Microbiology Scientist

Are you a Science Professional looking for a challenging opportunity to work with a highly energized team? If so, this could be a great position to explore.

As a Quality Control Microbiology Scientist, you will be responsible for testing drug product and drug substance samples for release, stability and in-process and/or - Sampling, testing, and releasing raw materials for production use. This role will perform environmental monitoring of the production areas. Must be able to work Weekend and off-shift coverage as required for Microbiology role.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Perform and train others on physical testing of laboratory samples (raw materials, drug product, drug substance, in-process, water, etc.) utilizing various chemical and biochemical techniques including Immunoassay, Separations, Compendial or various microbiological techniques and assays including Environmental Monitoring, Bioburden, and Endotoxin (see Section C for details).
• Prepare laboratory samples for analysis and prepares laboratory standards and solutions.
• Perform sampling and laboratory testing (instrumental and wet chemistry) of raw materials for quality disposition in support of manufacturing operations, technical transfers, and special studies within the product supply chain.
• Manage samples and associated documentation for duration of sample lifecycle, both physically and electronically.
• Participate in laboratory investigations.
• Author, review, and revise SOP’s and support Electronic Notebook template development (testing electronic lab notebook templates, author user requirement specifications, etc.)
• Reviews and approves laboratory data.
• Performs routine departmental GMP activities (lab instrument calibrations, preventive maintenance, audits, work orders, etc.)
• Support analytical and instrument lifecycle, technical transfer, and/or validation
• Laboratory upkeep and maintenance (5S, routine equipment/glassware cleaning, etc.)

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in scientific discipline
• 2 years experience of GMP
• 2 years experience with lab testing
• Microbiology experience

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Biopharmaceutical testing experience is preferred, ability to learn various techniques and assays. Assays include (but not limited to) – CGE, ELISA, CiEF, Bioassay, SEC, SPR, Protein Concentration, HPLC/UPLC, PCR
• Microbiological assays include (but not limited to) Bioburden, Endotoxin, Environmental Monitoring, Growth Promotion, Biological Indicators, Disinfectant Efficacy.
• System experience preferred – SAP/ERP, LES, Webstatistica, Empower, Hamilton (automated liquid handling), analytical instrument software (softmax, etc.)
• Experience with MS Excel, Word, PowerPoint
• Working knowledge of cGXP, ICH guidelines, FDA, USP/EP/JP and data integrity guidelines and regulations
• Weekend work and off-shift coverage is required for Microbiology role

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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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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