Microbiologist Lead

GSK is currently looking for a Microbiologist Lead in Rockville, MD. The Microbial Control Lead will be responsible for leadership, management, and implementation of the Contamination Control Programs, incl. Microbial Control strategy. The role will lead and engage in Quality Risk Management (QRM) initiatives designed to develop a robust microbial control strategy, support investigation related to such contaminations, and ensure robust knowledge deployment around microbial risks and controls and training for personnel behaviors and aseptic techniques.

This is a single contributor role which will work closely with stakeholders in Operations, Quality, Engineering, Validation and Facilities. This role is matrix leader role, part of the Quality Leadership Team and serve as an SME at Rockville Biopharma.

Key Responsibilities:

• Responsible to establish and maintain microbial controls program ensuring that overall quality standards around microbial risks and controls are met.
• Lead, facilitate, write and/or approve on risk assessments for microbial controls and contamination investigations.
• Write the Contamination Control Strategy for the facilities and ensure periodic review
• Lead cross-functional teams through complex issues and challenges.
• Provide coaching and mentoring to contamination investigation teams.
• Ensure well written contamination investigation reports.
• Partner with training team and / or relevant SMEs to develop and deliver training solutions and build capabilities at site associated to microbial risk and controls, as well as clean room behaviors and aseptic techniques
• Participate in Quality Council and holistically assess and report, with cross-functional team, microbial trends from the various quality systems.
• Critically analyze data to recommend opportunities for robustness improvements.
• Implement endorsed projects to drive to desired future state (where applicable use of quality system workflows change control, CAPA, Quality Improvement Plan may be employed).
• Support new product transfers as the microbial contamination control expert.
• Support new product/new process/new equipment design for microbial control and support microbial risk assessments for new products and processes
• Support Quality Control team as needed to develop EM program and testing.
• Support Facility and Operations as needed to develop Cleaning and Disinfection program.
• Supports Operations as needed to develop Gowning and Qualification program including aseptic techniques.

Basic Qualifications:

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

• BS/BA degree including 8+ years OR MS or Ph.D degree including 5+ years of sterile pharma, biopharmaceutical or biologics industry-based experience
• Experience with Process Microbiology (risk assessment), Contamination Control, Sterility Assurance systems, Quality Control Microbiology or Quality Assurance or Operational Quality or MSAT

Preferred Qualifications:

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

• Excellent technical writing skills and high attention to detail
• Knowledge in cGMP, CFR and other regulations in order to assure GMP compliance.
• Working knowledge of microbial risk assessments HACCP / FMEA is desirable
• Demonstrated knowledge of Quality by Design and risk management approaches
• Track record of improving products, processes and troubleshooting, execution of technical activities including trials and validation activities
• Demonstrated self-starter with strong self-management, written and oral communication skills with a proven ability to articulate complex, technical details to stakeholders throughout the organization.
• Strong organizational skills, data analysis, and strong computer skills.
• Good verbal and written communication ability and team oriented with strong interpersonal skills.
• Demonstrated self-starter with strong self-management, written and oral communication skills with a proven ability to articulate complex, technical details to stakeholders throughout the organization.

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