Steve Groehnert

About Steve Groehnert

I have extensive Pharmaceutical experience and 25 years in management with a BS in Biology. My most recent experience is at Sanofi\'s and Minaris Microbiology department, but over the years of my career I have worked extensively in QA and QC. I have a strong work history including 14 years at Pfizer (formally Wyeth), 3 years at Teva and 6 years at Barr Labs with positions of increasing responsibilities, always working within the cGMP and FDA regulations. During my tenure at Pfizer, I have worked under a consent decree. This required a fast pace but compliant work environment to get the tasks at hand completed.I am knowledgeable in the following skills- Clean room and environmental monitoring - Laboratory management (Chemistry and Microbiology)- Investigations/CAPA/Remediation - Change Control Management - Lead Audits/resolved audit items - Lead process improvements - SOP revision/issuance/r••••••••@yahoo.com20••••••65

Experience

1. Senior Manager of Microbiology Lab (Cdmo)

   Minaris

   Apr 2025 — Present · Allendale, NJ, US

   Senior Manager of Microbiology and Environmental monitoring departmentManaging department of 26 people with 4 reports for Microbiology Laboratory operations. Oversee daily lab testing activities, aseptic gowning program, Environmental monitoring, SOP creation/revisions, Change controls, investigations. Managing Environmental Monitoring samples, incubation, analysis of EM plates. Including identification of any growth identified and data entry/analysis of EM, Air Sample particulate and room air pressure differentials Collaborated closely with technical development teams to development, qualification, and tech transfer into cGMP QC Involved with onsite audits both internal and external. Demonstrated leadership in driving effective communication, coordination, and collaboration across cross-functional groups including Manufacturing, MS & T/CMC, Quality, Process Development, Supply Chain, Warehouse, Training, Engineering/Facilities, EHS, and Finance Provided technical and managerial leadership, interfacing with key stakeholders to ensure timely manufacture and disposition of products to patients. Knowledgeable in budget planning, purchasing lab supplies, creating POs, head count addition/reduction, medical waste disposal. Optimized QC lab procedures for material and sample management, routine testing, and general lab practices to enhance testing accuracy and turnaround time. Over see sterility testing for the 7 day rapid testing using isolator technology and BacT instrument

Education

• Ramapo College of New Jersey

  Bachelor’s Degree, Biology

Skills

• Corrective and Preventive Action (Capa)
• Maximo
• 21 Cfr Part 11
• Technology Transfer
• Equipment Qualification
• Quality Assurance
• Aseptic Processing
• Chemistry
• Bioburden
• Glp
• Write/Revise Sops
• Investigation Writing
• Quality Control
• Gmp
• Trackwise
• Pharmaceutical Industry
• Sop
• Fda
• Microbiology
• Hplc
• Eams
• Laces/Lims
• Deviations
• Gas Chromatography
• Kiazen
• Uv/Vis
• Laboratory
• Potable Water Testing
• Biopharmaceuticals
• Endotoxin
• Good Laboratory Practice (Glp)
• Commitments
• 10 Hour Osha Overview Course
• Change Control
• Lims
• Mlt
• Lean Labs
• Swab Testing
• Malvern Particle Sizer
• Ftir