Posted: 18 June
The role
What you’ll achieve (and why it matters):
Bring deep technical expertise and leadership into a highly regulated, global manufacturing network where your decisions shape process robustness, compliance, and performance:
Act as the technical lead for API manufacturing activities across a network of external manufacturing organisations and downstream drug product processes
Ensure compliance with cGMP, regulatory expectations, and internal quality systems across all contract manufacturing operations
Apply strong chemical engineering and process science expertise to understand, control, and optimise API manufacturing processes
Analyse process trends across external sites, identifying opportunities to improve yield, reduce impurities, and enhance process efficiency
Oversee routine API production performance, investigations, change controls, CAPAs, and ongoing process monitoring
Define and maintain critical quality attributes (CQAs) and critical process parameters (CPPs) for new and existing processes
Provide technical input into control strategies, master batch records, specifications, and commercial documentation
Support technology transfers, validations, and new product introductions across the external manufacturing network
Lead or contribute to regulatory filing strategy by providing technical CMC input and ensuring manufacturing readiness prior to submission
Support and respond to regulatory inspections and external audits, ensuring robust technical justification and compliance
Partner closely with process development teams to ensure smooth transition from development to commercial manufacturing
Contribute to network optimisation activities including vendor selection, capability assessment, and technical due diligence
Provide technical leadership for cross‑functional projects across supply chain, quality, validation, and operations
Manage, coach, and develop direct reports to build technical capability and high performance within the team
Business partnership and leadership impact:
Build and maintain strong, trust‑based relationships with contract manufacturing partners
Act as a key technical advisor in strategic and operational decision‑making for external manufacturing
Support development of business cases for new products, transfers, and manufacturing strategies
Contribute to competency assessments and technical evaluations of external partners
Provide input into budgets, forecasts, and supply strategy planning from a technical perspective
Drive cross‑functional alignment across technical operations, quality, supply chain, and development functions
Promote collaboration and ensure effective integration of external manufacturing operations into broader business objectives
Your edge (desired, not required):
Bachelor’s degree in Chemical Engineering, Chemistry, Pharmacy, or related
8–12 years’ experience in pharmaceutical or regulated manufacturing environments
Strong background in API manufacturing, process development, or technical operations
At least 2 years in a senior or leadership‑level role within a manufacturing or technical operations environment
Strong understanding of both API and drug product (DP) manufacturing processes
Proven experience in process optimisation, investigations, and root cause problem solving
Experience with GMP environments, regulatory inspections, and CMC documentation
Strong project management and cross‑functional leadership capability
Excellent communication, stakeholder management, and influencing skills
Ability to work independently, lead technical decisions, and drive continuous improvement
Willingness to undertake approximately 20% domestic and international travel
Why this role matters
This is a senior technical leadership opportunity at the heart of global pharmaceutical manufacturing, where you will directly influence how critical medicines are produced, controlled, and delivered. Your work will ensure manufacturing processes remain robust, compliant, and continuously improving across a complex international supply network.
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