Director Assay Development Jobs in Minnesota (NOW HIRING)

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

Job Description:
• Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits).
• Conducts sample preparation for Sponsor materials as directed by study protocols for in vivo and in vitro biocompatibility assays, pharmacology studies, and toxicology studies.
• Performs the extraction process on prepared samples in accordance with ISO, USP and JMHLW regulations as directed by study protocols for biocompatibility assays.
• May prepare and maintain sterile glassware for the In-vitro lab and sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed.
• Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized.
• Performs preparation of media/reagents, maintains reagents and/or test article as required for testing, and maintains lab supplies/inventory.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management or Study Directors as required.
• Maintains an efficient and clean work area by organizing and restocking the sample preparation lab as needed.
• Communicates with external clients in regards to particulate observations or article abnormality. Routinely communicates with Study Directors, Quality Assurance and NAMSA Associates about issues, results, or audits.
• Responsible for daily monitoring of laboratory equipment, being on-call and responding to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• Performs ethylene oxide processing of study-related materials through the in-house sterilizer.
• Adheres to established company processes.
• Completes chain of custody documentation for test article tracking.
• Responsible for performing routine equipment microbiological monitoring.
• Maintains ancillary records (logbooks, worksheets).
• Communicates test schedule updates to NAMSA Associates or management as needed.
• Responsible for the assessment and completion of GLP study article data retention/archival.
• May assist in receipt and release of lab supplies and inventory.
• May assist trainers or may become a certified trainer to provide Associates with on the job training for basic lab tasks and media preparation.
• Other duties as assigned.
Qualifications & Technical Competencies:
• Experience in a GLP laboratory setting preferred.
• Basic mathematical knowledge is essential for surface area/volume ratio calculations that are part of the sample preparation process.
• An Associate or Bachelor degree in related scientific field is required. Individuals with sufficient relevant work experience may be considered at the discretion of management.
** Future openings at NAMSA (Talent Building Community)
Working Conditions:
• While performing the duties of this job, the Associate is occasionally exposed to sharps and hazardous or caustic chemicals. The noise level in the work environment is usually moderate. Eye protection is required in designated areas and when performing specific tasks. The Associate is occasionally exposed to small laboratory animals and may, on rare occasions, be exposed to blood borne pathogens and zoonotic diseases.
• While performing the duties of this job, the Associate is regularly required to stand; walk; reach with hands and arms; use hands to finger, handle, or feel objects, tools, or controls; talk; and hear. The Associate is occasionally required to sit, climb, balance, stoop, kneel, crouch, or crawl. The Associate must occasionally lift and/or move up to 50 pounds. The Associate may be required to view computer monitors and stand for extended periods of time.
Pay Range Minimum:
$14.81
Pay Range Target:
$20.00
Pay Frequency:
Hourly
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.