3M is seeking a Microbiology Lab Team Leader for the Medical Solutions Division, located in Columbia, MO. At 3M, you can apply your talent in bold ways that matter. Here, you go.
Job Summary :
The person hired for the position will lead and coordinate microbiology lab activities, including overseeing and performing testing, at the site. The person will also participate in the global Environmental Monitoring team and effort for the Division.
This position provides an opportunity to transition from other private, public, government or military environments to a 3M career.
include but are not limited to the following:
- Bioburden and microbial limits testing for release of products.
- Plant-wide environmental monitoring.
- Planning and prioritization of lab activities.
- Oversight of protocols, studies, summary reports, SOPs and other lab-related documents.
- Mentoring Micro Lab personnel.
- Coordinating 3M microbiologists and contract analysts in the lab, day-to-day work.
- Leading cGMP Compliance, troubleshooting and investigations within the Micro Lab.
- Consulting with teams and quality engineers for division projects requiring Micro analytical support.
- Collaborating with other groups and divisions to achieve quality objectives.
- Collaborating with labs in manufacturing plants.
- Working with contract laboratory staff, and interface with outsource labs as needed.
- Other duties as assigned.
- Possess a Bachelor’s degree or higher in a science or engineering discipline (completed and verified prior to start) from an accredited institution
- Minimum of three (3) years bench experience in a Micro Lab
- Minimum of five (5) years of combined Good Manufacturing Practice (GMP) experience in a private, public, government and/or military environment
- Minimum of three (3) years Micro method development and validation experience
- Bachelor’s degree of higher in Microbiology or related discipline from an accredited institution
- Minimum of ten (10) years of bench experience in a Microbiology lab
- Minimum of ten (10) years Good Manufacturing Practice (GMP) experience
- Minimum one (1) year of team leadership experience
- Quality Control (QC) experience in pharmaceutical manufacturing a distinct plus
- Experience with new technologies applicable to Micro testing
- Working knowledge of data collection systems conformance to 21 Code of Federal Regulations (CFR) Part 11
- Experience with Drug Quality Systems required for the QC laboratory
- Good organizational skills, attention to detail, compliance behaviors
- Experience as member with multi-disciplinary project teams
- Experience or familiarity with 5S (Japanese quality improvement philosophy) and/or lean manufacturing concepts
- Certified Six Sigma Green Belt (or willingness to obtain)
- Experience with analysis of Drug, Combination Product and Medical Device products
- Knowledge and Understanding of United States Pharmacopeia (USP), International Organization for Standardization (ISO), Food and Drug Administration (FDA) Guidance and/or International Council on Harmonization (ICH) relevant to Drug/Medical Devices for Microbiology as well as other international regulations.
- Excellent communication skills (oral, written and presentation)
May include up to 2 0% domestic
Must be legally authorized to work in country of employment without a sponsorship for employment visa status (e.e. H1B status).