Process Development Engineer

Summary:

Precision BioSciences is currently seeking to fill the role of Process Development Engineer. The Process Development Engineer will be a critical part of the team charged with developing a world-class manufacturing process for making an mRNA-based active pharmaceutical ingredient (API). The candidate will participate in all aspects of process development, including in-vitro transcription, downstream purification and testing of products and intermediates.

Primary responsibilities will include:

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.

• Set up and run transcription reactions at small and large scale
• Develop downstream purification operations appropriate to the scale of the process
• Collaborate with the Analytical team to perform in-process and final product testing
• Perform incoming raw material testing and prepare critical buffers and reagents
• Operate and maintain a variety of production equipment, such as mixing vessels, peristaltic pumps, chromatography columns and lab instrumentation
• Maintain accurate and complete lab records and other documentation
• 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
• Train personnel as needed
• Manage final product, process intermediate and raw material inventories
• Participate in technology transfer to GMP production unit

Education and Experience:

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

• Bachelors or Master's degree in Chemical Engineering, Biotechnology, Biochemistry, Chemistry or related field with a minimum of 3years industry experience in biological process development or manufacturing
• Ability to define problems, collect and analyze data, establish facts and draw valid conclusions
• Understanding of GMP regulations for biologics manufacturing
• Strong wet chemistry lab skills, including preparing buffers, handling glassware, working with chemicals and solvents and operating safely in a dynamic R&D environment
• Good working knowledge of nucleic acid chemistry, including appropriate handling procedures
• Familiarity with AKTA, Agilent Chromatography systems and standard purification techniques (membrane filtration, depth filtration, tangential flow filtration)
• Advanced knowledge of chromatography principles (IEX, SEC, HIC, Affinity)
• Comfortable working with sophisticated manufacturing and analytical equipment, including managing calibration programs
• Experience with standard molecular biology skills, including running Agarose, denaturing PAGE gels, ELISA, UV/Vis testing, qPCR and protein testing
• Experience using GE UNICORN and Agilent CHEMSTATION desired
• Experience with DOE methodology for process improvement
• Preference given to candidates with early and late stage process development experience (process validation and characterization)
• Familiarity with Quality-by-Design (QbD) concepts
• Strong communication skills in English, both written and verbal
• Software skills including Excel, Word, and statistical software; experience using SnapGene a plus
• Familiarity with ICH/FDA/PDA guidelines is a plus
• The ability to work both independently and in a collaborative environment.

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.