The Senior Process Engineer/Process Engineer will be a key member of the CMC team and will work within CMC Technical Operations to develop and implement operational excellence in the manufacturing and controls of our Cell and Gene Therapy products during clinical development phases and in preparation for commercial launch.
The Senior Process Engineer/ Process Engineer will work closely with Process Development, Manufacturing, Quality Control and Regulatory Affairs to define and implement the manufacturing strategy for Precision’s gene therapy pipeline. The individual will have the responsibility and accountability for technology transfer and technical oversight of manufacturing units (CMOs and in-house manufacturing). The Senior Process Engineer/ Process Engineer will also be involved in the definition and execution of process validation activities needed in the preparation of applications for licensure. The Senior Process Engineer/ Process Engineer will also provide input to Precision’s Development Team, contributing to continuous process optimization and characterization throughout the entire product development lifecycle.
The ideal candidate will have experience in process development and manufacture of gene therapy products and/or biologics. They will have a proven track record of successful technology transfers and GMP manufacturing of clinical trial material, in addition to close interaction with Quality Assurance, Quality Control, and Regulatory Affairs. The ideal candidate will have strong interpersonal skills and a high level of independence to carry out their responsibilities with minimal supervision.
**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.
- Support CMOs and in-house manufacture of AAV drug product and drug substance intermediate. Provide technical support to external manufacture of plasmids and mRNA
- Support Process Technology Transfer activities (incl. personnel training) and provide technical oversight of manufacturing unit(s) during manufacturing campaigns
- Work collaboratively with Manufacturing, Quality Assurance and Quality Control to ensure timely manufacturing and release of GMP compliant drug product
- Support technical trouble shooting, investigations, root cause analysis, CAPAs, impact assessment and change controls
- Author and review manufacturing documentation (e.g. Protocols, Process Description, Batch Records, SOPs, Change Controls, and manufacturing campaign summary reports)
- Contribute to the writing and review of IND/IMPD filings
- Contribute to the execution of process validation
- Provide engineering input and support to Process Development teams
- Conduct risk assessment (FMEA, critical Process Parameter identification) and COG analysis to revise and optimize process control strategy and identify key areas of process optimization
- Uphold the core values of Precision Biosciences as our representative working closely with external partners
- Perform other related duties as assigned
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
- MS or PhD in Engineering or Biochemical Sciences and 4+ years of biopharma process development or manufacturing experience of complex biologics, or equivalent combination of education and experience; title to commensurate with experience
- Excellent working knowledge of GMP and GLP requirements
- Strong understanding of Quality Systems and demonstrated proficiency in application of QA principles, concepts, industry practices, and standards
- Experience with TFF, Chromatography, Dead-end Filtration, or Cell Culture
- Good conceptual, strategic, analytical, problem solving, and organizational skills
- Autonomous, take-charge, proven team player with a strong results orientation, positive “can do”
attitude, and a sense of urgency to get things done
- High emotional intelligence, sound temperament and professional attitude
- Excellent communication skills, both verbal and written, and the ability to interface effectively with all level of the organization; strong communication skills with outside contract organizations is required.
- Fully versed with Microsoft Office software suite, DOE software such as JMP or Minitab, project management software such as Microsoft Project or Smartsheet, and process simulation software such as Aspen Batch or SuperPro
- Personal alignment with Precision’s values, mission and vision
- This position will require travel (up to 20%), both domestic and international. Travel can include conferences, equipment vendors, or onsite support of outsourced manufacturing.
· This is a primarily office-based position associated with the main headquarters and MCAT facility 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.