Job Scope:
The position reports to the Sr. QC 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
- Oversee GMP manufacturing facility consisting of design, construction, validation of facility, and supply chain system and operations.
- Oversee the preparation and management of complex GMP manufacturing facility development plans, budgets, and long-range planning
- Perform a wide range of analytical tests, including but not, UV-Spectrophotometry, qPCR, ELISA, HPLC, Endotoxin, MicroBCA, Electrophoresis, and DNA Sequencing/Analysis.
- Support QC-Analytics initiatives including equipment qualification, method development, method validation, and tech-transfer. Execute protocols related to QC-Analytic initiatives.
- Ensure compliance with cGMP and regulatory requirements.
- Develop and lead optimization initiatives to improve QC department.
- Responsible for following cGMP in carrying out functions related to QC testing.
- Perform other duties, as assigned based on business needs.
Qualifications:
- Bachelor’s degree in Molecular Biology, Biochemistry, Microbiology or related scientific field with 1-2 years of relevant work experience (Experience in gene and cell therapy recombinant plasmid DNA products a plus).
- Experience working with QC intermediate and release testing, raw material testing, or validation testing.
- Experience working with Electrophoresis, UV-Spectrophotometry, HPLC, qPCR, ELISA or DNA Sequencing/Analysis.
- Experience testing plasmid DNA. Experience testing viral vectors is a plus.
- 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. Emphasis on the ability to work in a team atmosphere.
- Experience with Microsoft Office tools. Experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus.
- Strong interpersonal, verbal, and written communication skills.
- Exposure to documentation life cycle, by way of authoring, reviewing and/or approving GMP documents, such as procedures, test methods, protocols, reports, etc.
Compensation: The salary range, dependent upon experience level, is $50,000 - $70,000 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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What We Do
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.
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