Position Overview:
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.
- Microorganism Analysis: Not limited to, activities such as Plate Reads, Gram Staining, Growth Promotion, Bioburden, Endotoxin, Gowning Qualifications, 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 0-2 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.
Please note that this role is based fully onsite in Pennington, New Jersey. The estimated salary range is $55,000 - $65,000 annually.
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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.
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Founded in 2002 and listed on the Hong Kong Stock Exchange in 2015, GenScript has an established global presence across Greater China, North America, the EU, and Asia Pacific. Today, over 300,000 customers from over 160 countries and regions worldwide have used GenScript’s premier, convenient, and reliable products and services. GenScript currently has over 5,000 employees globally, 33% holding master’s and/or Ph.D. degrees. In addition, GenScript has a number of leading commercial technologies developed in the fields of synthetic biology, immunotherapy, antibody design, chemical synthesis, and bioinformatics, including more than 100 patents and over 270 patent applications. As of June 2022, GenScript's products and services have been cited by 74,700 scientific papers worldwide. GenScript is committed to striving toward its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.
