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Manager, Quality Control

Employer
Precision BioSciences, Inc.
Location
Durham, NC
Start date
Nov 20, 2022

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC
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Job Details

Summary

 

The Manager, Quality Control, within the Quality and Compliance Team will develop, implement and manage the processes for internal Quality Control activities to support clinical and commercial cellular and gene therapy products. This person will lead the Quality Control team while also working hands-on in the Quality Control lab to ensure compliance with FDA and other regulatory agency requirements, as well as customer and internal company quality systems requirements.

 

**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, implement, and maintain phase-appropriate Quality Management System (QMS) for Quality Control through the development, review and approval of documentation including policies, analytical methods and standard operating procedures (SOPs)
  • Partner with CMC, Manufacturing and Quality Assurance to ensure all internal Quality Control operations / methods are fit for purpose and support compliance / business needs
  • Establish operational objectives, policies, procedures and work plans and delegate assignments to subordinates
  • Accountable for department budget which may be broad and have far reaching impact on the business segment
  • Develop, modify and execute company policies that affect immediate operations and may also have company-wide effect
  • Manage method validation and critical reagent qualification based on input from CMC
  • Manage maintenance and metrology of analytical instrumentation
  • Manage raw material, intermediate, drug product and stability testing for internal programs
  • Generate Certificates of Analysis / Testing for internal programs
  • Perform Quality Control testing on the floor along side Analysts, as needed
  • Supervise Analysts in the completion of Quality Control testing
  • Maintain knowledge of current compliance requirements related to testing of cellular and gene therapy products
  • Review and approve testing results from internal and external testing
  • Coach staff to achieve their full potential. Sets goals and assigns tasks
  • Demonstrate leadership in the creation and development of a high performance culture and driving the best science
  • Assist Quality Assurance, Analytical Development and Process Development with other projects and tasks, where applicable

 

Qualifications

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

 

Required:

  • BS or equivalent in life science or related field with 8+ years industry experience in GMP Quality Control for late stage clinical or commercial cellular or gene therapy products, or equivalent combination of education and experience
  • Experience with analytical methods specific to cellular and gene therapy products including (but not limited to) flow cytometry, ELISA, and qPCR
  • Knowledge of FDA regulations and standards, especially those pertaining to the production and testing of biological products
  • Thorough understanding of key areas impacting the drug development process
  • Works on issues where analysis of situations or data requires conceptual thinking and an in-depth knowledge of organizational objectives

 

 

Preferred:

  • Familiarity with HPLC, capillary electrophoresis, and cell-based functional and potency assays

 

Travel Requirements

  • This position requires up to 15% travel.
 

Location

  • This is an office-based position located at the MCAT Manufacturing 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.

 

Company

Precision BioSciences, Inc. (Nasdaq: DTIL) is a clinical stage gene editing company developing in vivo gene editing and ex vivo allogeneic CAR T therapies with its highly precise and versatile ARCUS genome editing platform. ARCUS uses sequence-specific DNA-cutting enzymes, or nucleases designed for gene knock out, as well as highly sophisticated edits for gene insertion and/or gene repair. Precision’s in vivo gene editing pipeline consists of wholly-owned preclinical candidates for primary hyperoxaluria type 1 (PBGENE-PH1), familial hypercholesteremia (PBGENE-PCSK9) and chronic hepatitis B (PBGENE-HBV). It has also partnered with Lilly to develop candidates for Duchenne muscular dystrophy and two other programs targeting the liver and CNS. Precision’s allogeneic CAR T pipeline consists of multiple investigational candidates in early-stage clinical trials, including its first and second generation CD19 targeting candidates PBCAR0191 and PBCAR19B for relapsed and/or refractory (R/R) non-Hodgkin and B-cell lymphoma patients. Precision has also prioritized development of PBCAR269A, its BCMA targeted candidate in combination with a gamma secretase inhibitor for R/R patients with multiple myeloma. Precision BioSciences and its in-house manufacturing facility for AAV, mRNA, and CAR T cells is based in Durham, North Carolina. For more information about Precision BioSciences please visit www.precisionbiosciences.com

Stock Symbol: DTIL

Stock Exchange: NASDAQ

Find Us
Website
Phone
919-314-5512
Location
302 East Pettigrew Street
Durham
North Carolina
27701
US
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