Associate Scientist, Microbiology

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. ProBio brings together multidisciplinary expertise to accelerate development and manufacturing through customized, comprehensive services. With established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing), ProBio serves global customers and has helped obtain more than 150 IND approvals since October 2017.

About the role

The position reports to the Microbiology Manager and 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 clinical trial materials, as well as participating in technology transfer. This role offers the opportunity to lead and evolve the QC-Microbiology function within a CDMO business, supporting a broad portfolio and advancing manufacturing capabilities to deliver transformative products for client projects.

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, including but not limited to:
  • Environmental Monitoring
  • Plate Reads
  • Water Testing
  • Gas Testing
  • Gram Staining
  • Growth Promotion
  • Bioburden
  • Gowning Qualifications
  • 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 the QC department.
• Perform other duties as assigned based on business needs.

Requirements

• Master’s degree with 1 year 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 and cleanroom activities.
• Experience in Mycoplasma testing or other cell culture and viral assays.
• Experience with documentation, including authoring, reviewing, and/or approving GMP documents such as procedures, test methods, protocols, and reports.
• Ability to problem solve and work independently as well as part of a team.

Pay

Pay range is estimated between $55k - $70k based on skill set and experience.

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Paid parental leave after three months of employment.
• Paid time off policy including 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.