Microbiology Specialist CAR-T
Microbiology Specialist CAR-T
Posted on :
25-12-2024
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
We are currently seeking an experienced Microbiologist who can assist in establishing our CART manufacturing GMP facility and managing and supervising production and QC microbiology activities. The ideal candidate should have prior experience in producing biologics and cell therapy products in a cleanroom environment under cGMP regulations.
- Set up the overall microbiology operations of site GMP manufacturing operations as well as ensure that the laboratory is performing to its best and in compliance with all regulatory agencies while aiming towards continuous improvement.
- Responsible for preparing lab layout procuring and qualifying lab equipment and validating software to comply with regulatory standards.
- Prepare and execute microbiology method validation protocols (e.g. sterility mycoplasma endotoxin) equipment qualification CSV etc.
- Plan and execute clean room qualification aseptic process simulation qualification clean room maintenance and risk assessments as per corporate QMS/regulatory requirements etc.
- Serve as an Internal subject matter expert and support regulatory audits.
- To develop EMP for cleanroom monitoring and ensure sterile operation compliance.
- Perform laboratory investigations OOS/OOT/OOL and conduct root cause analysis
- Prepare SOPs and documents to comply with regulatory requirements.
- Develop a disinfectant program/maintenance strategy for the clean room.
- Implement safe working conditions and practices in a laboratory.
- To support in preparing CAPEX and OPEX budget of the laboratory and adhere to the budget
Qualifications :
- Masters degree or bachelors degree in biology Microbiology Biotechnology with 6 10 years of industrial experience in regulated markets and Cell and Gene Therapy.
- Experience of environmental monitoring and bacterial endotoxin testing
- Familiarity and understanding of FDA EU and local industrial requirements.
- Evidence of an acquired solid background of technical knowledge and experience plus successful direction of significant projects
- An ability to work independently as well as a member of a team in a dynamic fastpaced environment is essential
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
