Associate Director, Drug Product Validation (Injectables)

Meet Life Sciences Ltd.; Watertown (MA); On-site; USD 195,000 - 200,000; Full time

Job summary

Meet Life Sciences Ltd. is seeking an Associate Director of Drug Product Technical Services to lead validation activities for injectable assets in late-stage trials.

This on-site role is based in Watertown, MA and requires collaboration with regulatory, manufacturing, quality and development teams to ensure robust validation and a smooth transition from clinical to commercial manufacturing. The ideal candidate will drive formulation development for liquid and lyophilized products, oversee

Qualifications

• 10+ years in aseptic drug product formulation, validation and GMP manufacturing.
• Experience with liquid and lyophilized formulations, preferably oligonucleotides or biologics.
• Proven track record leading process validation campaigns for Phase III products.
• Experience with pre-filled syringes, autoinjectors, or combination products is highly desirable.
• Ability to develop and author regulatory submissions and to manage multiple projects.

Responsibilities

• Drive formulation development and validation of liquid and lyophilized drug presentations to meet phase-specific requirements.
• Lead process validation campaigns to prepare for regulatory approval and commercial manufacturing.
• Manage technology transfer activities with CMOs, ensuring GMP compliance and supply continuity.
• Author critical regulatory documentation, including sections of submissions related to drug product manufacturing.
• Oversee external manufacturing partnerships, ensuring timelines and quality standards are met.
• Collaborate with multidisciplinary teams to foster continuous process improvements.
• Review batch records, process instructions, and quality documentation to ensure adherence to standards.

Skills

Aseptic drug product formulation

Drug product validation

GMP manufacturing experience

Regulatory submissions

Project management

Cross-functional collaboration

Communication skills

Tools

CMO management

Job description

Meet Life Sciences Ltd. is seeking an Associate Director of Drug Product Technical Services to lead validation activities for injectable assets in late-stage trials.

This on-site role is based in Watertown, MA and requires collaboration with regulatory, manufacturing, quality and development teams to ensure robust validation and a smooth transition from clinical to commercial manufacturing. The ideal candidate will drive formulation development for liquid and lyophilized products, oversee