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Cell Therapy Manufacturing Specialist
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Job Title: Manufacturing Biotechnologist
Job Description">We are seeking an experienced and skilled manufacturing biotechnologist to join our team. As a key member of our operations department, you will be responsible for supporting the successful technology transfer, manufacturing execution, and commercial readiness of cell and gene therapy products in a cGMP environment.
">The ideal candidate will have a strong background in biotechnology, with experience in upstream and downstream manufacturing processes. You should also have excellent knowledge of cGMP practices and global regulatory requirements.
">In this role, you will collaborate with internal/external stakeholders, including QA, QC, MSAT, and commercial teams. You will serve as a Manufacturing Subject Matter Expert (SME) during audits, inspections, and due diligence. You will involve in technology transfers (internal and external) and commissioning, qualification (C&Q) activities.
">You will also support in cell culture, purification, and fill-finish operations in a single-use, aseptic, cGMP facility. You will ensure accurate and timely data entry in digital records, maintaining compliance with Good Documentation Practices (GDP).
">Additionally, you will author, review, and manage cGMP documentation: SOPs, batch records, risk assessments, protocols, etc. You will support with manufacturing change control, deviation investigations and implement CAPAs.
">Requirements:
">- ">
- Minimum Bachelor's Degree in Biotechnology related disciplines or relevant discipline.">
- Minimum of 2-4 years in cGMP Biologics or cell and gene therapy manufacturing with relevant industry knowledge, hands on equipment experience and technical expertise.">
- Strong knowledge of cGMP practices and global regulatory requirements such as USFDA GMP, EU GMP, HSA GMP and PIC/S GMP.">
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).">
- Able to work independently and task oriented in a dynamic environment.">
- Strong team player with a strong set of interpersonal skills.">
- Excellent written and verbal communication skills.">
- Experience in working in cell and gene therapy manufacturing is an added advantage.">
Key qualifications include a minimum of a Bachelor's Degree in Biotechnology related disciplines or relevant discipline, and a minimum of 2-4 years of experience in cGMP Biologics or cell and gene therapy manufacturing. The ideal candidate will have a strong background in biotechnology, with experience in upstream and downstream manufacturing processes.
">Additional skills and qualifications include:
">- ">
- Strong knowledge of cGMP practices and global regulatory requirements such as USFDA GMP, EU GMP, HSA GMP and PIC/S GMP.">
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).">
- Able to work independently and task oriented in a dynamic environment.">
- Strong team player with a strong set of interpersonal skills.">
- Excellent written and verbal communication skills.">
- Experience in working in cell and gene therapy manufacturing is an added advantage.">
This role offers a unique opportunity to join a dynamic and growing company that is at the forefront of cell and gene therapy manufacturing. The successful candidate will have the opportunity to work with a talented team of professionals who share a passion for innovation and excellence.
">Our benefits package includes a competitive salary and benefits, professional development opportunities, and a collaborative and supportive work environment.
">Others">Interested candidates should submit their application, including a cover letter and CV, to apply for this exciting opportunity.
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