QC Scientist - Microbiology

ZipRecruiter; uMdoni Local Municipality; On-site; ZAR 30 000 - 60 000; Full time

Job summary

An established industry player is seeking a skilled professional to lead quality control efforts in a GMP microbiology lab. This role involves developing and maintaining laboratory procedures, ensuring compliance with cGMP standards, and supporting diverse projects in a collaborative environment. The ideal candidate will possess a strong educational background in microbiology or related fields, along with hands-on experience in lab optimization and documentation. Join a forward-thinking company committed to enhancing health through biotechnology and make a meaningful impact in the field of gene and cell therapy.

Qualifications

• Master's or Bachelor's degree in relevant fields with experience in QC.
• Proficiency in GMP documentation and lab optimization.

Responsibilities

• Establish and maintain a GMP QC-Microbiology Lab.
• Ensure compliance with cGMP standards during QC testing activities.
• Support continuous improvement initiatives within the QC department.

Skills

Problem-Solving Skills

Communication Skills

GMP Documentation

Microbiology

Molecular Biology

Biochemistry

Education

Master's Degree in Microbiology

Bachelor's Degree in Microbiology

Tools

Laboratory Information Management Systems (LIMS)

Job description

Job Description

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group founded in 2002, with a presence across North America, Europe, Greater China, and Asia Pacific. Our businesses include gene synthesis technology, life science CRO services, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

Our vision is to be the most reliable biotech company in the world, making humans and nature healthier through biotechnology.

About ProBio

ProBio offers end-to-end CDMO services from drug discovery to commercialization, specializing in cell and gene therapy (CGT), vaccines, biologics, and antibody drugs. We support clinical and commercial manufacturing, including plasmid and virus CMC for IND filings. We have supported numerous approvals for CGT drugs and mRNA vaccines, with a high-yield viral vector platform.

Job Scope

This role reports to the Director of QC and is ideal for a professional with extensive technical knowledge and experience in GMP manufacturing processes for clinical trial materials. The position offers leadership opportunities within a CDMO setting to support diverse projects and enhance manufacturing capabilities.

Key Responsibilities

1. Assist in establishing, developing, and maintaining a GMP QC-Microbiology Lab.
2. Support QC-Microbiology testing and develop related procedures and methods.
3. Participate in EMPQ, cleanroom validation, and related activities/documents.
4. Ensure compliance with cGMP standards during QC testing activities such as Environmental Monitoring, Water Testing, Gas Testing, Gram Staining, Growth Promotion, Bioburden, and Gowning Qualifications.
5. Support continuous improvement initiatives within the QC department.
6. Perform additional duties as needed, with up to 15% travel for project support or business development.

Qualifications

1. Master's degree with 1 year or Bachelor's degree with 3 years of relevant experience in Microbiology, Molecular Biology, Biochemistry, or related fields. Experience in gene and cell therapy products is a plus.
2. Experience with EMPQ, cleanroom validation, and lab optimization.
3. Proficiency in GMP documentation, including authoring and reviewing procedures, test methods, and reports.
4. Experience with Laboratory Information Management Systems (LIMS) or similar software.
5. Training experience is advantageous.
6. Strong problem-solving skills and ability to work independently and in teams.
7. Excellent interpersonal, verbal, and written communication skills.

GenScript USA Inc./ProBio Inc. is an equal opportunity employer committed to diversity and inclusion. We maintain a drug-free workplace.