Process Engineer

Location
Durham, NC, United States
Posted
Jul 08, 2019
Ref
984884
Hotbed
Bio NC
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 CAR T and TCR T cells by executing experiments, modeling the process, and interpreting results for further experiments. This person will collaborate across functional areas to ensure project advancement, rapid execution, and communication of challenges and opportunities. The Process Engineer will play a key role in the cell therapy product life cycle, from development and characterization to commercialization and licensure.

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
  • Lead internal program originating from Discovery and support entire program life cycle
  • Design and execute small-scale exploratory studies and full-scale process demonstration runs
  • Participate in document (SOP, Batch Record, data reports) preparation and review; write and update process associated 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
  • Support manufacturing production runs by assessing risk, establishing preventative measures, investigating and troubleshooting equipment and process issues
  • Participate in technology transfer activities internally and externally to CMOs
  • Assist in general operation and maintenance of the PD-Manufacturing lab as needed

Qualifications

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

Education/Experience:
  • Ph.D. in Cell Biology, Chemical, Biological Engineering or relevant degree with 0-6 months of biopharma industry experience or equivalent (or) MS in Cell Biology, Chemical, Biological Engineering or relevant degree with 3+ years of biopharma industry experience or equivalent (or) BS in Cell Biology, Chemical, Biological Engineering or relevant with 5+ years of biopharma industry experience or equivalent
  • Cell culture or aseptic processing experience is required, preferably with experience in process translation and scale-up from manual cell culture methods to automated closed platforms
  • Basic understanding of the Design of Experiment (DOE) methodology is required, preferably with early or late stage Process Development (Process Characterization/Validation) experience
  • Understanding of Quality by Design (QBD) concepts is desired; familiarity with ICH/FDA or PDA guidelines is a plus
  • Cell therapy manufacturing or process development experience is preferred
  • 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 fast-paced, 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
  • Basic knowledge of Microsoft Office software suite, statistical tools package (JMP, Minitab, or equivalent)

Work Environment

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

Physical Demands

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

Travel Requirements
  • This position may require travel (10-15%)

Precision BioSciences mission and vision is to translate the worlds most powerful genome editing technology into greatly needed products throughout the life sciences, by being the conduit through which the greatest genome engineering challenges are solved. Precisions wholly proprietary ARCUS genome editing platform enables the production of highly specific nucleases that can insert, remove, and modify DNA at essentially any location in a complex genome. Through our ARCUS platform, we are developing genome editing-based products to address critical needs in oncology, genetic disease, agriculture, and beyond. For additional information, please visit www.precisionbiosciences.com

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.