Senior Lead, Pediatric Drug Product Development

Relay Therapeutics; Cambridge (MA); On-site; USD 143,000 - 203,000; Full time

Job summary

Relay Therapeutics is seeking a senior Drug Product Lead to drive formulation development and manufacturing process optimization across our pipeline, with a focus on patient-centric approaches including pediatric formulations. You will oversee outsourcing to global CROs/CMOs and ensure alignment with program goals.

You will draft and review GMP documents, support regulatory submissions (IND/NDA) and guide technology transfer to manufacturing sites, collaborating across cross-functional teams in

Qualifications

• Advanced degree (doctoral or post-doctoral) in Pharmaceutics or Pharmaceutical Sciences.
• 8–10 years of relevant industry experience with oral solids and liquid suspensions.
• Experience in manufacturing process development and scale-up.
• Basics of pediatric product development and packaging configuration.
• Knowledge of cGMP and regulatory guidelines (US/EU/ICH).
• Ability to author and review technical reports for IND/NDA submissions.

Responsibilities

• Lead and manage outsourcing to CROs/CMOs to meet program goals.
• Draft, review and approve specs, batch records and GMP documents.
• Drive drug product process development and tech transfer to manufacturing sites.
• Collaborate with internal QA, AD/QC and third parties on stability studies.
• Evaluate new drug product technologies for life-cycle management.

Skills

Oral solids formulation

Liquid suspension formulations

Manufacturing process development

Scale-up

DoE

Statistical analysis

Education

Advanced degree (doctoral or post-doctoral) in Pharmaceutics / Pharmaceutical Sciences

Job description

Relay Therapeutics is seeking a senior Drug Product Lead to drive formulation development and manufacturing process optimization across our pipeline, with a focus on patient-centric approaches including pediatric formulations. You will oversee outsourcing to global CROs/CMOs and ensure alignment with program goals.

You will draft and review GMP documents, support regulatory submissions (IND/NDA) and guide technology transfer to manufacturing sites, collaborating across cross-functional teams in