Process Development Engineer II Or III

Summary

The Process Engineer II/III works within the Cell Therapy Process Development team and will manage process development efforts, delivering best-in-class manufacturing methods for allogeneic T cell therapies. The position will directly contribute the clinical progression of candidate CAR T cell therapies by designing and managing the execution of process development experiments across a variety of process scales and will represent the CMC function on cross-functional project teams. The Process Engineer II/III will collaborate internally across functional areas as well as externally with industry partners to ensure project advancement, rapid and best-in-class execution, and effective communication of challenges and opportunities. The Process Engineer II/III will play a key role in product life cycle, including IND-enabling development, characterization, commercialization, licensure, and evolution of cell therapy products. The Process Engineer II/III will also be a key contributor to define and drive process development strategy, and to build and develop a high performing technical team.

**Please note, Precision BioSciences mandates COVID-19 vaccination of all employees. Accommodations may be made in accordance with applicable law.

Essential Duties and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

• Serve as subject matter expert in cell therapy process design and characterization, leading technical projects to improve product quality, yield, and consistency
• Design and manage the execution of optimization, robustness, and characterization studies using appropriate engineering approaches and statistical methods
• Lead and manage one or more Scientist(s), Engineer(s), and/or Associate(s) developing and improving the allogeneic CAR / TCR T manufacturing platform
• Clearly communicate and drive completion of CTPD team goals; aligning priorities with the CTPD Team Leader
• Manage and mentor junior team members; provide regular feedback and coaching for individual development

• Work closely with Technical Operations to support technology transfer activities to CMOs and internal manufacturing sites
• Ensure successful cGMP manufacturing runs by supporting the Technical Operations and Manufacturing groups in assessing risk, developing preventative measures, and troubleshooting process issues
• Work with Analytical Development to develop fit-for-purpose assays and methods throughout the product lifecycle, bringing assays into CTPD as needed
• Organize and analyze data from diverse bioanalytical data sources for presentation at group, department, and program meetings
• Perform and maintain technical risk assessments to prioritize process parameters for characterization studies
• Work with cross-functional teams to systematically develop process characterization plans
• Represent the CMC function on cross-functional program teams (as needed)
• Write and review technical and regulatory documents including ELN entries, batch records, work instructions, SOPs, technical reports, IND sections, and BLA sections
• Pursue and manage the evaluation of next-generation cell therapy manufacturing strategies and technologies
• Provide engineering, scale-up, and operational expertise to interfacing functional areas

Qualifications
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required:

• Degree in Chemical Engineering, Biological Engineering or relevant biological sciences discipline
• Engineer II: MS/PhD with 2+ years biopharma process development and CMC experience or equivalent, BS with 5+ years
• Engineer III: MS/PhD with 5+ years biopharma process development and CMC experience or equivalent, BS with 8+ years

• Proven technical expertise in bioprocess design and development including mammalian cell culture and T cell biology
• Robust understanding of cGMP regulations and experience developing compliant cell therapy manufacturing processes
• Ability to think critically under pressure, troubleshoot and solve engineering problems
• Excellent interpersonal, written, and verbal communication skills
• Ability to manage and develop junior team members, driving productivity and team cohesion
• Working knowledge of analytical methods used for T cell product characterization
• Demonstrated ability to present complex technical topics to a wide range of audiences with varying technical depth
• Ability to define problems, collect and analyze data, and draw valid and appropriate conclusions
• Mastery of Microsoft Office software suite, and proficiency with statistical tools package (JMP preferred)

Preferred:

• Experience in late-stage biologics or cell therapy process development activities and BLA preparation
• Mastery of Design of Experiment (DoE) methodology, mathematical modeling, and common biostatistical methods

Travel Requirements

• Minimal travel will be expected in this position.

Location

• This is a primarily office-based position associated with the main headquarters in Durham, NC.

Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. This isn’t just a statement supporting the products that we’re developing – it’s a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com

Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Job Type: Full-time