At Nelson Laboratories, a Sotera Health Company, our employees are part of an industry-leading, global provider of laboratory testing and consulting services; dedicated to the mission of helping the best companies in the world improve the quality of life by providing the highest standard in laboratory testing.

Our employees receive competitive pay, growth and learning opportunities, insurance benefits, tuition reimbursement, paid holidays and PTO, and the opportunity to attend many company-sponsored employee and family events.

At Nelson Labs, it's whatwe do, as employee's, that makes the difference; so...we offer comprehensive training programs, mentorship, innovative lab practices, and a culture of employee collaboration.

Job Description:

The Pharmaceutical Quality Control Microbiologist is a consultative expert for clients and serves as an internal scientific expert and mentor for microbiology testing for routine and large projects and other testing requiring a high degree of consultation. The role requires a high level of customer service and a scientific background with experience in the pharmaceutical industry.

Key Responsibilities

• Develop strong relationships with the client, sales team, service center, and laboratory personnel to ensure the highest level of alignment and customer satisfaction
• Mentor, coach, and develop laboratory personnel
• Author and review test protocols, laboratory training, procedures, scientific marketing material and other sources of information
• Ensure that microbiology testing methods are up to date with compendial guidance, current industry practices and regulatory requirements
• Evaluate emerging technologies and work with team to develop business strategies
• Coordinate method development and testing with the internal microbiology laboratory for a wide variety of testing, e.g. filter efficacy, disinfection and preservative effectiveness, log reduction, microbial growth, ingress, microbial enumeration of non-sterile products, and antibiotic potency testing for clients in the Pharmaceutical and Medical Device industry.
• Ensure regulatory compliant practices are maintained in the laboratory.
• Evaluate technical challenges and lead implementations for corrective and preventive actions.
• Represent company on microbiology topics in presentations and during interactions with clients and regulatory agencies.
• Using Project Management principles and discipline, lead and participate on cross-functional teams to resolve issues.
• Other duties as assigned

Knowledge/ Education

• Required
  • BS/MS degree(Microbiology, Molecular Biology, Biochemistry, or a related science with significant microbiology)
  • 3-4 years Experience in Pharmaceutical QC Microbiology (cGMP/cGLP environment)
  • Direct consulting experience with the clients (verbal and written communication)
  • Direct experience interacting with regulatory agencies
  • Demonstrated knowledge and experience with USP/EU/JP, ISO/AAMI, CLSI standards
  • Demonstrated competency using soft skills to manage teamwork, change, conflict, and continuous improvement
• Strongly Preferred
  • CMC experience
  • Working knowledge of USP/EU/JP, ISO/AAMI, CLSI standards
  • Biofilm experience

Work Environment:

This job operates in a professional office and laboratory environment. Typically works in an office environment but may occasionally be required to perform job duties outside of the typical office setting. This role routinely uses standard office equipment such as computers, keyboards, computer mouse, telephones, photocopiers, projectors, and file cabinets. This position may also include laboratory, warehouse, or clean-room environment and applicable PPE. May occasionally walk on slippery or uneven surfaces.

Travel requirements.

Occasional travel during the business day. Some out-of-the area and overnight travel may be expected. May be required to attend trade shows, seminars and conferences in addition to sales travel.

Physical requirements:

Must be able to stand/walk for 10% of the day and 90% of the day sitting at a desk or on the computer.

Must be able to occasionally lift a maximum of 45lbs