Step Into a Senior Technical Leadership Role at the Interface of API Manufacturing and Global Supply
Associate Director, External Operations - API
Imagine taking ownership of the technical performance and continuous improvement of active pharmaceutical ingredient (API) manufacturing across a global network of contract manufacturing partners, where your expertise directly influences product quality, supply reliability, and patient outcomes worldwide.
This role sits at the intersection of science, manufacturing, and external operations leadership, acting as the key technical authority between development, commercialization, and external manufacturing partners across both API and drug product supply chains.
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 operations 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 scientific/engineering discipline
- 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.
The next step for you:
If this opportunity aligns with your experience, please send your CV or reach out for a confidential discussion.
All applications are handled in strict confidence.
Next Generation Recruitment specialises in Supply Chain, Procurement, Engineering, Quality, Technical, and Operations roles (permanent, contract, and temporary).
Your data will never be shared outside our organisation without your prior written consent.
