Director, CMC Bioprocess - Late-Stage

ClinLab Solutions Group; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

ClinLab Solutions Group in Boston, MA seeks Associate Director/Director, CMC (Late Stage Development, Bioprocess) to lead monoclonal antibody process development and manufacturing strategies across CMC functions.

The role requires deep bioprocessing expertise, experience with external manufacturing, and ability to drive PPQ readiness, CPV, and regulatory interactions with FDA/EMA. Strong leadership and cross-functional collaboration are essential.

Qualifications

• 10+ years of biologics process development or MSAT experience.
• Experience across upstream or downstream bioprocess development and MSAT.

Responsibilities

• Lead CMC strategy and execution for monoclonal antibody programs, integrating cross-functional inputs.
• Provide technical leadership for upstream and/or downstream development, scale-up, tech transfer, and GMP manufacturing.
• Drive late-stage development, process characterization, and validation strategies through PPQ and CPV.
• Act as primary interface with external manufacturing organizations, overseeing plans and campaigns.
• Review data to identify trends, risks, and CAPAs; lead investigations and change controls.
• Translate process understanding into robust control strategies (CQAs, CPPs).
• Collaborate with regulatory teams to support submissions and responses.

Skills

Monoclonal antibodies

CMC strategy

Process development

External manufacturing

PPQ/CPV

Regulatory liaison

QbD/DoE

Technical leadership

Education

Bachelor’s in chemical/biochemical engineering or related

MS/PhD in related discipline

Job description

ClinLab Solutions Group in Boston, MA seeks Associate Director/Director, CMC (Late Stage Development, Bioprocess) to lead monoclonal antibody process development and manufacturing strategies across CMC functions.

The role requires deep bioprocessing expertise, experience with external manufacturing, and ability to drive PPQ readiness, CPV, and regulatory interactions with FDA/EMA. Strong leadership and cross-functional collaboration are essential.