Employment Type: Permanent Position

Job Category: Biomanufacturing

Job Number: 2340014

Roger Trinh Talent Solutions is partnering with a growing Houston-based contract manufacturing company. Our client seeks a Principal Scientist (Associate Director level) to join their process development team. This person reports to the Director of process development.

Responsibilities

• Leads and oversees process development projects assigned by leadership with the goal to improve manufacturing processes for CAR-T, TILs and other T-cell therapies.  
• Assess manufacturing processes supplied by prospective partner companies for suitability for GMP manufacture and identify any gaps.
• Design, plan and oversee execution of the experimental plans to optimize/refine manufacturing process for T-cell therapeutics.
• Manage, coach and develop reports.
• Participate in hands-on project execution as needed, serve as a resource/subject matter expert for the technical team. Assign and manage reports to complete projects and trains junior team members on T-cell therapy processing. Troubleshoot technical issues with the team as they arise in the lab and share best practices and lessons learned. 
• Develop processes in alignment with the latest FDA guidance and regulations applicable to the generation and quality monitoring of T-cell therapy products to ensure rapid translation of developed procedures in the GMP lab. 
• Drive internal tech transfers from process development to manufacturing team. Lead the team to produce a complete draft of the manufacturing batch record aligned with the companies' quality standards at the conclusion of the development campaign and trains manufacturing operators in preparation for the engineering runs.
• Provide technical assessment of various new cell therapy technologies and make recommendations on process decisions for GMP implementation. 
• Coordinate execution of project deliverables to meet timelines. 
• Maintain current knowledge of the T-cell manufacturing field and introduce relevant materials to continuously improve the current processes.  
• Maintain thorough accurate, legible, and organized written and electronic records, including use of electronic lab notebook. 
• Author or review protocols, technical reports and draft manufacturing batch records. Author or review process-related CMC sections of IND applications. Train team members on authorship of said documents and eventually delegates authorship.
• Prepare scientific presentations to report on the status of the work performed in the laboratory and speak in front of a group of scientists and leadership that may include external partners .
• Communicate effectively within the company with members of own team or other departments such as manufacturing, analytical development, quality control, regulatory affairs and project management.  
• Interface with appropriate internal and external key stakeholders, work with other functions / departments to achieve project objectives.
• Other duties as assigned.

Qualifications/Skills

• Ph.D. in a related scientific/engineering field.
• 10+ yrs. experience in PD laboratory operations developing processes on various cell manufacturing platforms and closed systems for the development of T-cell therapy products.   
• Strong knowledge in T-cell biology.  
• 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.  
• Able to operate as an effective tactical, as well as strategic thinker. 
• Able to coach and influence junior level scientists and associates.  
• Flexible to work outside of normal business hours (nights, weekends) as needed.
• Proficient with Microsoft Office Suite or related software.

Working Conditions, Equipment, Physical Demands

The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:

Equipment- Computer, printer, fax, and telephone.

Physical Demands- 

• Frequent sitting, standing, walking
• Carrying packages and moving bins and boxes, lifting up to 10 lbs.

Benefits

Medical, Dental, Vision, Life Insurance, Retirement, and Paid Time Off

Relocation Assistance: Yes