Associate Scientist, Microbiology
GenScript/ProBio•Pennington, NJ
•$55,000 - $70,000
About The Position
The position reports to the Microbiology Manager. It is ideally suited for a professional with extensive technical knowledge and a proven track record of developing and carrying out processes suitable for GMP manufacturing of a wide range of clinical trial materials, and participating in technology transfer. There is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to client projects that transform the lives of patients.
Requirements
- Master’s degree with 1 years of relevant work experience, or Bachelor’s degree with 3 years of relevant work experience.
- Degree in Microbiology, Molecular Biology, Biochemistry, or related scientific field.
- Experience in gene and cell therapy recombinant plasmid DNA products a plus.
- Experience with Environmental monitoring, cleanroom activities.
- Experience in Mycoplasma testing or other cell culture and viral assays.
- Experience with documentation, by way of authoring, reviewing and/or approving GMP documents, such as procedures, test methods, protocols, reports, etc.
- Ability to problem solve and work independently and as part of a team.
Responsibilities
- Assist in the set-up, development and maintenance of a GMP QC-Microbiology Lab.
- Participate in EMPQ, cleanroom validation, and associated activities/documents.
- Responsible for following cGMP in carrying out functions related to QC testing.
- Functions may include, but not limited to, activities such as Environmental Monitoring, Plate Reads, Water Testing, Gas Testing, Gram Staining, Growth Promotion, Bioburden, Gowning Qualifications and other QC-Microbiology activities.
- Testing of compounded sterile and non-sterile pharmaceuticals
- Assist laboratory personnel in daily activities to maintain quality and compliance with SOPs, cGMP protocols, and safety standards.
- Conduct mycoplasma testing and various virology and microbial assays
- Demonstrate the ability to learn new skills and achieve proficiency
- Support optimization initiatives to improve QC department.
- Perform other duties, as assigned based on business needs.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
