Scientist II, Analytical Development

Location
Durham, NC, United States
Posted
Jul 10, 2021
Ref
1671967
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
The Scientist II, Analytical Development Gene Therapy Analytics will develop physiochemical methods designed at characterizing and/or measuring the critical quality attributes (CQAs) of cell and gene therapy products. They will be responsible for independently designing and executing laboratory experiments, compiling relevant findings into reports, and presenting results to internal and external stakeholders. The successful candidate will be comfortable working in a dynamic, cross-functional, work environment.

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.
  • Development and support of CE methods to for the analysis of proteins, oligonucleotides, and carbohydrates from gene therapy products.
  • Development and support of HPLC/UPLC methods (SEC, IEX, and RP using UV, FLR, and CAD) to measure the CQAs of cell and gene therapy products
  • Testing of in-process, drug substance, and drug product samples using CE and HPLC/UPLC
  • Participating in tech transfer protocols to transfer developed methods and acquired knowledge to the QC team
  • Authoring and reviewing analytical test methods, protocols, and technical reports
  • Engaging with internal and external stakeholders/customers to set strategic goals, generate workplans, and discuss findings


Qualifications

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

Required:
  • PhD in Biochemistry, Analytical Chemistry or a related discipline with 2+ years of industry experience or Masters degree in Biochemistry, Analytical Chemistry or a related discipline with 6+ years of industry experience or BS in Biochemistry, Analytical Chemistry or a related discipline with 11+ years of industry experience or equivalent combination of education and experience
  • Demonstrated ability to develop CE and HPLC/UPLC methods to characterize or measure the CQAs of in-process, drug substance, and drug product samples
  • Thorough understanding of Quality by Design (QbD)
  • Use of excellent oral and written communication skills to present findings to a broader scientific audience and to author technical documents (protocols, reports, and SOPs)
  • Success working in a dynamic, cross-functional environment


Preferred:
  • Experience developing methods for cell and gene therapy products
  • Experience with the following techniques: DLS, DSC, AUC, ITC, large molecule LC-MS, and MALS
  • Experience working in a GMP environment
  • Previous people leadership or mentoring experience


Travel Requirements
  • This position may require up to 10 % travel


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 isnt just a statement supporting the products that were developing its 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.