Senior Scientist- Microbiologist

Collegeville, PA
February 02 2021
Organization Type
Job Type
Senior Scientist
Are you energized by a highly impactful microbiology role that allows you to assist with implementation of modern microbiology methods and technology? ​ If so, this Microbiologist role could be an exciting opportunity to explore.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
  • Provide Scientific support for project teams.
  • Support facilities through environmental monitoring.
  • Assist with implementation of modern microbiology methods and technology.
  • Ensure data meets compendial and GSK quality Standards.
  • Co-ordinate or perform appropriate testing to support release of finished products or testing of stability samples for clinical product manufacture.
  • Review microbiological test results from in house or contract microbiological testing labs for completeness, accuracy, and quality, in addition to assessing trends to draw conclusions.
  • Work with UP microbiology team to define microbiological control strategies for drug products (both API and Formulations).
  • Support rapid microbiology technology evaluations in relevant areas to support Sterility testing, Environmental Monitoring, and Endotoxin testing.
  • Provide CMC regulatory submission support with respect to microbiology.
  • Provide direct or indirect support in authoring of regulatory submission sections and technical reports.
  • Transcription checking or review of microbiology data and submissions.
  • Maintain partnerships with clinical manufacturing and product development teams to provide timely and high-quality data and service.
  • Support project teams through clinical progression helping to deliver validated microbiological testing procedures.
  • Develop and propose specifications, sampling instructions, test methods, and other Quality Control Procedures.
  • Maintain Training records and familiarity with current SOPs and controlled documents.
  • Proactively seek assistance from other scientist to solve problems.
  • Work to GMP standards as appropriate.
  • Follow safe laboratory practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.
  • Support of internal business management audits as well as safety audits to ensure compliance with building and organizational policies within the microbiology laboratory.
  • Development and Implementation of new practices and procedures aimed at optimizing current procedures.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in a scientific or technical discipline (i.e. Pharmaceutical Sciences, Microbiology, Biology) with preference to having pharmaceutical experience in method development, validation and testing of API/drug products.
  • Experience with GMP laboratory operations and FDA regulations.
  • C ompendial knowledge of USP Microbiology.
  • Experience using root cause analysis and corrective action implementation.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Excellent verbal and written communication skills
  • Ability to prioritize and organize tasks.
  • A high level of learning agility.

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:
  • 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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