Scientist I, Microbiology

About the Position:

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.

Qualifications:

• 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

Pay range is estimated between $70k - $83k based on skill set and experience.

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