Associate Director, Drug Product CMC

Scorpion Therapeutics; Indiana (PA); On-site; USD 180,000 - 235,000; Full time

Job summary

Lilly's CMC group seeks an Associate Director of Drug Product to lead early-stage formulation development for small molecule neurotherapeutics, addressing narcolepsy and hypersomnia.

You will oversee nonclinical formulation programs, manage CROs/CDMOs, guide physiochemical characterization, design formulations (oral, subcutaneous, IV), and coordinate with discovery, clinical, and regulatory teams to prepare IND filings.

Qualifications

• BS/MS in Pharmaceutical Sciences or related field.
• 7+ years in small molecule formulation development.
• Experience supporting Phase I-III programs.
• Experience with poorly soluble compounds.
• Experience managing external vendors (CDMOs) preferred.

Responsibilities

• Oversee nonclinical formulation development.
• Manage CROs and CDMOs.
• Guide physiochemical characterization and formulation design.
• Support clinical formulation projects.
• Prepare regulatory documentation for IND submissions.

Skills

Project management

Analytical techniques

Education

BS/MS in Pharmaceutical Sciences or related

PhD (preferred)

Tools

HPLC

XRPD

DSC

TGA

DVS

Job description

Role

Associate Director of Drug Product in Lilly's CMC group, supporting early-stage development of small molecule neurotherapeutics targeting sleep-wake disorders, including narcolepsy and hypersomnia.

Responsibilities

oversee nonclinical formulation development, manage CROs and CDMOs, guide physiochemical characterization, design formulations (oral, subcutaneous, IV), and support clinical formulation projects; collaborate across discovery, nonclinical, clinical, and regulatory teams; prepare regulatory documentation for IND submissions.

Requirements

BS/MS in Pharmaceutical Sciences or related; 7+ years in small molecule formulation development, with experience supporting Phase I-III programs, expertise in poorly soluble compounds, and proficiency with analytical techniques (HPLC, XRPD, DSC, TGA, DVS). Preferred: PhD, strong project management, strategic problem-solving skills, and experience managing external vendors.

High Value

small molecule, early-phase clinical development, nonclinical and clinical formulation, cGMP knowledge, cross-functional collaboration.

Work setup

US-based role with domestic and international travel (~5-10%).