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.

Job Summary:

The Study Director has overall responsibility for the technical conduct of all assigned tests as well as for the review, interpretation, analysis, documentation, and reporting of results. The study director is the single point of study control. The study director ensures all assigned studies are completed on time.

A Consulting Study Director serves as a Subject Matter Expert (SME) both internally and externally for the testing they oversee and related industry regulations. A Consulting Study Director will represent well the testing they oversee both verbally and in writing. He/she may also be assigned supervisory responsibilities while in this role.

Education and experience requirements:

• 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 3-5+ 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

Essential Duties:

Scientific/General

• 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 Study Directors.

Regulatory & Compliance

• Address findings from internal and external/regulatory audits.
• Assist with CAPA assignments as needed.

Professional Development

• Teach internal/external Nelson training courses and seminars as assigned.
• Create content for scientific and trade journals.
• Participate in standards meetings as possible. Disseminate information to key staff members.

Customer Service

• Serve as a technical and scientific expert with on-site sponsor/sales visits.
• Assist with annual pricing review.

Project Management

• Coordinate with sponsors and other sections regarding test requirements for routine and non-routine studies.

Work Environment:

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.

Travel

Occasional local travel during the business day and occasional out of the area or overnight travel may be expected.

Physical requirements:

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.