- York, PA
Site Name: USA - Pennsylvania - Harrisburg, USA - Pennsylvania - Marietta
Posted Date: Oct 12 2020
This individual will supervise Bulk Adjuvant Manufacturing Operator 1s and Electromechanical Technicians to meet required quality, compliance and delivery targets. Ensure manufacturing operations are executed in cGMP compliant manner and complies with company conformance standards and all applicable regulations. Manage the training and qualifications for staff to insure all operating procedures are followed and compliant with all company defined standards and federal regulations. 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 Production Operator 1s and Electro Mechanical Technicians performing Bulk Adjuvant Manufacturing. Coordinate resources required to complete routine work and assigned special projects in a timely manner. Manage manufacturing operations through SAP functions.
- 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 Bulk Adjuvant Manufacturing. Support the process for and troubleshoots process deviations and equipment failures.
- 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.
- Prior pharmaceutical production experience of 3 years, in vaccines OR biopharmaceuticals OR Food and a minimum of 3 years in a role leading cross functional teams.
- Demonstrated experience with delegating, training, evaluating, coaching and disciplining others.
- In lieu of this experience, completing the GSK graduate rotational program will be considered.
If you have the following characteristics, it would be a plus:.
- Supervising and managing production including aseptic technique, filling, and lyophilization, product visual inspection, input to scheduling and planning and regulatory compliance.
- The position requires the ability to travel internationally 10% of the time.
- Prior user experience with MS Project or similar project planning software.
- Knowledge of 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.
- Ability to lead 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.
- Ability to establish, maintain and supervise working relationships cross functionally.
- The ability to analyze data and implement change.
- Ability to lead 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.
- The ability to communicate effectively, both verbally and in writing, to all levels within the organization as well as the skills to communicate site operations to outside agencies.
- Familiarity with Good Manufacturing Practices and NIH guidelines.
- Ability to follow written procedures and document results in a neat and precise manner.
- Maintain a high level of integrity while balancing multiple priorities and responsibilities.
Our values and expectationsare 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, rigour 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).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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