Associate Director, Technical Operations

We are currently seeking an Associate Director as technical process expert to support new product introductions, technology transfers, continually monitor, troubleshoot and improve drug product and packaging operations conducted across the network on behalf of Alkermes. This role ensures robust, compliant, and efficient processes for drug product formulation (solid oral, vial and syringe filling etc), technology transfer, and packaging operations. The position requires cross-functional collaboration with functions such as Quality, Regulatory, Supply Chain, R&D and external partners (CMOs).

Build and maintain influential relationships with appropriate stakeholders both internally and externally while providing technical leadership and packaging engineering expertise to external supply teams to support the management of CMO’s in the Alkermes supply network.

Provide technical input and guidance on drug product and packaging CMO vendor selections activities and drug product/packaging technical transfers in collaboration with Pharmaceutical Development and provide input to ensure network capabilities and competencies are available to tech transfer to CMO’s should the network require alternative supply sources.

Lead implementation of new technology or upgrade projects specific to Alkermes, at external CMO packaging sites in conjunction with internal stakeholders and external CMO’s.

Provide technical input and operational support during the design and execution of packaging IQ/OQ/ PQ and PPQ qualification studies led by the CMO Validation / Alkermes Validation (Dev & External Quality).

Contribute to technical input for primary and secondary packaging development where activity shall be performed by CMO and shipping development studies as required to support new product introduction.

Provide technical oversight at CMO’s for Packaging Engineering trials, whether these are driven by new product introduction, change of secondary packaging components/ process, or internal change (change to primary containers or process) ensuring that appropriate controls are in place and detailed in Standard Operating procedures or Batch records, ensuring that these are continually updated to streamline and optimize the process.

Ensure Design Control is maintained for secondary packaging of commercial combination device products via initiation of design control document maintenance, design related change controls and execution of verification activities that are associated with CMO’s.

Ensure that critical and key parameters are appropriately identified for all Alkermes Packaging processes and that the Packaging Control Strategy is maintained as a lifecycle document.

Provide technical input and leadership support to drug product processes (solid oral, vial and syringe filling etc), exhibiting an ability to quickly comprehend technical processes, troubleshoot and continually improve processes with key stakeholders.

Contribute to regulatory filings and CMC as required.

Provide technical leadership into drug product and packaging investigations in conjunction with CMO and cross functional support teams to ensure root cause is identified and sustainable CAPAs are in place. 

Responsible for the day-to-day process operations conducted on behalf of Alkermes at CMO’s.  Process owner for the manufacturing processes and ensure the manufacturing process operates effectively and efficiently, to ensure excellence in the supply of product to our patient’s.

Work with network suppliers (internal and external) to maintain and publish KPIs that are focused on delivering the most efficient processes.

Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs, work in conjunction with other departments to ensure production, quality and safety targets are met and drive systems and processes to eliminate customer complaints.

Identify and mitigate risk through active participation in our risk management process.

Maintain and develop packaging competency library to be used as a reference point for existing and future product strategies.

Collaborate with PharmDev to develop new drug product and packaging designs that are suitable for commercial operations across the network.

Provide  technical expertise and guidance in drug product manufacturing operations in areas such as process development, troubleshooting to determine root cause and input to potential future site and process selection for new products

 

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