Director, Drug Substance Commercial Manufacturing - Remote

Kailera Therapeutics, Inc.; Waltham (MA); On-site; USD 196,000 - 240,000; Full time

Benefits offered by this job

Monthly wellness stipend

Generous 401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Equity grants

Job summary

Kailera Therapeutics, Inc. seeks a Director of Drug Substance Commercial Manufacturing in Waltham, MA. This onsite role leads DS technology transfer, MSAT, and manufacturing oversight across the Kailera CDMO network, ensuring lifecycle management from transfer through launch and CPV.

You will coordinate with Quality, Regulatory CMC, Drug Product, Supply Chain, and PMO to ensure processes remain aligned with approved specifications and regulatory commitments. International travel may be required.

Qualifications

• 10+ years in drug substance technical operations
• 5+ years leadership with external manufacturers
• Experience with DS manufacturing campaigns at CDMOs
• Deep expertise in synthetic peptide DS manufacturing
• Experience in technology transfer, PPQ, CPV
• Strong understanding of cGMP and regulatory DS expectations
• Excellent communication and travel ability
• Experience with DS CMC documentation for regulatory submissions

Responsibilities

• Lead DS transfer to CDMOs and ensure adherence to approved processes
• Oversee DS technology transfer, validation, commercialization, and lifecycle management
• Provide technical ownership of commercial peptide DS processes
• Drive CPV, CAPAs, change control, and investigations across the network
• Provide technical leadership for CDMO development, manufacturing, and governance
• Support DS CMC documentation, regulatory submissions, and inspection readiness
• Evaluate CDMO selection, audits, and external spend management
• Build and develop MSAT and tech transfer teams while partnering cross-functionally

Skills

DS technology transfer

MSAT leadership

external manufacturing oversight

process validation

CPV / continued process verification

regulatory alignment

communication / stakeholder mgmt

budget & accountability

Education

Bachelor’s degree in chemistry / chemical engineering / pharmaceutical sciences

Advanced degree (M.S., Ph.D.)

Job description

Kailera Therapeutics, Inc. seeks a Director of Drug Substance Commercial Manufacturing in Waltham, MA. This onsite role leads DS technology transfer, MSAT, and manufacturing oversight across the Kailera CDMO network, ensuring lifecycle management from transfer through launch and CPV.

You will coordinate with Quality, Regulatory CMC, Drug Product, Supply Chain, and PMO to ensure processes remain aligned with approved specifications and regulatory commitments. International travel may be required.