Sr Scientist

King of Prussia, PA
April 07 2021
Organization Type
Are you interested in integrating into a Microbiology, Systems and Analytical Services (MSAS) group that is responsible for supporting the Manufacturing Process of sterile filling operations for both small and large molecule R&D clinical supplies? If so, this role might just be for you.

As a Microbiology Senior Scientist supporting Sterile Manufacturing, you will have an opportunity to provide hands-on sterility assurance and microbiological laboratory support for a pilot plant for the production of R&D parenteral clinical supplies in GSK's portfolio.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Provide expertise in microbiological control of materials, processes and people for sterile clinical supply manufacturing in accordance with GMP requirements and corporate policies and standards.
  • Contribute to the development and implementation of quality and facility systems where they relate to microbiological design and safety
  • Oversee and develop improvements in training for sterility assurance of operators (contamination control, aseptic practices, gowning, gloving)
  • Interfaces with intra- and inter-departmental contacts to convey sterility assurance aspects of manufacturing
  • Recognize, communicate and lead investigation of aberrant microbiological test results or trends
  • Write microbiological and contamination control methods/SOPs regarding sterility assurance where required
  • Write validation protocols and implement validation on instrumentation and test methodology, where appropriate
  • Investigate new technology in microbiological testing where appropriate
  • Perform, when appropriate, additional Quality Control activities, including
  • Environmental monitoring to support non-sterile and sterile areas and operations personnel
  • Routine bioburden testing on raw materials and finished product, e.g., microbial enumeration, sterility testing, selected species testing
  • Bacterial endotoxin testing on pharmaceutical water system samples, raw materials and finished products
  • Identifications of microbial isolates
  • Approving test results that support release of finished products and stability programs
  • Ensuring that all necessary testing is performed and evaluated against specifications for drug products that will be used in the clinic

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in Microbiology, Biology, Immunology, Biotechnology or related majors
  • Recent experience in aspects of sterility assurance including contamination control, gowning and investigations
  • Has knowledge of cGMP requirements

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Master's degree in Microbiology, Biology, Immunology, Biotechnology or related majors
  • At least 3 years practical manufacturing support or laboratory experience
  • Demonstrates good communication skills
  • Has ability to work effectively with a team and able to work independently
  • Has some computer application experience (i.e., database use and management)
  • Ability to generate high quality data

Why GSK?

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:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.

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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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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