Assoc Dir, Technical Operations

Job DescriptionWe are currently seeking an Associate Director to join Technical Operations as process expert to support new product introductions, technology transfers, continually monitor, troubleshoot and improve drug product operations conducted across the network on behalf of Alkermes. This role ensures robust, compliant, and efficient processes for drug product formulation (oral, vial, syringe filling etc). The position requires cross-functional collaboration with functions such as Quality, Regulatory, Supply Chain, R&D and external partners (CMOs).Responsibilities Build and maintain influential relationships with appropriate stakeholders both internally and externally while providing technical leadership and process engineering expertise to external supply teams to support the management of CMO’s in the Alkermes supply network. Lead technical input and guidance on drug product CMO vendor selections activities and product technical transfers in collaboration with Pharmaceutical Development and provide input to ensure network capabilities and competencies are available to conduct technical transfers to CMO’s should the network require alternative supply sources. Lead implementation of new technology or upgrade projects specific to Alkermes, at external CMO sites in conjunction with internal stakeholders and external CMO’s. Provide technical input and operational support during the design and execution of IQ/OQ/ PQ and PPQ qualification studies led by the CMO Validation / Alkermes Validation (Dev & External Quality). Contribute to technical input for product development where activity shall be performed by CMO to support new product introduction. Provide technical oversight at CMO’s for Drug Product Engineering trials for new product introductions, changes to existing processes 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 that critical and key parameters are appropriately identified for all Alkermes processes. Provide technical input and leadership support to drug product processes (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. This shall include for new products and processes the identification of critical process parameters (CPP’s) and how they are linked to critical quality attributes (CTQ’s) with determination of suitable ranges that ensure robust, compliant reliable product is consistently produced within the validated process. Provide technical leadership into drug product 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 providing subject matter expertise for drug product processes. Collaborate with PharmDev to develop new drug products that are robust, compliant, effective and efficient for commercial operations across the network. This shall include design of experiments (DoE) to determine suitable ranges for critical process parameters and verification that such ranges produce product that meets critical to quality attributes (CTQ’s). 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. Support new product launches by providing the necessary technical expertise to ensure that the commercial manufacturing process is robust and scalable. Qualifications Engineering or Science Qualification (Bachelors/ Master’s Degree preferred) with significant drug product engineering experience in high volume pharmaceutical environment, providing engineering support for new product/process introductions in accordance with EHS and cGMP standards in pharmaceutical or healthcare packaging industry. Experience working in a cGMP environment with strong discipline with regard to change control and risk assessment to evaluate existing manufacturing processes and workflows to identify areas that could benefit from changes and improvements. Proven problem-solving abilities – able to identify facts, consider alternative approaches and evaluate the most appropriate action and timely close out of investigations and associated CAPA’s. In-depth knowledge of pharmaceutical drug products (Tablets/Capsules/Granules/Liquids/Vials/Syringe) with knowledge of global regulatory requirements related to design and control of these processes. Drug product operations experience in areas such as oral dosage, vial and syringe filling. Strong engineering and science capability with hands on experience with equipment and processes with experience in a technical role within a high-volume manufacturing environment. An ability to quickly understand new technologies, comprehend operating principles and work with technical teams to troubleshoot processes. Team player with an ability to lead collaborations and work seamlessly with cross functional colleagues to drive change and effective execution. Excellent verbal, written communications including technical report and investigation writing aligned with excellent presentations skills and influencing skills. There is ~20% of domestic / international travel associated with this role.