Role: Upstream Manufacturing Director

Location: UK (remote based)

Full time permanent employment

Planet Pharma are recruiting for anUpstream Manufacturing Directoron behalf of a global leader and innovator in antibody-drug conjugates (ADCs), specializing in their lifecycle from discovery to commercialization. The company has advanced technology and robust pipeline extend beyond hematology, targeting solid tumor cancers.

Key Responsibilities

• Collaborate with UK researchers and CMOs to transfer processes, including cell line development and cell culture procedures.
• Review and analyze upstream Master Batch Records for adherence to process descriptions and compile data into electronic databases.
• Coordinate batch record reviews with quality teams in a collaborative environment.
• Analyze process development and GMP campaign data to optimize cell culture performance and ensure process robustness.
• Monitor and support upstream production runs, process transfers, characterization, and validation at CMOs.
• Contribute to writing development reports, INDs, and BLAs, ensuring timely regulatory submissions in collaboration with regulatory teams.

You Will Have

• Master’s/PhD in Biochemistry, Chemistry, or related field with extensive biotechnology experience.
• Expertise in GMP upstream/downstream processes, process development, and technology transfer.
• Skilled in cell culture process development, optimization, and regulatory responses.
• Strong experience in GMP manufacturing and process transitions to CMOs.
• Proficient in process characterization, master batch record reviews, and process improvements.
• Effective communicator, able to articulate issues to leadership and collaborate with internal teams and CMOs.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com