Alkermes

Sr Dir, Manufacturing, Science and Technology

Alkermes  •  Athlone, IE (Hybrid)  •  1 hour ago
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Job Description

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

  • 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.

Alkermes

About Alkermes

At Alkermes, we apply our deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Our patient-inspired science, integrated research strategy, sophisticated development capabilities and specialized commercial infrastructure enable us to pursue the development and commercialization of innovative new medicines, including those for people with conditions that have traditionally been overlooked or stigmatized.

Our greatest strengths at Alkermes are our people and our inherent empathy for patients, families and caregivers. Neurological and psychiatric disorders strike people at the core of who they are and impact many facets of their lives. We work with urgency to develop new treatment options for people living with these conditions.

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. We remain committed to patient engagement, responsible and sustainable operations, and equitable access to quality treatment.

Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio.

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Industry
Biotech & Life Sciences
Company Size
1,001-5,000 employees
Headquarters
Dublin, IE
Year Founded
1987
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