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Clinical Lab Manager

Eagan, MN
Purpose: The Clinical Lab Manager will be responsible for the start-up and operation of an already existing SPF testing laboratory. The laboratory is fully functional for in-vivo SPF testing, but SPF testing has not yet been implemented. The Clinical Lab Manager will also be expected to expand the scope of the clinical lab from in-vivo SPF testing to other appropriate areas of clinical testing, such as: skin irritation test, skin moisturization evaluation, etc.

Responsibilities
· Recruit test subjects for in-vivo SPF testing
· Establish a test subject database
· Perform the actual in-vivo SPF tests according to the FDA protocol
· Operate, validate, and maintain a Multi-Port Solar simulator
· Maintain accurate, up to date and concise test records
· Perform daily/monthly instrument calibration
· Keep abreast of new equipment and testing techniques
· Participates in the interviewing, hiring and evaluation of clinical staff
· Schedules and assigns work and sets work priorities as needed
· Assists in developing and facilitation orientation programs and training of new employees
· Other duties as assigned
 
Requirements
· Bachelors with 10 years of relevant working experience; OR Masters with 3-5 years of relevant working experience; preferred areas of study include Biological, Physical or Material Sciences, Chemical Engineering, or related fields;
· Minimum 3-5 years of experience in regulatory or OTC product testing within cosmetics, chemicals or pharmaceutical industries
· Knowledge of US/ international cosmetics and OTC regulations.
· Knowledge and experience with clinical testing, preferably with in-VIVO SPF testing
· Knowledge and experience with test subject recruitment
· Ability to independently collaborate and negotiate with vendors
· Project management experience with multiple projects and varying priorities
· Strong interpersonal skills. Must be able to interact successfully with all levels of personnel within R and D and with other divisions and departments, both written and verbal
· Capable of working in a strong teamwork environment a must;
· Computer proficiency: Excel, Power-Point, Word, Outlook
· Statistical analysis/interpretation
· Scientific writing/ report writing
· Experience with cosmetics, skin care and personal care products
 
Mark Underwood
Practice Associate 
615.988.9707
Frank CPG
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