Microbiologist

Description

What You Will Achieve:

• You will be at the center of our operations, and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality.
• Your work in the Analytical R&D Microbiology Strategy & Testing organization helps enable development of biological therapeutics at Client.
• Your responsibilities will be applying GMP microbiological methods (bioburden, endotoxin, etc.) in the assessment of product quality and detection of impurities.
• Your contributions are part of a group performing microbiology identification, testing, and method qualifications to support multiple sites in the Client network.
• You will be responsible for Environmental Monitoring (EM) of manufacturing facilities, waters, and compressed gases at the site. Responsible for utilizing established microbiological methodologies to support GMP in-process and research & development testing of clinical supplies.
• You will become proficient in aseptic lab technique and facility gowning to thrive in this fast-paced environment.
• Your strong foundation in general scientific practice, its principles and concepts will help in meeting critical deadlines.
• You will be relied on as a technical contributor to assess the assigned tasks and make decisions that involve direct application of your knowledge.
• It is your focus and commitment that will help in making us ready to achieve new milestones and help patients across the globe.

How You Will Achieve It:

• Exercise and build basic team effectiveness skills {e.g., commitment, feedback, consensus management) within the work group.
• Review and contribute to technical documents, including validation protocols and reports, analytical test procedures, investigation reports, monitoring trend reports, and change controls.
• Directly interact with multiple department team members, including presentation of data.
• Complete all Good Laboratory Practice {part of GxP} and safety training in compliance with departmental requirements and follow appropriate safety practices in the workplace.
• Perform various experiments for microbial analysis, qualification/validation, and characterization of biological therapeutics.
• Perform and document environmental monitoring of manufacturing areas and related Microbiological activities.
• Conduct all work according to appropriate Standard Operating Procedures following Good Manufacturing Practices/Good Laboratory Practices (GMP/GLP) requirements and ensure integrity of all data generated and documented.
• Independently analyze and provide conclusions regarding data generated.
• Plan and prioritize assigned testing activities.
• Present problems and propose solutions in discussions with group members.

Education & Experience

Must-Have

• Bachelor's Degree in microbiology, biochemistry, biology, or related field
• Good documentation skills with high attention to detail
• Strong organizational skills and effective interpersonal and written communication skills
• Be self-motivated and highly effective in a team-based environment
• Ability to follow established procedures under minimal supervision

Nice-to-Have

• Experience with Quality Systems in a Good Manufacturing Practices (GMP) environment
• Experience with laboratory data systems such as Laboratory Information Management Systems (LIMS)
• Hands on experience or working knowledge in pharmaceutical industry and handling of analytical instruments
• Some knowledge of drug development process for progression of biological candidates
• **Environmental monitoring of ISO 7 and ISO 8 manufacturing areas, reading plates, qualifying media plates, TOC & Conductivity testing, kinetic endotoxin testing, water & pharma gas sampling and testing, and other general support for the laboratory.
• Good lab safety awareness and a good foundation in microbiological testing.
• Prefer experience of working within a GMP framework with particular regard to manufacturing environments.

Required:

• Environmental Monitoring Aseptic Techniques
• Bachelor's Degree in microbiology, biochemistry, biology, or related field
• Good lab safety awareness and a good foundation in microbiological testing.