Associate Director, Technical Operations

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Associate Director, Technical Operations, Dublin col-narrow-left

Client : Alkermes

Location : Dublin, Ireland

Job Category : Other

EU work permit required : Yes

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Job Reference : 7e7236ac6ca0

Job Views : Posted : Expiry Date : 18.08.2025

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Job Description : We are currently seeking an Associate Director, technical process expert to support new product introductions, technology transfers, monitor, troubleshoot, and improve drug product and packaging operations across the network for Alkermes.

This role ensures robust, compliant, and efficient processes for drug formulation (solid oral, vial, syringe filling), technology transfer, and packaging.

The position requires collaboration with Quality, Regulatory, Supply Chain, R&D, and external partners (CMOs).

Build and maintain relationships with stakeholders, providing technical leadership and packaging engineering expertise to support CMO management.

Provide technical guidance on drug product and packaging vendor selection, technology transfer, and ensure network capabilities for transfers.

Lead implementation of new technology or upgrades at external CMO sites.

Support qualification studies (IQ / OQ / PQ, PPQ) during packaging validation.

Contribute to development activities for primary and secondary packaging and support shipping development for new products.

Oversee packaging engineering trials at CMO sites, ensuring controls are in place and processes are optimized.

Maintain design control for secondary packaging, including change controls and verification activities.

Identify critical parameters and maintain the Packaging Control Strategy as a lifecycle document.

Provide technical input and leadership in drug product processes, troubleshooting, and process improvements.

Contribute to regulatory filings and CMC documentation.

Lead investigations into drug product and packaging issues, ensuring root cause analysis and CAPAs.

Manage day-to-day manufacturing processes at CMO sites, ensuring efficiency and compliance.

Work with suppliers to publish KPIs focused on process efficiency.

Apply engineering techniques to reduce time to market while meeting regulatory, project, and cost targets.

Participate in risk management to identify and mitigate risks.

Develop and maintain a packaging competency library for current and future products.

Collaborate with PharmDev on new drug product and packaging designs for commercial use.

Provide expertise in drug manufacturing operations, process development, troubleshooting, and site selection.

Qualifications include a degree in Engineering or Science, with significant experience in drug product and packaging engineering in high-volume pharma or healthcare packaging, supporting new product / process introductions in compliance with EHS and cGMP standards.

Experience in a cGMP environment with change control and risk assessment discipline.

Deep knowledge of primary and secondary packaging processes and global regulatory requirements.

Experience in drug operations like oral solids, vials, and syringes.

Strong mechanical skills, hands-on equipment experience, and ability to interpret engineering drawings.

Ability to quickly learn new technologies, troubleshoot, and work collaboratively across teams.

Excellent communication, reporting, presentation, and influencing skills.

Approximately 20% travel domestically and internationally.

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