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:
- Support in the set-up, development and optimization of GMP QC-Operations Laboratories, primarily launching and support Non-GMP and GMP AAV production.
- Support QC-Operations initiatives including equipment qualification, method development, method validation, and tech-transfer.
- Support method lifecycle initiatives. Author and/or review protocols, executions and reporting for developed methods.
- Perform a wide range of analytical tests, including but not, CE-SDS, AUC, ELISA, ddPCR, HPLC, and DNA Sequencing/Analysis
- Develop and lead optimization initiatives to improve QC and AD departments.
- Effectively communicate and present results, observations, solutions, and scientific strategies to internal and external stakeholders.
- Perform other duties, as assigned based on business needs.
- Up to 15% traveling to support CDMO projects or business development activities.
Qualifications:
- Master’s degree with 4 years of relevant work experience, or Bachelor’s degree with 7 years of relevant work experience.
- Degree in Molecular Biology, Biochemistry, or related scientific field. Experience in gene and cell therapy by way of Viral Vectors.
- Experience working with CE-SDS and/or AUC and/or SEC-MALS HPLC.
- Familiar with principles of Good Documentation Practices, Data Integrity, ALCOA+
- Experience following Standard Operating Procedures or protocols
- Strong interpersonal, verbal, and written communication skills.
- Experience as a trainer is a plus.
- Ability to problem solve, and work independently and as part of a team.
- Experience with Microsoft Office tools. Experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus.
Compensation: The salary range, dependent upon experience level, is $75,000 - $100,000 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.
