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).
Responsibilities
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
Qualifications
. Engineering or Science Qualification (Bachelors/ Master’s Degree preferred) with significant drug product and packaging engineering experience in high volume pharmaceutical and/or healthcare packaging, 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 primary and secondary packaging of pharmaceutical drug products (Tablets/Capsules/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 solid dosage, vial and syringe filling.
Strong mechanical capability with hands on experience with equipment, preferably experience in a technical role within a high-volume manufacturing environment.
Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerances and associated relationship with materials, product and process design deployed within the packaging design.
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.
About Us
Why join Team Alkermes?
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has 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 various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
