Associate Director, Laboratory Operations

Location
Durham, NC, United States
Posted
Jul 23, 2021
Ref
1686982
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
The Associate Director, Laboratory Operations oversees and sets priorities for the Laboratory Operations team to ensure each of the supported laboratories are reliable, operating efficiently, safely and within approved GLP and GMP guidelines. This position will report to the Director of Facilities and Laboratory Operations. This position will:
  • Manage the Laboratory Operations team to ensure maintenance and calibration of laboratory equipment are scheduled and performed
  • Oversee laboratory related projects, coordinate purchasing of new equipment and develop vendor contracts
  • Build and oversee the maintenance, calibration, and support of Laboratory Automation for the sites R&D and clinical laboratories
  • Develop and provide leadership to the Laboratory Operations team to achieve departmental objectives and goals


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.

Laboratory Management:
  • Work with the Director of Facilities and Lab Ops to establish a laboratory organization plan and delegate responsibilities, authorities, and accountabilities to appropriate team members
  • Collaborate with the Laboratory Operations team, colleagues, and departmental staff to drive department goals, objectives and prioritize work
  • Develop and oversee the equipment maintenance, instrumentation, and calibrations in the laboratories to ensure all equipment is operational and remain compliant
  • Establish and implement laboratory training programs to assess knowledge, skills, and abilities, as well as job performance and competency
  • Responsible for cGMP compliance and inspection of labs; review and approve documentation associated with method validations/qualification/verification, investigations, change controls and technical reports
  • Assure appropriate levels of cGXP compliance, including documentation practices
  • Leverage broad technical knowledge to evaluate new technologies and determine the best course of action
  • Assist with the research of new equipment, when necessary, from evaluation of need, to laboratory and facility logistics, to procurement and installation; serve as the point of contact with the equipment vendors
  • Contribute to lab automation process development efforts from conception, implementation, validation and continue support and maintenance for the program
  • Oversee and perform in-system configurations, electronic laboratory notebook (ELN) / WorkBook methods and/or system reports and be able to review and approve system qualifications
  • Configure and maintain LIMS computer system
  • Oversee Master Data of new products and new test methods, including Laboratory Execution System (LES) templates within the LIMS. Update Master Data as needed to ensure continued compliance and alignment with QC policies, product specifications, testing and stability protocols, and analytical methodology
  • Oversee and guide the Laboratory operations team on continuous improvements strategies including implementation of latest technologies
  • Must be willing to respond to off-hour issues with laboratory equipment and instrumentation


Purchasing:
  • Closely work with Purchasing Agent / Buyer to order all lab consumables including negotiating best pricing available through multiple vendors


Laboratory Safety:
  • Participate on the Safety Committee; Develop, manage, and train staff on safety best practices
  • Manage all MSDS documentation for Laboratory Operations


Qualifications

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

Required:
  • Bachelor's degree (B. S.) and 8+ years related experience and/or training; or equivalent combination of education and experience.
  • Strong knowledge and experience with troubleshooting laboratory equipment issues with the ability to train laboratory operations staff
  • Experience using a Computerized Maintenance Management System (CMMS) for scheduling, calibrating and maintaining laboratory equipment
  • Experience managing Laboratory Operations and instrumentation / metrology department with 5+ professionals for 2+ years.
  • Experience working in a pharma GMP lab
  • Experience implementing, overseeing, and managing a LIMS system
  • Personal alignment with Precisions values, mission and vision.


Preferred:
  • Aseptic experience
  • Experience using programs such as Procal, Vaisala EMS, Structureware BAS, Monday.com, Microsoft Office Suite


Travel Requirements
  • This position requires little to no 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.