The Senior Director MSAT will serve as a senior leader within the Tech Ops organisation, playing a central role in shaping future technical capability and driving sustained excellence across a complex and expanding neuroscience portfolio.
Reporting to the VP, Technical Operations, the Snr. Director will be accountable for the technical oversight and lifecycle management of commercial manufacturing processes across a global network. The Snr. Director will play a key role in ensuring robust, compliant, and reliable manufacture of commercial products. This leader will also serve as the scientific and industrialization engine for Technical Operations partnering closely with Pharmaceutical Development during late-stage development through to commercialisation.
We are seeking a highly motivated individual with expertise in process science, development and commercial manufacturing, to provide strong organisational, strategic, and scientific leadership to a newly forming MSAT organisation.
Hyrid role:
- Technical Ownership & Process Stewardship
Provide technical stewardship of manufacturing processes ensuring organizational ownership and retention of product knowledge, process knowledge, technical risk, and lifecycle strategy. - Process Robustness and Performance
Define and implement standardized approaches for technical investigations, statistical analysis/trending, process control and product performance monitoring. Ensure API and Drug Product processes are robust, reliable, and capable of consistently delivering high-quality products. - Process Monitoring
Establish and maintain systems and processes for identifying and controlling Critical Process Parameters (CPPs) and executing Continuous Process Verification (CPV) to ensure ongoing compliance and performance. - Lifecycle Support and Improvement
Provide guidance to the design and optimization of commercial manufacturing processes including process robustness, yield optimisation and process scale up. Support Operations Lifecycle Management (OLM) programs by contributing technical leadership to key projects and continuous improvement initiatives. - Technical Transfer
Develop/enhance systems, tools, and cross-functional processes that support the efficient transfer of new products into manufacturing facilities and CMOs. Provide technical leadership to proactively identify and resolve challenges during scale-up, validation, and launch phases. - Business Partnerships
Establish strong relationships with Quality, Manufacturing Operations, Regulatory CMC, Supply Chain, Finance and Pharmaceutical Development to ensure timely delivery of late stage and commercial portfolios goals. Influence stakeholders and communicate with senior leadership on issues, risks, and opportunities - Digital and Data
Champion the integration of digital tools, automation, and advanced analytics to enhance process visibility, enable predictive insights, and accelerate decision-making across the technical operations landscape. - Innovative Technologies and Equipment
Assess and implement new technologies and equipment that enhance manufacturing performance, reliability, and scalability. Develop and Empower the MSAT Team
Lead, mentor, and grow a high-performing team. Foster a culture of accountability, innovation, and continuous improvement through strong leadership and capability development.#LI-Hybrid
Qualifications
- Advanced Degree Preferred – Masters or PhD in Chemical Engineering, Pharmaceutical Sciences, or a related technical field.
- Minimum of 15 years’ relevant experience - Proven leadership in pharmaceutical manufacturing, technical operations, or process development, including oversight of internal and external (CMO) networks.
- MSAT expertise - Deep understanding of product quality attributes control strategies as applied to pharmaceutical processes. Sound background in processing and engineering fundamentals, particularly in the OSD space.
CMC and Tech Transfer Expertise – Demonstrated success in technology transfer, scale-up, validation, and commercialisation of pharmaceutical products.
External Network Management – Experience managing technical operations across CMOs and external partners.
Financial and Business Acumen – Skilled in cost analysis, budgeting, forecasting, and preparing business cases to support strategic decision-making.
Operational Excellence Mindset – Solid background in Lean, Six Sigma, or similar methodologies with a track record of driving continuous improvement.
Regulatory and Audit Readiness – Deep understanding of cGMP, ICH, and global regulatory expectations; experience supporting inspections and managing responses.
People Leadership – Proven ability to lead, develop, and inspire high-performing technical teams in a matrixed or global environment.
Skills Required
- Minimum of 15 years relevant experience in pharmaceutical manufacturing, technical operations, or process development, including oversight of internal and external (CMO) networks
- MSAT expertise with deep understanding of product quality attribute control strategies and processing fundamentals, particularly in OSD
- CMC and technology transfer experience including scale-up, validation, and commercialization of pharmaceutical products
- Experience managing technical operations across CMOs and external partners
- Financial and business acumen including cost analysis, budgeting, forecasting, and business case development
- Operational excellence background (Lean, Six Sigma, or similar) with a track record of continuous improvement
- Regulatory and audit readiness with deep understanding of cGMP, ICH, and global regulatory expectations and inspection support experience
- Proven people leadership experience leading and developing high-performing technical teams in a matrixed/global environment
- Advanced degree (Master's or PhD) in Chemical Engineering, Pharmaceutical Sciences, or related technical field
What We Do
Alkermes focuses on the development of innovative medicines that seek to address unmet needs of people living with serious mental illness, addiction, and cancer. As a fully-integrated, global biopharmaceutical company, we apply our scientific expertise and proprietary technologies to develop products that are designed to make a meaningful difference in the way patients manage their disease. We are inspired by some of the most pressing public health challenges of our time to help advance innovation with the potential to improve treatment options and outcomes for patients. Beyond our important mission of developing medicines, we believe it is our responsibility to take a holistic approach as we seek to support patients, caregivers, and broader impacted communities. In this context we also work to help support and enhance the systems through which these complex diseases are treated. We are committed to patient engagement, disease education and awareness, and advocacy for important policies that support equitable access to quality treatment. Headquartered in Dublin, Ireland, we have an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. See our Community Guidelines: https://www.alkermes.com/social-community-guidelines
