GSK

Senior Scientist- Microbiologist

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Posted
February 02 2021
Ref
278524
Organization Type
Pharma
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.

*LI-GSK

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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.

Similar jobs

Similar jobs