QC Sr. Manager -Raw Materials

About GenScript

GenScript Biotech Corporation (Stock Code : 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific.

GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology

About ProBio

ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers.

ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.

In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China.

It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals.

In terms of viral vector service, ProBio has a stable and high-yield viral vector platform.

Position Overview :

The position reports to the Director of QC , 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.

• Lead in the set-up, development and maintenance of a GMP QC-Raw Materials system and laboratory.
• Lead QC-Raw Materials initiatives including equipment qualification, method development, method validation, tech-transfer, protocol execution, process development and optimization support.
• Collaborate with cross-functional teams to develop and validate new analytical methods in accordance with regulatory guidelines.
• Author, develop, and execute protocols related to QC-Raw Materials initiatives.
• Perform and oversee a wide range of analytical tests, including but not limited to, UV-Spectrophotometry, HPLC / UPLC, RAMAN, FTIR, and ICP-MS.
• Lead a team of analysts, providing guidance, training, and support.
• 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 :

Master’s degree with 4 years of relevant work experience, or Bachelor’s degree with 8 years of relevant work experience.

Degree in Molecular Biology, Biochemistry, Biology or related scientific field. Experience in gene and cell therapy recombinant plasmid DNA products a plus.

• Expertise working with QC intermediate and release testing. Experience working with HPLC / UPLC, FTIR, RAMAN, ICP-MS.
• Experience with Risk Assessment, Quality Management Systems, Investigations, and Audits
• Experience with governing regulatory bodies, such as FDA, ICH, and EU Annex 1. Experience with lab audits is a plus.
• Experience with documentation, by way of authoring, reviewing and / or approving GMP documents, such as procedures, test methods, protocols, reports, etc.
• Experience with Laboratory Information Management Systems (LIMS), or relevant data management software.
• Experience as a trainer is a plus.
• Ability to problem solve, and work independently and as part of a team.

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.