Cell Therapy Associate Scientist Jobs in Texas

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

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.

Report lab results and inventories to the manager.

Minimal 3 years of wet lab experience in recombinant protein expression is preferred.

Analytical and problem-solving skills in wet lab environments, effectively troubleshooting and overcoming challenges during experiments.

Proficient English verbal and written communication skills for documenting experiments and preparing reports.

Conduct recombinant protein expression using suspension culture techniques in mammalian cell systems.

Adhere to work schedules, conducting technical benchwork for projects.

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

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:

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