Roger Trinh Talent Solutions is partnering with a growing Houston-based contract manufacturing company. Our client seeks a Scientist II (Manager Level) to join their product development team in collaboration with Roger Trinh Talent Solutions. The Scientist II will be responsible for developing robust processes for formulation, fill and finish, and cryopreservation of chimeric antigen receptor T (CAR T) and Tumor-Infiltrating Lymphocytes (TIL) cell products. The ideal candidate will be an internal expert in cellular cryopreservation and cryobiology and stay current on advancements in the field. Proficiency in Cryobiologist and Cryopreservation experience with cell therapy drug development (working with different reagents) is required.

Key Responsibilities:

• Developing solid processes for the formulation, fill and finish, and cryopreservation of CAR T and TIL cell products.
• Conducting studies on these products' formulation, fill/finish, and cryopreservation.
• Evaluating new cryobiological technologies.
• Implementing process advancements for scaling up and introduction into a GMP manufacturing environment.
• Leading technology transfer activities and training manufacturing staff on new processes and equipment.
• Monitoring process performance during clinical manufacturing via data tracking, trending, and analysis.
• Designing and conducting experiments in the development laboratory to support process changes, generate process robustness data, and resolve manufacturing non-conformances.
• Drafting technical documents, including development reports, process descriptions, risk assessments, SOPs, MBRs, and regulatory filing sections
• Acting as an internal expert, maintaining state-of-the-art cellular cryopreservation and cryobiology knowledge, and performing other duties as assigned.

Requirements:

• A Ph.D. in a related scientific/engineering field is required.
• Strong knowledge and hands-on experience with cell therapy process development and cryopreservation.
• Highly desired experience:
• Formulation science experience with cryoprotectant additives.
• Demonstrated aseptic cell handling skills.
• Experience working in or supporting a cGMP-regulated environment.
• Hands-on experience with standard cell therapy laboratory equipment and technology platforms

• Familiarity with the following is a plus:
• Solid background in cell therapy manufacturing processes.

• Proficient with MS Office (Excel, Outlook, etc.) and statistical software (Prism, JMP).
• Strong scientific understanding of the fundamental principles of cryopreservation and cell therapy.
• Demonstrated ability to collaborate effectively in a multi-disciplinary team.
• Demonstrated strong communication skills, interpersonal skills, and a superior drive for results.
• Excellent written, oral, interpersonal, and presentation skills and the ability to effectively interface with senior management and staff.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.

If you would like to join a dynamic growing team, apply now. Our client has excellent benefits and offers a competitive salary. Please feel free to contact Roger Trinh about this opportunity. roger@rogertrinh.com

About the Company:
Roger Trinh Talent Solutions