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Process Engineer, CMC Technical Operations

Company: Precision BioSciences
Location: Durham
Posted on: November 10, 2019

Job Description:

The 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 Process Engineer will work closely with Process Development, Manufacturing, Quality Control and Regulatory Affairs to define and implement the manufacturing strategy for Precisions cell therapy pipeline and high quality starting materials. The individual will support technology transfers technical oversight of manufacturing units (CMOs and in-house manufacturing). The Process Engineer will also be involved in the definition and execution of process validation activities needed in the preparation of applications for licensure. The Process Engineer will also provide input to Precisions 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 clinical biologics and clinical cell therapies. 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. 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 mRNA, AAV, and cell therapy drug products (e.g., CAR-T)
  • 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/or 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 with to revise and optimize process control strategy and identify key areas of process optimization
  • Contribute to the writing of the Technical Operation SOPs (e.g. SOPs, protocols, reports) to meet global regulatory expectations, as required
  • Uphold the core values of Precision BioSciences as our representative working closely with external partners
  • Perform other related duties as assigned Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Education/Experience:
    • BS or MS in Engineering or Biochemical Sciences
    • 2+ years of biopharma process development or manufacturing experience of complex biologics
    • 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
    • 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 Precisions values, mission and vision Travel Requirements
      • This position will require travel (up to 20%), both domestic and international. 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.

Keywords: Precision BioSciences, Durham , Process Engineer, CMC Technical Operations, IT / Software / Systems , Durham, North Carolina

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