Associate Scientist, Microbiology

GenScript Biotech Corp.; New Jersey; On-site; USD 55,000 - 70,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Paid time off

Flexible spending account

Health savings account

Life and AD&D insurance

Job summary

GenScript Biotech Corp. in New Jersey is seeking a GMP QC-Microbiology Lab professional with a proven track record in development and transfer of processes for GMP manufacturing of clinical trial materials.

You will set up, develop, and maintain QC microbiology lab functions, perform environmental monitoring, mycoplasma testing, and other assays, while ensuring cGMP compliance and high-quality documentation in a fast-paced CDMO environment.

Qualifications

• 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 with Environmental monitoring, cleanroom activities.
• Experience in Mycoplasma testing or other cell culture and viral assays.
• Experience with GMP documentation, procedures, test methods, protocols, reports.

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, 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.

Skills

Environmental monitoring experience

Mycoplasma testing experience

GMP documentation experience

Problem solving

Education

Master’s degree in Microbiology or related field

Bachelor’s degree with 3 years relevant experience

Job description

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, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

About ProBio:

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. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017

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.

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.

Qualifications:

• 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.

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

#AH

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.