Senior Leader, Drug Substance Development & Manufacturing

Relay Therapeutics; Cambridge (MA); On-site; USD 145,000 - 207,000; Full time

Job summary

Relay Therapeutics is seeking a senior leader to oversee late-stage small molecule drug substance development and manufacturing at global CRO/CMO sites. The role emphasizes regulatory compliance and scalable processes to support commercialization.

The candidate will apply extensive cGMP experience, QbD tools, and tech transfer expertise, coordinating with cross-functional teams to drive timely delivery and ensure high-quality outcomes in a fast-paced environment.

Qualifications

• 7+ years in late-stage drug substance development and manufacturing.
• Experience with global CMOs and tech transfer in a virtual pharma setting.
• Proficient in cGMP and scale-up of new chemistry.
• Familiar with QbD, DOE, PAT, and data analytics for CQA/CPP.
• Strong outsourcing experience and ability to manage external partners.
• Excellent communication and problem-solving skills.

Responsibilities

• Manage all late-stage small molecule drug substance development and manufacturing at global CRO/CMO sites.
• Ensure regulatory compliance at vendor sites.
• Lead late-stage development toward commercialization of candidates.
• Provide leadership with minimal supervision at CRO/CMO sites.
• Identify in-process controls for potential commercial validation; lead tech transfer for scale-up.
• Review and approve specifications, batch records, and critical documents.
• Collaborate with QC, supply chain and QA for aligned deliverables.
• Write and review regulatory documents (NDA and MAA).

Skills

Late-stage PD

Manufacturing experience

Tech transfer

cGMP knowledge

Process scale-up

Regulatory writing (NDA/MAA)

Analytical problem solving

Cross-functional communication

Education

Chemical engineering (Bachelor+)

Organic chemistry (PhD or equivalent)

Tools

NMR

IR

Mass spectrometry

ReactIR

UV/Vis

HPLC

GC

TLC

Chiral separations

Job description

Relay Therapeutics is seeking a senior leader to oversee late-stage small molecule drug substance development and manufacturing at global CRO/CMO sites. The role emphasizes regulatory compliance and scalable processes to support commercialization.

The candidate will apply extensive cGMP experience, QbD tools, and tech transfer expertise, coordinating with cross-functional teams to drive timely delivery and ensure high-quality outcomes in a fast-paced environment.