Manager (Days), Sterile Drug Product, QA Manufacturing Operations
3 weeks ago
Bristol Myers Squibb Ireland Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the companys first European biologics manufacturing facility. This state-of-the-art facility will produce multiple therapies for the companys growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been awarded Biopharma Company of the Year 2019 in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020, 2021 and 2022. Position Summary BMS Cruiserath Biologics is seeking to recruit a Manager, for QA Manufacturing Operations for Sterile Drug Products. Reporting to the Senior Manager, of QA Manufacturing Operations for Sterile Drug Products, the Manager will support the start-up of a commercial drug product manufacturing facility for its biologics commercial portfolio and clinical pipeline. This shall be achieved by working in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification. Providing quality assurance oversight for all phases of the project. In addition, this role will support readying the facility for manufacturing operations, supporting the Tech Transfer program for new products introduced into the facility. Post start-up the successful candidate will support the execution and maintenance of the QA activities related to the commercial sterile drug product manufacture and release activities in Cruiserath. The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite. The role will be both challenging & rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS. The Sterile Drug Product project scope includes construction and commissioning of new SDP product suite with parts prep, formulation, aseptic filling and capping of liquid & freeze-dried vials, aseptic filling of syringes, and Visual Inspection capabilities. The project also includes new and expanded clean utilities. Key Responsibilities During Start Up Responsible coaching and development of staff and direct personnel to achieve operational goals and ensure the timely completion of tasks. Provide QA oversight for Aseptic Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping, and Visual Inspection Work with the project design, CQV, & the Automation/CSV teams to facilitate the implementation of the project design and validation of the project for Drug Product Operations. Prepare/Review/Approve documentation (SOPs, MBRs, Logbooks) required to enable manufacturing start-up and complete training on time. Support CQV / Tech Transfer / Operational Readiness activities including but not limited to: New Product Introduction SOP Development and Implementation Training Material development MES / MBR Design CQV support as required Participation in GMP reviews for new facility construction and new equipment support systems Develop and execute training programs in support of multiproduct manufacturing. Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc. Key Responsibilities During Commercial Operations Primary delegate for Snr Manager, QA Manufacturing Operations for Sterile Drug Product providing QA support to manufacturing team for commercial and clinical sterile drug product Responsible for coaching and development of staff and direct personnel to achieve operational goals and ensure the timely completion of tasks. Provide Quality oversight for Batch record review activities to support the Disposition process for commercial and clinical drug product Provide QA oversight for Aseptic Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping, and Visual Inspection QA Operations review of events and investigations Authoring, review, and approval of QA-related procedures QA support for implementation of Manufacturing Execution System (MES) and development of batch records Change control assessment and CAPA evaluation/CAPA close-out. Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements. Participation in internal, corporate, and regulatory inspections Drives and supports culture of continuous improvement initiatives and safe working practices. Designee for Snr Manager, Sterile Drug Product, QA Manufacturing Operations, when required. Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc. Qualifications & Experience The successful candidate must possess: BSc in Science or related discipline with a minimum of 5 years experience within the Biopharmaceutical/Pharmaceutical industry Detailed knowledge of Sterile Drug Product would be a distinct advantage. Understanding and experience of the principles of Annex 1 and how they translate into a contamination control strategy for sterile manufacture. The candidate will have proven success working well in a team environment, and the ability to manage people A clear understanding of cGMP requirements for manufacturing and/or systems and compliance Required to work on his/her own initiative in addition to working as part of a team and must be open to shift work. Must be able to work across a team matrix to meet accelerated timelines. Excellent communication and presentation skills are essential. Excellent time management and organizational skills along with a proven ability to multi-task Employees are expected to display the BMS Biopharma Behaviors, which enable them to be successful and perform at their highest level. Why you should apply You will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. Youll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym Skills: sterile drug product knowledge Annex 1 contamination control strategy
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