Associate Director, Drug Product Technical Services (DPTS)

Wave Life Sciences; Lexington (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director of DPTS to oversee drug product validation for Wave's injectable assets in Phase 1-3, including formulation support, tech transfer, and regulatory documentation.

You will plan and execute DP formulation studies, oversee GMP manufacturing and tech transfer at CMO sites, author regulatory submission sections, manage CMO relationships, and ensure a reliable supply for clinical trials.

Qualifications

• Ph.D. or equivalent in Pharmaceutical Sciences, Chemistry, or Engineering.
• 8+ years in biopharma GMP environment with PPQ experience.
• Experience in DP formulation development, regulatory submissions, and managing CMO collaborations.

Responsibilities

• Plan and execute DP formulation studies and supervise GMP manufacturing and tech transfer at CMO sites.
• Author regulatory submission sections and manage CMO relationships to ensure clinical supply.

Skills

DP formulation development

Regulatory submissions

CMO collaborations

Education

Ph.D. in Pharmaceutical Sciences, Chemistry, or Engineering

Job description

Role

Associate Director of DPTS overseeing drug product validation for Wave's injectable assets in Phase 1-3 trials, including formulation support, tech transfer, and regulatory documentation.

Responsibilities

Plan and execute DP formulation studies, oversee GMP manufacturing and tech transfer at CMO sites, author regulatory submission sections, manage CMO relationships, and ensure supply for clinical trials.

Requirements

Ph.D. or equivalent in Pharmaceutical Sciences, Chemistry, or Engineering; 8+ years in biopharma GMP environment with PPQ experience; experience in DP formulation development, regulatory submissions, and managing CMO collaborations.

High Value

Biologics/oligonucleotides, injectable drug products, Phase 1-3 clinical development, GMP compliance, and regulatory documentation expertise.

Work Setup

Not specified; travel requirements not detailed.