Process Development Scientist II, AAV

Location
Durham, NC, United States
Posted
Jan 10, 2021
Ref
1464516
Hotbed
Bio NC
Required Education
Masters Degree/MBA
Position Type
Full time
The Process Development Scientist will work within the AAV Process Development team and will participate in the development of downstream purification 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 candidate will support the process development, process characterization, and tech transfer of said processes for GMP manufacturing. The candidate will assist in the clinical progression of in vivo therapies by designing and executing downstream and formulation development experiments across a variety of process scales. The Process Development Scientist 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.

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 and formulation processes for AAV gene therapy vectors
  • Evaluate novel and emerging technologies to advance vector formulation and purification
  • Provide scientific expertise and guidance in clinical AAV production, development and innovation for all commonly used downstream purification technologies (chromatography, depth filtration, nanofiltration, and UF/DF/TFF)
  • Design and lead the execution of small-scale unit operation optimization and robustness studies using Design of Experiments (DoE) methodology
  • Organize and analyze data from diverse bioanalytical data sources for presentation at group and department meetings
  • Plan and assist in the execution of full-scale process demonstration runs
  • Write and review technical and regulatory documents including ELN entries, batch records, work instructions, SOPs, technical reports, and INDs
  • Participate in internal technology transfer activities including new operator training and cGMP documentation development and review
  • Participate in cross-functional project teams as a representative for the AAV process development team
  • 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 Biology, Chemistry, Chemical Engineering, Biological Engineering or relevant biological sciences discipline with 3+ years of biopharma industry experience or equivalent (or) BS in Biology, Chemistry, Chemical Engineering, Biological Engineering or relevant biological sciences discipline with 5+ years of biopharma industry experience or equivalent (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

Preferred:
  • Clinical and/or commercial viral vector manufacturing technology experience
  • Previous experience with gene therapies, specifically AAV
  • Experience with cGMP regulations and manufacturing processes
  • Proficiency in common biostatistical methods (hypothesis testing, ANOVA) is required and basic understanding of the Design of Experiment (DOE) methodology
  • Mastery of Microsoft Office software suite, and proficiency with statistical tools package (JMP, Minitab, or equivalent)
  • Ability to think critically under pressure, troubleshoot and solve engineering problems
  • 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, and draw valid conclusions

Travel Requirements
  • This position may require travel (5-10%)

Location
  • This position is located at the main headquarters located in Durham, NC and is required to physically be and work in the office, in order to be most effective, and at managers discretion.


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.