Associate Director Manufacturing
Ireland or United Kingdom
The Associate Director of Manufacturing will lead the oversight and management of drug substance, drug product and packaging manufacturing operations. This role requires a strategic leader with a strong background in biopharma/pharma manufacturing, regulatory compliance, and quality focus.
Roles and Responsibilities
- Lead and manage drug substance, drug product and packaging manufacturing activities across a network of external contract manufactures, ensuring adherence to production schedules, quality standards, and regulatory requirements.
- Leads the Amicus external supply operating team with a core objective of maintaining continuity of compliant supply.
- Lead by influencing and setting objectives for each of their CMOs and ensure all team members are fully engaged to deliver the maximum benefits for the team, the CMO’s and External Supply in the spirit of partnership.
- Develops and executes the implementation of strategic and tactical plans to secure timely supply of product and achieve cost targets as well as all other performance targets.
- Responsible for managing financial resources and delivering the financial plan of their CMO network.
- Lead the development and execution of manufacturing and supply plans to ensure the continuous short-term and long-term supply of products from CMOs.
- Manage Deviations, Change Controls and CAPAs in collaboration with CMO to close in a timely manner. Collaborate closely with Amicus quality to ensure batch release plans are executed successfully.
- Ensure strict adherence to regulatory guidelines (e.g., FDA, EMA, MHRA) and Good Manufacturing Practices (GMP) throughout the product manufacturing lifecycle.
- Collaborate with the CMO senior leadership teams to ensure any areas of conflict get resolved in a timely manner and escalate to senior management as appropriate if required Identify and mitigate risks associated with manufacturing operations, proactively implementing strategies to prevent deviations and ensure continuous improvement.
- Drive initiatives for process optimization, technology implementation and best practices to improve manufacturing operations.
- Foster strong relationships with internal and external stakeholders, ensuring alignment of manufacturing strategies with CMO and organizational goals.
- Bachelor's or Master’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related field.
Professional Work Experience Requirements
- 10+ years experience in pharmaceutical and/or biopharmaceutical manufacturing of drug substance, with a strong understanding of GMP and regulatory compliance.
- Preferably small molecule manufacturing experience.
- Excellent communication, negotiation, and CMO management abilities.
- Strong problem-solving skills and a proactive approach to driving continuous improvement in manufacturing processes.
Experience and Skills
- External manufacturing oversight and experience working with CMOs.
- Project Management skills and coordination of CMO activities.
- Navigating change control review and approval process.
- CAPA implementation and CAPA effectiveness review.
- Experience with continuous manufacturing; upstream and downstream.
- SME for upstream cell culture and downstream purification.
- Knowledge of batch record development and management for drug substance manufacturing.
- Problem-solving and troubleshooting skills.
- Ability to work independently or as part of a team.
- Strong verbal, written communication skills and strong interpersonal skills.
- Knowledge of lean manufacturing principles.
- Experience working in collaboration with CMO’s.
- Hands on cell culture experience with cGMP commercial manufacturing.
- Familiarity with perfusion bioreactor systems coupled with ATF and other harvesting technologies, Unicorn chromatography control system and Delta V.
- Knowledge of cGMP manufacturing of recombinant enzymes.
- Demonstrated alignment with Amicus Mission Focus Behaviors.
- Passion for rare disease and patient focused.
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