- King of Prussia, PA
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: May 14 2020
Are you interested in integrating 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 gowning and investigations
- Has knowledge of cGMP requirements and ability to generate high quality data
- Has some computer application experience (i.e., database use and management)
- Master's degree in Microbiology, Biology, Immunology, Biotechnology or related majors
- At least 3 years practical laboratory experience
- Demonstrates good communication skills
- Has ability to work effectively with a team and able to work independently
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, 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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