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Apply online for the Filling / Lyo Manufacturing Supervisor position and advance your career in the Pharmaceutical industry today.
Filling / Lyo Manufacturing Supervisor : MedImmune
Job Number 57467
Employee Type Full Time
Company Name MedImmune
Location Marietta
Pennsylvania
Salary (year)
Experience 6 to 9 Years
Start Date 1/19/2010
Industry Pharmaceutical
Job Type Pharmaceutical-Manufacturing
Relocation Required
MedImmune  
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Description
Basic Qualification
If you believe you can be successful in a challenging start-up manufacturing environment with a global organization and possess all of the following minimum qualifications, we encourage you to apply immediately:

• BS or BA in a relevant technical discipline. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
• Minimum of 7 years prior pharmaceutical production experience in vaccines or biopharmaceutical industry.
• 5 years in a manufacturing supervisory role leading cross to include supervising and managing pharmaceutical production including aseptic technique, filling, and lyopolization, input to scheduling and planning, regulatory compliance.
• Previous managerial experience to include delegating, training, communicating and prioritizing site objectives, evaulating, coaching and discipling others.
• Demonstrated experience with leading PQ activities to include developing and executing PQ protocols, writing PQ summary reports and launching commercial product according to established timelines.
• Demonstrated experience with technical transfer and change over manufacturing processes.
• Fully versed in GMP’s, NIH and WHO Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance.
• Demonstrated ability to exhibit: flexible thinking; a willingness to develop oneself and others; the ability to build and maintain relationships; be customer focused; enable and drive change in an dynamic work environment; and exhibit a continuous improvement mindset.
• Demonstrated interpersonal and leadership skills. The ability to function within team based organization.
• Computer skills in Microsoft Office applications and the ability to quickly and easily learn new applications.
Details
GSK Biologicals, N.A. with our global quest to improve the quality of human life by enabling people to do more, feel better and live longer, is seeking a Filling / Lyo Manufacturing Supervisor for our vaccine manufacturing facility in Marietta, PA.

The Filling / Lyo Manufacturing Supervisor will supervise the day to day activities of manufacturing operators performing aseptic vial filling, lyophilizing, capping and vial inspection, controlled area sanitizations, decontamination of live virus materials, component preparation, vial washing, sterilization and depyrogenation activities to meet required quality, compliance and delivery targets of process validation lots and commercial products. Additional responsibilities include:

• Ensure manufacturing operations are executed in cGMP compliant manner and complies with company conformance standards and all applicable regulations.
• Assure safe, compliant and efficient operations of assigned production areas by ensuring all supervised personnel are adequately trained and perform routine inspections.
• Lead and coordinate cross functional teams and resources, internal and external, required to complete routine work and assigned special projects in a timely manner.
• Manage manufacturing operations through SAP functions.
• Coordinate efforts with QA regarding release of in-coming materials / components and materials manufactured.
• Participate in audits and investigations and recommend solutions to resolve problems.
• Lead process for and troubleshoots process deviations and equipment failures.
• Develop and implement productivity improvement plans using Industrial Excellence methodologies.

GSK Biologicals in Marietta is a beautiful community located along the Susquehanna River in Lancaster County, Pennsylvania. Our employees enjoy the proximity to larger metropolitan areas and benefit from more affordable housing, excellent school systems, and access to a multitude of recreational activities and the more relaxed lifestyle that the area has to offer.
Requirements
Preferred Qualification
Additionally Preferred candidates will possess:

• Prior experience with SAP in an pharmaceutical manufacturing environment.
• Experience with a facility start-up in order to create, lead and design applicable systems preferred.
• Lean Six Sigma Training/Certification.

GSK Biologicals, N.A. is committed to being the Best Place for the Best People to do their Best Work. This is accomplished through our Total Reward competitive compensation package, our employee performance and development planning and our diverse, challenging, and innovative work environment.
Contact Info
Apply online at company website
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