Scientist I, Microbiology

Legend Biotech USA; Pennington (NJ); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid parental leave

Paid time off, holidays

Job summary

GenScript USA Inc/ProBio Inc. seeks a QC Microbiology professional to support GMP manufacturing of clinical materials and technology transfer across a broad portfolio.

You will perform environmental monitoring, product testing, and method governance, ensuring cGMP compliance and contributing to lab optimization initiatives and cross-team collaboration.

Qualifications

• Bachelor's degree in Microbiology, Biology, Biochemistry or related field with 2-5 years of relevant work experience.
• Familiar with Good Documentation Practices and Data Integrity (ALCOA+).
• Experience following Standard Operating Procedures or protocols.
• Ability to solve problems and work independently and in a team.
• Experience with Microsoft Office tools.
• Strong interpersonal, verbal, and written communication skills.

Responsibilities

• Sample Collection and Environmental Monitoring of cleanrooms, water and gas testing.
• Support QC-Microbiology lab procedures and method governance.
• Support QC-Microbiology product testing and verification.
• Support media fills monitoring and testing.
• Microorganism analysis including plate reads, stains, Bioburden, endotoxin, mycoplasma.
• Participate in EMPQ, cleanroom validation, and related documents.
• Ensure cGMP compliance in QC testing activities.
• Assist optimization of lab inventory and workflows.

Skills

GMP/CGMP knowledge

GxP compliance

ALCOA+

SOP adherence

Problem solving

MS Office

Communication skills

Education

Bachelor's degree in Microbiology

Job description

About GenScript

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 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 - $85k based on skill set and experience.

Benefits:

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.