Associate Scientist, Microbiology

GenScript/ProBio • Pennington, NJ

5d • $55,000 - $70,000 • Onsite

About The Position

The position reports to the Microbiology Manager, is ideally suited for a professional with extensive 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 lead and evolve 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.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level