Strategic Director, Biologics CMC Development

Dechra Pharmaceuticals PLC; Boston (MA); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Job summary

Dechra Pharmaceuticals PLC in Boston is seeking a Director, Biologics CMC Development to provide strategic and technical leadership for DS processes across monoclonal antibody programs. You will drive cell line development, upstream and downstream processes, and analytical method development in collaboration with CDMOs and CROs.

As a member of the CMC Leadership Team you will align development with regulatory expectations, support IND-enabling and clinical programs, build scalable manufacturing

Qualifications

• Minimum 9+ years of biotechnology or pharmaceutical industry experience with biologics drug substance development.
• Ph.D. in Pharmaceutical Sciences or related field required.
• Experience managing CDMOs/CROs and technology transfer.
• Strong knowledge of Quality by Design (QbD) and lifecycle management.
• Ability to travel domestically and internationally (approx. 25–30%).

Responsibilities

• Develop and execute biologics CMC development strategies aligned with portfolio objectives.
• Lead cell line selection, upstream and downstream process development, and analytical method development.
• Oversee CDMO/CRO partnerships, governance, and performance metrics.
• Ensure regulatory readiness, quality compliance, and collaboration with regulatory affairs.
• Mentor scientists and build organizational capabilities for late-stage development.

Skills

Biologics development

Process development

Regulatory knowledge

GMP experience

Education

Ph.D. in Pharmaceutical Sciences

Job description

Dechra Pharmaceuticals PLC in Boston is seeking a Director, Biologics CMC Development to provide strategic and technical leadership for DS processes across monoclonal antibody programs. You will drive cell line development, upstream and downstream processes, and analytical method development in collaboration with CDMOs and CROs.

As a member of the CMC Leadership Team you will align development with regulatory expectations, support IND-enabling and clinical programs, build scalable manufacturing