GENERAL DESCRIPTION
Andelyn Biosciences is an industry-leading cGMP production facility dedicated to advancing the field of gene therapy. Our mission is to use our knowledge, resources, technology, and experience in the field of translational and regulatory science, to develop new, safe, and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope on the minds of every patient and their families. Andelyn is primarily a full-service manufacturer of Adeno Associated Virus (AAV). We work with over 100 clients each year to manufacture AAV at development, toxicology, clinical and commercial quality.
The GMP Quality Control (QC) Supervisor will provide daily control of the GMP QC laboratory. The primary objective is to ensure that all activities within the GMP QC laboratory facility are in compliance with the requisite regulations. Working in close collaboration with the QC Manager, the QC Supervisor will oversee all day-to-day lab operations, including project and timeline management, personnel, and lab facility management. The QC Supervisor will ensure all staff working in the QC laboratory are properly trained and operate in a consistent manner following appropriate regulatory practices, analytical methods, and Standard Operating Procedures (SOPs) for GMP and GLP operations.
PRINCIPAL DUTIES AND RESPONSIBILITIES
1. Works in close collaboration with the QC Manager to cultivate and enact strategic direction of the QC Lab area including determination of schedule and project timelines/capabilities.
2. Oversees the writing and execution of analytical test methods and testing protocols in coordination with QC Manager to ensure proper procedures are in place for QC Lab operations.
3. Directs and reviews, in coordination with QC Manager, the creation and maintenance of Standard Operating Procedures that affect the conduct of operations within the QC laboratory (equipment and process SOPs) and ensures that they are written with proper scope, detail, and format to meet FDA guidelines.
4. Acts as a central point of control for all laboratory data generated from QC laboratory tasks, including in-process, release, and stability testing. Manages and reviews the compilation of all data, ensures its correctness, and report findings to GMP management staff.
5. Supervises / coordinates the proper operation, calibration, validation, cleaning, and maintenance of QC laboratory equipment and systems as specified in methods.
6. Works in coordination with QC Manager and QC Coordinators in management of the QC portion of deviation investigations, OOS results, process change controls, and required process SOP revision and remediation.
7. Responsible for GMP Quality Control technical staff performance, including hiring, providing feedback, annual performance reviews, and termination if necessary.
8. Works in close collaboration with the QC Manager to ensure continuous improvement objectives are identified and met using metrics and other statistical means.
9. Works in close collaboration with the QC Manager to ensure new projects and technologies are sought for incorporation into the QC Lab area.
Reports to: Quality Control Supervisor – Andelyn Biosciences
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED
1. Requires a BS/BA or MS with a scientific background.
2. Minimum of 3-5 years of experience with biochemical or analytical Quality Control background Experience with the management, direction, and mentoring of technical staff in a laboratory environment.
3. Experience in relevant skills and tasks such as Aseptic Manipulations, Mammalian Tissue Culture, PCR, ELISA, Electrophoresis, Microbiology, etc. preferred.
4. Experience in laboratory operations under GMP or GLP regulations preferred.
MINIMUM PHYSICAL REQUIREMENTS
- Typing on a computer keyboard Constantly (0-33%)
- Standing/walking Occasionally (30-67%)
- Lift weight at 20-30lbs (0-33%)
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision. EOE M/F/Disability/Vet