinical, clinical, PM, legal, sourcing, supply chain and QA/regulatory teams.

Skills

7+ years experience

Formulation development

Analytical techniques

cGMP knowledge

Vendor management

Cross-functional collaboration

Project leadership

Communication

Travel willingness

Education

BS/MS in Pharmaceutical Sciences

PhD preferred

Tools

HPLC/UPLC

XRPD

DSC

TGA

DVS

Job description

Lilly, headquartered in Indianapolis, IN, seeks an Associate Director, Drug Product within the CMC group to lead nonclinical and clinical formulation development for small molecules, manage external partners, and ensure timely deliverables across Phase I–III programs.

You will oversee cross-functional teams, coordinate vendor activities domestically and internationally, and contribute to regulatory submissions while travel of 5–10% is anticipated.