Associate, Cell Therapy Manufacturing (Contract)
By Allogene Therapeutics At , Newark, 94560, Ca $34 - $37 an hour
Timely completion of training assignments to ensure the necessary technical skills and knowledge are applied compliantly during GMP operations
Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements
Update and revise manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements·
Must maintain and apply knowledge regarding donor information, screening and testing, labeling and product acceptability and release criteria
Bachelors or Associates in relevant science or engineering discipline with 0-2 years of experience in cGMP biologics or cell therapy manufacturing
Cell culture processing experience in handling and propagation of human primary cells is strongly preferred
Associate Director Global Regulatory Cmc - Cell Therapy
By Shepherd Regulatory Search At Greater Boston, United States
Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
Minimum of 10 years of pharmaceutical/biotech experience, including five years of Global Regulatory Affairs (CMC) experience.
Experience as a RA CMC product lead.
Experience in Cell or Gene Therapy.
Clinical Cell Therapy Associate - Gmp Laboratory
By MD Anderson Cancer Center At , Houston, 77030, Tx
Perform error free calculations, including, but not limited to infusion cell doses, viabilities, dilutions and cell concentrations.
Performs basic technical cell manipulation and testing procedures on irreplaceable cellular products.
Communicate with physicians/investigators, nurses, donor coordinators, internal and external testing laboratories and/or transplant facilities to ensure timely quality patient care.
Minimum Salary: US Dollar (USD) 36,500
Midpoint Salary: US Dollar (USD) 54,500
Maximum Salary : US Dollar (USD) 73,000
Associate Scientist, Cell Therapy
By Johnson & Johnson At , Spring House, Pa
Communicate program progress and issues to management, to regulatory agencies as necessary, and at national conferences as appropriate
Leverage own experience in cell therapy process development to guide autologous platform and process development efforts
Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required
Exposure to and knowledge of GMP manufacturing is a plus.
Problem-solving experience in cell therapy industry with an emphasis on pipeline projects is preferred
Primary responsibilities for this role include, but are not limited to:
Cell Therapy Associate Scientist
By Johnson & Johnson At , Spring House, Pa
Self-motivated with excellent organizational and time management skills is required
Experience with iPSC or stem cell culture and differentiation protocols is required
Ability to independently perform lab-based responsibilities with limited guidance is required
A minimum 2 years of stem cell experience is preferred
Experience with flow cytometry is preferred
Experience with gene editing techniques such as CRISPR/Cas systems is preferred
Quality Control Specialist - Cell Therapy
By Vertex Pharmaceuticals At , Boston, 02110, Ma
Assist in the implementation and qualification of new assays
Write, edit and approve deviations and CAPAs as required. Responsible for initiating change controls and completing necessary documentation
May initiate out of specification (OOS) and deviation investigations as needed to address non-conformances in the lab
Assist in tracking and trending of QC data
Responsible for completing, organizing and filing data. Will need to follow up and modify with documents to reflect complete testing
Perform technical reviews of raw data

Are you a scientist looking to make a difference in the field of cell therapy? Join our team and help us develop innovative bioanalytics solutions that will revolutionize the way we treat diseases. We are looking for a creative and motivated individual to join our team and help us create a new era of cell therapy. If you are passionate about making a difference in the world of cell therapy, then this is the job for you!

Overview:

Scientist Bioanalytics Cell Therapy is a specialized role within the field of biotechnology. This position involves the development and implementation of analytical methods to assess the safety and efficacy of cell-based therapies. The Scientist Bioanalytics Cell Therapy is responsible for designing and executing experiments, analyzing data, and interpreting results.

Detailed Job Description:

The Scientist Bioanalytics Cell Therapy is responsible for developing and validating analytical methods to assess the safety and efficacy of cell-based therapies. This includes designing and executing experiments, analyzing data, and interpreting results. The Scientist Bioanalytics Cell Therapy will also be responsible for developing and maintaining laboratory protocols and procedures, as well as providing technical support to other scientists and researchers.

What is Scientist Bioanalytics Cell Therapy Job Skills Required?

• Knowledge of cell biology, biochemistry, and molecular biology
• Ability to design and execute experiments
• Ability to analyze and interpret data
• Knowledge of laboratory protocols and procedures
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to troubleshoot and problem-solve

What is Scientist Bioanalytics Cell Therapy Job Qualifications?

• Bachelor’s degree in a relevant field, such as biology, biochemistry, or molecular biology
• At least two years of experience in a laboratory setting
• Experience with cell culture and cell-based assays
• Experience with analytical methods such as flow cytometry, ELISA, and PCR

What is Scientist Bioanalytics Cell Therapy Job Knowledge?

• Knowledge of cell biology, biochemistry, and molecular biology
• Knowledge of laboratory protocols and procedures
• Knowledge of analytical methods such as flow cytometry, ELISA, and PCR

What is Scientist Bioanalytics Cell Therapy Job Experience?

• At least two years of experience in a laboratory setting
• Experience with cell culture and cell-based assays

What is Scientist Bioanalytics Cell Therapy Job Responsibilities?

• Design and execute experiments to assess the safety and efficacy of cell-based therapies
• Analyze and interpret data
• Develop and maintain laboratory protocols and procedures
• Provide technical support to other scientists and researchers
• Troubleshoot and problem-solve