Job: Process Development Engineer - Downstream, Precision BioSciences, Durham, NC
Process Development Engineer - Downstream
Durham, NC 27701 United States
The Process Development Engineer will work within the AAV Process Development Team and will participate in the development of downstream purification processes, delivering best-in-class purification process design for viral vector drug substances and drug products, for the development of in vivo and ex vivo gene therapies. The incumbent will drive the downstream process development for the manufacture of AAV-based cell and gene therapies. The ideal candidate for this position is an experienced Scientist/Engineer with a strong background in AAV purification process development technologies and an excellent track record in gene therapy downstream process development. The candidate should have experience with small scale DoE screening, process scale-up, process optimization, and tech transfer for GMP manufacturing. This person will collaborate across all functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Process Engineer will apply QbD principals to all aspects of operations including process development/characterization, technology transfer, PPQ/PV, and contributing to CMC submissions.
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 robust, scalable purification processes for AAV gene therapy vectors
Evaluate novel and emerging technologies to advance vector purification strategy
Provide scientific expertise and guidance in clinical AAV production, development and innovation for all commonly used downstream purification technologies (chromatography, depth/dead-end filtration, nanofiltration, and UF/DF)
Scaling-up of downstream processes to ensure successful transfer to cGMP manufacturing
Preparing and modifying process development and manufacturing documents (PDPRs, SOPs, process development and investigation reports, etc.), supporting regulatory submissions when required.
Support ancillary upstream operations and analytical development and testing as needed
Participate in project related teams as a subject matter expert
Conduct technical investigations of production runs, determine root cause, and provide solutions to various issues in downstream process development
Demonstrate leadership and foster a team environment
Work independently in a collaborative, scientifically stimulating, fast-pace environment
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
MS in Chemical Engineering or Bioengineering with 2+ years of industrial bioprocess development experience, or equivalent
BS in Chemical Engineering or Bioengineering with 5+ years of industrial bioprocess development experience, or equivalent
Proven experience in developing novel technologies to apply to bioprocesses
Proven experience in mathematical modeling of bioprocesses, process simulation and/or cost of goods modeling
Proven experience in Design of Experiment (DOE) methodology
Preference given to candidates with clinical and/or commercial cell therapy or viral vector manufacturing technology experience
Preference given to candidates with experience in process translation and scale-up from manual purification methods to automated platforms featuring single-use systems
Pharmaceutical products GMP manufacturing or process development experience is required
Previous experience with gene therapies, specifically AAV, is a plus
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, and process development
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
Should have knowledge of Microsoft Office software suite, and statistical design of experiment software such as JMP or Minitab
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; 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 25 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 (10%)
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