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Process Development Engineer I, Cell Therapy

Precision BioSciences
Durham, North Carolina, United States
8 days ago

Description

Summary

The Process Development Engineer I works within the Cell Therapy Process Development team and will manage process development efforts, delivering best-in-class manufacturing methods for allogeneic T cell therapies. The position will directly contribute the clinical progression of candidate CAR and TCR T cell therapies by designing and executing process development experiments across a variety of process scales and representing the CMC function on cross-functional program teams. The Process Development Engineer I will collaborate internally across functional areas as well as externally with industry partners to ensure project advancement, rapid and best-in-class execution, and effective communication of challenges and opportunities. The Process Development Engineer I will play a key role in product life cycle, including IND-enabling development, characterization, commercialization, licensure, and evolution of cell therapy products.

**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.

  • Develop and improve industry-leading allogeneic CAR / TCR T manufacturing platform
  • Design and execute unit operation optimization, robustness, and characterization studies using appropriate engineering approaches and statistical methods
  • Participate in process technology transfer activities to CMOs and internal manufacturing sites
  • Organize and analyze data from diverse bioanalytical data sources for presentation at group, department, and program meetings
  • Plan and lead the execution of full-scale process demonstration runs
  • Perform risk assessments to identify CQAs and prioritize process parameters for characterization studies
  • Perform FMEA assessments to establish risk mitigation and reduction plans
  • Represent the CMC function on cross-functional program teams
  • Write and review technical and regulatory documents including ELN entries, batch records, work instructions, SOPs, technical reports, IND sections, and BLA sections
  • Pursue and evaluate next-generation cell therapy manufacturing strategies and technologies
  • Participate in internal and external technology transfer activities including new operator training and cGMP documentation development and review
  • Ensure successful cGMP manufacturing runs by supporting the Technical Operations and Manufacturing groups in assessing risk, developing preventative measures, and troubleshooting process issues
  • Provide engineering, scale-up, and operational expertise to interfacing functional areas
  • Assist in general operation and maintenance of the Process Development lab
  • Occasional after-hours and weekend work may be required


Requirements

Qualifications

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

Education/Experience:

Required:

  • Degree in Chemical Engineering, Biological Engineering or relevant biological sciences discipline with biopharma industry experience
    • PhD or MS or BS and 5+ years or equivalent combination of education and expeirence
  • Proven capability in mammalian cell culture and aseptic processing
  • Robust understanding of cGMP regulations and experience developing compliant manufacturing processes

Preferred:

  • Proven expertise in the Design of Experiment (DoE) methodology, mathematical modeling, and common biostatistical
  • Experience in late-stage biologics or cell therapy process development activities and BLA preparation
  • Experience culturing primary lymphocytes or other mammalian cell types in bioreactors
  • Ability to think critically under pressure, troubleshoot and solve engineering problems
  • Excellent interpersonal, written, and verbal communication skills
  • Ability to define problems, collect and analyze data, and draw valid conclusions
  • Demonstrated ability to work in the fast-paced environment is desired
  • Mastery of Microsoft Office software suite, and proficiency with statistical tools package (JMP, Minitab, or equivalent)

Travel Requirements

  • This position will require travel (up to 20%)

Location

· This is an office-based position located at the main headquarters in downtown 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.

Job Information

  • Job ID: 63682914
  • Location:
    Durham, North Carolina, United States
  • Position Title: Process Development Engineer I, Cell Therapy
  • Company Name For Job: Precision BioSciences
  • Job Function: Process Development
  • Job Type: Full Time
  • Job Duration: Indefinite
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 0-1 Year
  • Required Travel: 10-25%
Biotechnology
Durham , North Carolina , United States

Precision BioSciences is dedicated to improving life. Our mission is to cure genetic disease, overcome cancer, and feed the planet. We are achieving this with ARCUS, the first therapeutic-grade, naturally-derived genome editing system that uniquely combines the specificity and efficacy required to overcome life’s greatest genetic challenges. Learn more about the pioneers leading the next genetic revolution at: www.precisionbiosciences.com

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