Quality Control Laboratory Manager

Rocket PharmaceuticalsCranbury, NJ
18d$122,000 - $144,000Onsite

About The Position

This Quality Control (QC) Laboratory Manager role is a scientific based position that involves reviewing and analyzing test results as well as overseeing daily lab operations. You will be a key team member responsible for keeping QC operations running in an efficient and productive state. This role interacts with the lab technicians, management, EHS, Facilities, and QA to ensure strict adherence to procedures with a continuous improvement mindset. The ideal candidate will be extremely organized, have a strong analytical operations background, and have a strong passion and curiosity for science and gene therapy.

Requirements

  • M.S. in Biology, Molecular biology, or Immunology with 4+ years of relevant experience or BS in Biology, Molecular Biology, or Immunology with 6+ years of relevant experience or equivalent experience in the biotechnology industry.
  • Ability to be onsite 5 days per week
  • Deep understanding and experience with working in a GMP environment
  • Experience with ddPCR, ELISA, Flow-cytometry, UPLC and/or cell-based assays
  • Ability to work independently and make decisions
  • Leadership experience and project management skills to support a multi-project environment in small biotech.

Responsibilities

  • Managing Lab Technician(s) overseeing sample management (receipt, storage, distribution, and disposal) and stocking of lab consumables and reagents
  • Scheduling assays through Electronic Scheduling System for QC and preparing all necessary materials and controlled worksheets and protocols/methods for the scientists to execute the assays
  • Supporting Management by performing peer reviews of testing data
  • Supporting Method Performance tracking and trending through data entry, verification, and record archival
  • Establishing and maintaining training curriculum for the lab scientists and supporting scheduling for cross-training of analysts
  • Maintaining control and inventory of critical reagents, Reference Standards, Retains/Reserves, etc.
  • Operations tracking including Assay Results, Invalid Assays, and Equipment cleaning, maintenance, and calibration
  • Tracking on time closure of QC Quality records including Deviations, Invalid Assays, OOS and CAPAs and reporting of Metrics upwards to QC/QA management
  • Support revision of SOPs and forms to improve workflows in QC
  • Overseeing Housekeeping activities of lab areas
  • Verifying Logbooks are reviewed on time
  • Tracking Lab Notebooks lifecycle
  • Working with EHS to improve Safety Culture in QC

Benefits

  • Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.
  • Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year’s, and a variety of wellness resources and employee support programs.
  • Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).
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