Veterans Preferred - Senior Microbiology Specialist/Lead

Rockville, Maryland, US
Sep 14, 2021
Sep 16, 2021
Biology, Energy
Employment Type
Full time
Salary Type
Military Veterans are Encouraged to Apply.
GSK is currently looking for a Sr. Microbiology Specialist to join our team in Rockville, MD. The Sr. Microbiology Specialist supports management of laboratory operations, lab testing, and technical transfers associated with GSK production facilities. In addition, the job holder has expertise in at least one area of QC Microbiology, and provides guidance, training, and sharing of knowledge to personnel within the group and across departments.
KEY RESPONSIBILITIES: •Is a SME for specific tasks required by the team (EM, Clean Utility testing, bioburden, endotoxin, microbiological identification, etc.) •Revises and authors procedures (SOPs and WIs) for clarity and accuracy •Authors protocols and reports supporting implementation of new methods, media and or equipment/rapid automated technologies •Completes daily assigned routine tasks timely and accurately (may include collection and/or testing of GMP samples, reporting of data, general lab housekeeping) •Paperwork review, data entry, filing, etc. •Generation of data reports and/or trends in support of regulatory requirements and deliverables •Leads and/or serves on cross-functional team projects as needed, project manager for Microbiology-driven projects •Provides training to staff •Reviews and approves microbiological test results for environmental monitoring, raw materials, bulks, finished products, growth promotion, and validation testing. •Supports initiatives to improve Quality, overall laboratory efficiency and GMP performance •Authors microbiological investigations, change controls, protocols, and validation reports. May support by coaching and review the laboratory investigations of other analysts. •Writes, updates, reviews, and approves Laboratory Standard Operating Procedures, Analytical Methods and Specifications and troubleshoots laboratory test problems. •Assesses new microbiological technologies for application to site operations and lead and coordination of implementation efforts •Assures that laboratory equipment is calibrated and in good working condition, assists in selection and purchasing supplies and equipment. •Utilizes GPS/lean tools and processes to continuously improve efficiencies and ensured adherence to schedule. •Responsible for ensuring laboratories are operated in a state of control with regards to current LSOP's, housekeeping and safety requirements, GMP's and regulations and Microbiological SME for internal and external regulatory audits and inspections.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

  • BA/BS in a scientific discipline
  • 5+ years industrial experience in biopharmaceutical industry, such as Microbiology, Biology, or related field experience.

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

• Highly regulated and complex environment experience.
• Ability to effectively manage workload and meet timelines.
• Strong technical writing and problem solving skills preferred.
• Strong communication and leadership skills.
• Quality Assurance experience preferred.
• Biopharmaceutical manufacturing experience preferred.

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

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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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