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.
It's What We Do that's important, so...we offer comprehensive training programs, mentorship, innovative lab practices, and a culture of employee collaboration.
The study lead has overall responsibility for the technical conduct and coordination of activities and processes of assigned microbiological studies such as bioburden, antimicrobials and endotoxin determination. They direct the execution of studies according to FDA regulations and international standards. Responsibilities include review, interpretation, analysis, documentation and reporting of results. They are the single point of study control and ensure assigned studies are completed on time. Study leads work with lab analysts to direct activities for completion of studies and interact with quality assurance to ensure they are done with the highest quality and technical standards.
This position offers opportunity for progression to levels II and III as study leads develop to be subject matter experts (SMEs) and represent the testing they oversee in the industry.
If you have project management skills, good verbal and writing communication skills, a high level of initiative, quick learning skills and can strive in a high-paced environment, this position is for you!
Education and experience requirements:
*We have openings for multiple levels of Microbiologist:
- A.A. /A.S. and two years relevant experience performing testing operations within a Scientific Department
- Or, B.S. degree (microbiology or biological science strongly preferred)
- Ph.D. (life science strongly preferred) and one year of relevant experience leading testing operations within a Scientific Department or
- B.S. or M.S. degree (life science strongly preferred), and 1-5+ years leading laboratory studies and communicating with external clients/sponsors
- Technical Writing - ideally drafting documents and templates used by internal laboratory staff as well as summaries delivered to outside
- Project Management
- Client communication background
- Ensure procedures and reports are current with published methods.
- Ensure final reports accurately reflect the data, results and conclusions of the testing.
- Prepare and review written procedures including SOPs, STPs, PDSs, SDSs, etc.
- Ensure method validation and test controls are adequate to support the test methodology.
- Ensure sample and data traceability are maintained throughout testing.
- Ensure calculations and statistics accurately reflect the raw data.
- Ensure test controls and monitors are accurately recorded and reviewed.
- Be the subject matter expert (SME) on assigned standards and apply them appropriately to laboratory testing.
- Identify and resolve complex scientific problems.
- Actively participate in business strategies specific to section (as needed).
- Own section test method and equipment validations, including procedure development.
- Train and mentor Lab Analysts and other Study Leads in the future.
Regulatory & Compliance
- Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc).
- Know and follow company policies and procedures.
- Ensure that test procedures are approved and followed.
- Ensure all data are accurately and concurrently recorded.
- Ensure unforeseen circumstances or events are recorded and that corrective action is taken.
- Address findings from internal and external/regulatory audits.
- Assist with CAPA assignments as needed.
- Participate in standards meetings as possible. Disseminate information to key staff members.
- Create content for scientific and trade journals.
- Serve as a technical and scientific expert with on-site sponsor/sales visits.
- Assist with annual pricing review.
- Keep current with technical and scientific information.
- Ensure support personnel have adequate knowledge and training to perform their job functions.
Nelson Laboratories Departments of Testing:
- Product Sterility
- Bacterial Endotoxin
- Protective Barriers
- Analytical Chemistry
- Routine Chemistry
- Healthcare Reprocessing
- Antimicrobials and Filtration
This job operates in a professional laboratory environment. This role routinely uses standard office equipment and lab equipment including but not limited to computers keyboards, computer mouse, telephones, photocopiers, file cabinets, microscopes, micropipettes, pipette aids, various hand tools, and analytical equipment.
The possibility exists for exposure to biological and chemical hazards, exposure to carcinogenic compounds and other environmental aspects which may be considered unfavorable. Employees are expected to follow Biosafety and Chemical Hygiene policies, practices and procedures.
Occasional local travel during the business day and occasional out of the area or overnight travel may be expected.
The physical demands described here are a representative of those that must be met to perform the essential job functions.
- Requirements to stand and traverse to various office and lab locations and sit at a computer workstation will vary.
- Bending, stooping, and crouching.
- Occasional push and pull tasks with one or both hands.
- Must be able to work while wearing personal protective equipment such as safety glasses, goggles, face shields, gloves, lab coats and personal protective equipment deemed necessary to protect testing and to protect employees from various solutions, wastes, etc.
- Must be able to lift up to 45lbs.