The Associate Process Engineer works within the Cell Therapy Development team and will participate in process development efforts, delivering best-in-class manufacturing methods for allogeneic T cell therapies. The position will assist in the clinical progression of candidate CAR and TCR T cell therapies by designing and executing process development experiments across a variety of process scales. The Associate Process Engineer 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.
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.
Develop and improve manufacturing processes for allogeneic CAR and TCR T cells and critical materials such as viral vectors and mRNA
Assist in the design and lead the execution of small-scale unit operation optimization and robustness studies using design of experiments (DoE) methodology
Organize and analyze data from diverse bioanalytical data sources for presentation at group and department meetings
Plan and assist in the execution of full-scale process demonstration runs
Write and review technical and regulatory documents including ELN entries, batch records, work instructions, SOPs, technical reports, and INDs
Pursue and evaluate next-generation cell therapy manufacturing strategies and technologies
Participate in internal and external technology transfer activities including new operator training and cGMP documentation development and review
Ensure successful cGMP manufacturing runs by supporting the Technical Operations and Manufacturing groups in assessing risk, developing preventative measures, and troubleshooting process issues
Provide engineering, scale-up, and operational expertise to interfacing functional areas
Assist in general operation and maintenance of the Process Development lab
Maintain laboratory equipment and manage consumables & reagents inventory
Occasional after-hours and weekend work may be required
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
MS in Chemical Engineering, Biological Engineering or relevant biological sciences discipline with 0-2 years of biopharma industry experience or equivalent (or) BS in Chemical Engineering, Biological Engineering or relevant biological sciences discipline with 2+ years of biopharma industry experience or equivalent
Cell culture and aseptic processing experience are required. Preference is given to candidates with experience culturing primary lymphocytes
Proficiency in common biostatistical methods (hypothesis testing, ANOVA) is required and basic understanding of the Design of Experiment (DOE) methodology is preferred
Ability to think critically under pressure, troubleshoot and solve engineering problems
Excellent interpersonal, verbal and written communication skills
Ability to function efficiently and independently in a changing environment
Ability to read, analyze, and interpret common scientific journals
Ability to define problems, collect and analyze data, and draw valid conclusions
Demonstrated ability to work in the fast-paced environment is desired
Experience with cGMP regulations and manufacturing processes is a plus
Mastery of Microsoft Office software suite, and proficiency with statistical tools package (JMP, Minitab, or equivalent)
This position may require travel (5-10%)
This position is located at the main headquarters located in Durham, NC and is required to physically be and work in the office, in order to be most effective, and at managers discretion.
Precision BioSciences is dedicated to improving life through its proprietary genome editing platform, “ARCUS.” Precision BioSciences leverages ARCUS in the development of its product candidates which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food.
Precision BioSciences provides 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.