Formulation Filling Lyophilization Supervisor (Off shift)
Site Name: USA - Pennsylvania - Marietta Posted Date: Jun 21 2021 Are you looking to enhance your technical capability by working in a global manufacturing environment that allows you to leverage best in class systems and technologies? If so, this role could be an ideal opportunity to explore. As a Formulation Filling Lyophilization Supervisor, you will be responsible for supervising under guidance from manager and higher level supervisory staff the aseptic buffer and vaccine formulation, vial filling lyophilizing, vial capping and vial inspection lines in secondary manufacturing operations to meet required quality, compliance and delivery targets of process validation lots and commercial products. You will also ensure manufacturing operations are executed in cGMP compliant manner and complies with company conformance standards and all applicable regulations. You will manage the training and qualifications for staff to insure all operating procedures are followed and compliant with all company defined standards and federal regulations. You will develop skills, supervise, lead and motivate a production team. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Supervise manufacturing processes, automation equipment and personnel to ensure quality operations. Proactively and continuously manage product risk and escalate risks through site management, consult with manager as needed. Supervise the day to day activities of operations associates and Electro Mechanical Technicians performing aseptic buffer and vaccine formulation, filling, lyophilization, capping and inspection manufacturing operations. Coordinate resources required to complete routine work and assigned special projects in a timely manner. Manage manufacturing operations through SAP functions. During active Technical Transfer projects, work with Local Team, Donor Site and Global Technology Support and assist Process PQMP and PQ/PV Execution. Assists with the development and implementation of productivity improvement plans using Industrial Excellence methodologies. Monitor and report progress of safety objectives, performance against schedule and number of defects. Identify the cause of the problems and continue to educate staff on solutions, accident avoidance and error reductions. Work towards becoming an SME in the development and maintenance of simple, effective, visual LSOPs for Equipment and Areas. Co-owner for Quality System Events related to aseptic formulation, filling, lyophilization, capping and inspection manufacturing operations. Support the process for and troubleshoots process deviations and equipment failures. Co-Responsible for RIMP activities in support of inspection readiness for the FFL Value Stream. Manage safe and efficient operations of assigned production areas of GSK Bio Marietta by ensuring all supervised personnel are adequately trained and perform routine inspections. Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS or BA in a biological, chemical science, or engineering or equivalent technical discipline with prior pharmaceutical production experience of 3 years, in vaccines or biopharmaceuticals and a minimum of 3 years in a role leading cross functional teams Preferred Qualifications: If you have the following characteristics, it would be a plus: Preferred experience should include supervising and managing production including aseptic technique, filling, and lyophilization, product visual inspection, input to scheduling and planning and regulatory compliance. Experience with delegating, training, evaluating, coaching and disciplining others is required. In lieu of this experience, completing the GSK graduate rotational program will be considered. The position requires the experience with travel internationally 10% of the time. Prior user experience with MS Project or similar project planning software. Experience with cGMPs, and the ability to quickly grasp and apply site policies and procedures and relate them to project scope. Must possess a technical understanding of industry and scientific principles and practices related to the business. Experience with leading cross-function / international teams. Full understanding of GMP's, and other applicable regulatory agency requirements with demonstrated success in application. Experience with a facility start-up in order to create, lead and design applicable systems preferred. Excellent organizational skills and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy. Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines. Demonstrated interpersonal and leadership skills. Experience with establishing, maintaining and supervising working relationships cross functionally. Experience with analyzing data and implement change. Experience with leading the process to generate the exchange of ideas to resolve problems, influence others, prioritize solutions, select optimal solutions and implement decisions. Sense of urgency, flexibility and accountability. Experience with communicating effectively, both verbally and in writing, to all levels within the organization as well as the skills to communicate site operations to outside agencies. Computer skills in Microsoft Office applications and the ability to quickly and easily learn new applications. Familiarity with Good Manufacturing Practices and NIH guidelines. Experience with following written procedures and document results in a neat and precise manner. Maintain a high level of integrity while balancing multiple priorities and responsibilities. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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