The Process Engineer works within the Cell Therapy Development team and will participate in manufacturing technology development efforts both internally and in collaboration with industry partners, delivering best-in-class manufacturing methods for allogeneic T-cell therapies. The position will assist in process development efforts for CARs and TCRs by providing process simulation, cost modeling, and execution of experiments. This person will collaborate across all functional areas to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Process Engineer will play a key role in the product life cycle, including development/characterization, commercialization, licensure, and evolution of cell therapy products.
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 manufacturing processes and process improvements for allogeneic CAR-T cells and critical materials such as viral vectors and mRNA.
- Lead small-scale exploratory studies and full-scale process demonstration runs.
- Participate in document (SOP, Batch Record, data reports) preparation and review. Create, oversee, write, and update validation plans, protocols, and reports for small and full-scale studies
- Conceptualize next-generation cell therapy manufacturing strategies and methods including co-development of new tools and technologies with industrial partners
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
- Participate in technology transfer activities to CMO’s
- Assist in general operation and maintenance of the PD-Manufacturing lab
- Equipment maintenance. Manage consumables & reagents inventory.
- Other work as needed.
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
- MS in Cell Biology, Chemical or Biological Engineering with 2+ years of biopharma industry experience or equivalent.
- BS in Cell Biology, Chemical or Biological Engineering with 5+ years of biopharma industry experience or equivalent
- Proven experience in the Design of Experiment (DOE) methodology. Proven experience in developing novel technologies to apply to bioprocesses.
- Preference is given to candidates with commercial cell therapy or viral vector manufacturing technology transfer and technical support experience.
- Cell culture or aseptic processing experience is required. Preference is given to candidates with experience in process translation and scale-up from manual cell culture methods to automated platforms featuring single-use disposables.
- Practical experience in a cGMP environment is preferred; process validation experience is a plus.
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills.
- 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, establish facts, and draw valid conclusions.
- Demonstrated ability to work in the fast-paced environment is desired.
- Should have knowledge of Microsoft Office software suite, statistical tools package (JMP, Minitab or equivalent)
The work environment characteristics described here are representative of those an employee could potentially encounter while performing the essential functions of this job.
- While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; biohazardous, toxic, or caustic chemicals and risk of electrical shock.
- The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- The employee must occasionally lift and/or move up to 50 pounds.
- Specific vision abilities required by this job include close vision, color vision, peripheral vision and ability to adjust focus.
- While performing the duties of this job, the employee is frequently required to stand walk; sit; use hands to handle or feel and talk or hear.
- The employee is occasionally required to reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
- This position may require travel (5-10%)
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.