Senior Biologics DP Operations Leader

Dechra Pharmaceuticals PLC; Boston (MA); On-site; USD 145,000 - 170,000; Full time

Job summary

Dechra Pharmaceuticals PLC is seeking a Senior Manager, Biologics Drug Product Operations in the US to lead external manufacturing programs for biologics products. You will manage CDMOs, support technology transfer, process development, PPQ and commercial readiness, while ensuring GMP compliance and regulatory alignment.

The role reports to the Biologics Drug Product Operations Director, with responsibility for late-stage development, validation campaigns and collaboration across CMC, Quality,

Qualifications

• Bachelor, Master or PhD in Life Sciences, Pharmaceutical Sciences, Bioprocess or Chemical Engineering, or related science.

Responsibilities

• Act as PiP during GMP manufacturing campaigns, provide onsite leadership and issue resolution.
• Oversee external CDMO manufacturing programs, including clinical, PPQ and commercial GMP runs.
• Lead technology transfer, process characterization, validation strategy and PPQ readiness.
• Review and approve manufacturing documentation, deviations, investigations and change controls.
• Ensure compliance with cGMP and regulatory expectations; support regulatory submissions and inspections.

Skills

Biologics development

CDMO management

PiP experience

GMP compliance

CMC regulatory submissions

Education

Bachelor/Master/PhD in Life Sciences or related

Job description

Dechra Pharmaceuticals PLC is seeking a Senior Manager, Biologics Drug Product Operations in the US to lead external manufacturing programs for biologics products. You will manage CDMOs, support technology transfer, process development, PPQ and commercial readiness, while ensuring GMP compliance and regulatory alignment.

The role reports to the Biologics Drug Product Operations Director, with responsibility for late-stage development, validation campaigns and collaboration across CMC, Quality,