Scientist I, Microbiology

The position reports to the Manager of Microbiology, is ideally suited for a professional with technical knowledge, and a proven track record of developing and carrying out processes, that are suitable for use in GMP manufacturing of a wide range of clinical trial materials, and participating in the technology transfer. There is a great opportunity to learn this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.

Responsibilities

Sample Collection and Processing: Environmental Monitoring of cleanrooms, Water Testing, and Gas Testing; Support QC-Microbiology laboratory procedures: development and updating of governing procedures and methods; Support QC-Microbiology Product testing: routine testing on products, verification testing on products, method suitability, training, development, updating of governing procedures and methods for product testing; Support QC-Microbiology media fills: monitoring and testing of media fills; Microorganism Analysis: Not limited to, activities such as Plate Reads, Gram Staining, Growth Promotion, Bioburden, Endotoxin, Gowning Qualifications, mycoplasma, plasmid retention, Biological indicators, aseptic training, and other QC-Microbiology activities; Participate in EMPQ, cleanroom validation, and associated activities/documents; Responsible for following cGMP in carrying out functions related to QC testing; Support optimization initiatives to improve QC department, such as lab inventory, sample workflow, and lab preparation; Perform other duties, as assigned based on business needs

Requirements

Bachelor's degree in Microbiology, Biology, Biochemistry or related scientific field with 2-5 years of relevant work experience; Familiar with principles of Good Documentation Practices, Data Integrity, ALCOA+; Experience following Standard Operating Procedures or protocols; Ability to problem solve, and work independently and as part of a team; Experience with Microsoft Office tools; Strong interpersonal, verbal, and written communication skills

Benefits

Medical, dental, and vision insurance; 401(k) retirement plan with a company match that vests fully on day one; Paid parental leave after just three (3) months of employment; Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays; Flexible spending and health savings accounts; Life and AD&D insurance; Short- and long-term disability coverage; Legal assistance; Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance; Commuter benefits; Well-being initiatives; Peer-to-peer recognition programs