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Process Development Engineer I or II, Upstream AAV

Employer
Precision BioSciences, Inc.
Location
Durham, NC
Start date
Aug 13, 2022

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Job Details

Summary

The Process Development Engineer I or II will work within the AAV Process Development Team and will participate in the development of upstream cell culture and transfection processes, delivering best-in-class 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 upstream process development for the manufacture of AAV-based gene therapies. The ideal candidate for this position is an experienced Scientist/Engineer with a strong background in AAV process cell culture development technologies and an excellent track record in gene therapy upstream process development. The candidate will have extensive experience developing stir-tank bioreactor processes for mammalian cell lines. 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 Development Engineer II will apply QbD principals to all aspects of operations including process development/characterization, technology transfer, PPQ/PV, and contributing to CMC submissions.

 

**Please note, Precision BioSciences mandates COVID-19 vaccination of all employees. Accommodations may be made in accordance with applicable law.

 

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.

 

  • Drive upstream process development of AAV production and technical transfer to GMP
  • Implement and/or develop innovative vector production technologies based on QbD strategies
  • Develop protocols for vector production in suspension HEK293 cell line
  • Perform monitoring of cell viability/growth and cell culture metabolites from cultures
  • Provide scientific expertise and guidance in clinical AAV production, development and innovation
  • Development of optimized, characterized, and robust seed train and bioreactor processes
  • Scaling-up of upstream 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
  • Generate AAV research grade materials for Allogeneic CAR-T platform and in vivo gene correction programs  
  • Support ancillary downstream 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 upstream process development 
  • Demonstrate leadership and foster a team environment
  • Work independently in a collaborative, scientifically stimulating, fast-pace environment

 

Qualifications

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

 

Education/Experience:

 

Required:

  • MS in Chemical Engineering or Bioengineering with 2+ years of industrial bioprocess development experience, or BS in Chemical Engineering or Bioengineering with 5+ years of industrial bioprocess, or equivalent combination of education and experience
  • 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
  • Pharmaceutical products GMP manufacturing or process development experience
  • 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
  • Knowledge of Microsoft Office software suite, and statistical design of experiment software such as JMP or Minitab

 

Preferred:

  • Clinical and/or commercial cell therapy or viral vector manufacturing technology experience
  • Experience in process translation and scale-up from manual purification methods to automated platforms featuring single-use systems
  • Previous experience with gene therapies, specifically AAV

 

Travel Requirements

 

  • This position may require travel (10%).

 

Location

· This is a primarily office-based position associated with the main headquarters in Durham, NC.

 

Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. This isn’t just a statement supporting the products that we’re developing – it’s a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs.  For additional information, please visit www. precisionbiosciences.com

 

Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide 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.

Company

Precision BioSciences, Inc. (Nasdaq: DTIL) is a clinical stage gene editing company developing in vivo gene editing and ex vivo allogeneic CAR T therapies with its highly precise and versatile ARCUS genome editing platform. ARCUS uses sequence-specific DNA-cutting enzymes, or nucleases designed for gene knock out, as well as highly sophisticated edits for gene insertion and/or gene repair. Precision’s in vivo gene editing pipeline consists of wholly-owned preclinical candidates for primary hyperoxaluria type 1 (PBGENE-PH1), familial hypercholesteremia (PBGENE-PCSK9) and chronic hepatitis B (PBGENE-HBV). It has also partnered with Lilly to develop candidates for Duchenne muscular dystrophy and two other programs targeting the liver and CNS. Precision’s allogeneic CAR T pipeline consists of multiple investigational candidates in early-stage clinical trials, including its first and second generation CD19 targeting candidates PBCAR0191 and PBCAR19B for relapsed and/or refractory (R/R) non-Hodgkin and B-cell lymphoma patients. Precision has also prioritized development of PBCAR269A, its BCMA targeted candidate in combination with a gamma secretase inhibitor for R/R patients with multiple myeloma. Precision BioSciences and its in-house manufacturing facility for AAV, mRNA, and CAR T cells is based in Durham, North Carolina. For more information about Precision BioSciences please visit www.precisionbiosciences.com

Stock Symbol: DTIL

Stock Exchange: NASDAQ

Find Us
Website
Phone
919-314-5512
Location
302 East Pettigrew Street
Durham
North Carolina
27701
United States
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