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Associate Director, Talent Solutions at Tandem Project Management Ltd.
Process Engineering SME– Biologics (Antibody Drug Conjugate) -UK or Ireland (Hybrid Work Arrangement)
We are seeking a highly experienced and driven Process Engineering Lead to support the design and delivery of a complex biologics manufacturing facility. This role focuses on upstream monoclonal antibody (mAb) production—including conventional batch and intensified fed-batch synthesis—as well as drug-linker conjugation processes using both Single-Use (SU) and Stainless Steel (SS) systems.
You will work across technical and project interfaces to ensure that engineering solutions are aligned with business goals, regulatory requirements, and sustainability targets. This position can be based in the UK or Ireland, with hybrid flexibility, and will play a key role in ensuring project design excellence and execution success.
Key Responsibilities:
* Provide technical leadership in the development and design of upstream fed-batch mAb production processes using SU and SS equipment.
* Lead or support process design for conjugation of monoclonal antibodies with cytotoxic drug-linkers, incorporating appropriate containment and safety requirements.
* Ensure scalability, sustainability, and GMP compliance in all technical solutions from lab to commercial scale.
* Serve as the SME Approver for equipment URSs and design documentation related to biologics and ADC manufacturing.
* Define scope boundaries and interfaces with adjacent work areas in collaboration with the Project Technical Manager (PTM).
* Ensure design and technical requirements are clearly documented and agreed with internal AZ stakeholders and external Designers.
* Collaborate with the Designer to ensure alignment with company standards, sustainability goals, and SME feedback throughout all design stages.
* Attend and contribute to project design reviews, technical tier meetings, risk reviews, and hazard studies (HOPs, LOPAs).
* Provide input to cost/schedule reviews and contribute to the project risk register.
* Support preparation for Engineering Council and Project Definition Rating Index (PDRI) assessments.
* Participate in procurement strategies, including contractor selection and defining technical scopes for work packages.
* Lead or support Design Assurance Reviews (30/60/90%) and equipment supplier engagements (FATs, SATs, DQs).
* Ensure C&Q strategy alignment in coordination with the C&Q Execution Lead, including planning for materials and resource needs.
* Monitor compliance through the Engineering Compliance Tracker and ensure all SHE standards are met.
* Qualifications & Experience:
* Degree in Chemical/Bioprocess Engineering, Biotechnology, or a related discipline. Advanced degrees preferred.
* Proven experience in biologics manufacturing, including upstream processing and conjugation technologies.
* Deep understanding of GMP requirements, process containment strategies, and large molecule manufacturing operations.
* Strong background in engineering design development, project execution, and technical governance in a regulated environment.
* Effective communication and stakeholder management skills, with ability to work across global teams and third-party partners.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Design and Engineering
* Industries
Pharmaceutical Manufacturing
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