Analytical Quality Control, Manager

Job Locations US-NJ-Florham Park
ID
2020-1246
Category
Quality
Type
Regular Full-Time

Overview

Celularity is a next-generation biotechnology company creating off-the-shelf allogeneic cellular treatments for cancer, infectious diseases, and degenerative diseases.  Join our expanding quality team on our mission to lead the next evolution in cellular medicine at our state-of-the-art facility in Florham Park, NJ.

 

As Analytical Quality Control Manager, you will enable the rapid advancement of cellular therapy products from clinical stage through commercialization, including cell and tissue-based products. In addition to leadership and management, you will drive the optimization, implementation, execution, troubleshooting and oversight of analytical methods for manufactured cell therapy products during in-process and release testing.  Responsibilities include overseeing team of scientists in assay execution, troubleshooting, assay transfer, qualification, validation and implementation of clinical ready cell-based and functional methods for all cell therapy products. Assays to include potency, identity, purity, and any other release testing required to confirm routine manufacturing. 

Responsibilities

  • Oversee analytical and functional quality aspects within Quality Control in support of the cell therapy products and platforms. Responsible for the establishment, oversight, and execution of analytical activities for GXP manufactured cell or tissue-based products.  This includes all products under IND in various phase clinical trials. Hands-on testing and data handling in addition to leadership and supervisory activities required.
  • Responsible for the direct training of scientists and technologists to complete assay execution, troubleshooting and routine testing. Work with Management to develop the skills and understanding of various technical processes, analytical testing, GMP/GTP regulations and leadership skills of the Quality Control team.  Provide guidance and mentorship to staff, with accountability for the quality of their work.
  • Work collaboratively with Process Development in the development and technical process transfer of multiple assays and methods from pre-clinical through commercialization. Draft, execute, review and summarize protocols to support assay qualification/validations.  Author and improve Analytical QC Standard Operating Procedures, procedures, methods, technical reports, training matrices, process descriptions and final reports. 
  • Evaluate and identify (real-time) trends within the analytical data. Communicate findings internally to teams, stakeholders, Quality, and Technical Operations management as well as any external laboratories or 3rd party suppliers/labs. Drive towards resolution.
  • Coordinate with Materials Management, Manufacturing, Supplier Management, and 3rd party suppliers/labs regarding sampling, inspection, identification and testing of materials, in-process and final product to ensure quality control prior to QA review and release. Manage all material and product retains.
  • Work with other functional leads (primarily Tech Ops and Process Development) to improve operational efficiency and flexibility, including applying state-of-the-art cellular analytical techniques and methods. Operation of the Analytical Quality Control team and activities must be in support of Manufacturing teams, products and processes. These include but not limited to in-process verifications, line clearances, product and raw materials testing and verifications.
  • Oversight of raw material testing and stability programs. Responsible for establishing and/or adhering to program(s) using in-house and/or external support. Routinely provide data and trends to support IND filings, amendments, etc.
  • Maintain Analytical Quality Control standards applicable to company’s GXP manufactured cell therapy products, including GMP and GTP. Ensure regulatory and quality compliance is maintained.  Serve as an analytical SME and participate in internal/external audits and inspections as required.
  • Control, review, verify and manage all Analytical QC data generated both manually and automated. Participate in implementation of Laboratory Information Management System (LMS/LIMS). Generate, review and verify Certificates of Analysis documenting product testing results and analysis according to product specifications and requirements prior to QA approval.

Qualifications

Required

  • Minimum B.S. in Chemistry, Biology, Bioengineering or related scientific discipline, MS preferred.
  • 7+ years’ experience with analytical and QC operations in GXP environments, including GMP. At least 2+ of those years working in QC release testing (endotoxin, mycoplasma, sterility, viability, etc.) of cell therapy products Required
  • 3+ years’ experience as a lead/supervisor of a scientific team
  • Strong understanding of federal regulations for Quality Systems (21CFR820), GMP manufacturing (21CFR210 and 211) and USP Compendial methods.

Desired

  • Demonstrated scientific creativity, technical proficiency and knowledge of scientific concepts
  • Previous industry or academic experience in CAR-T/cellular therapy research and development, including product characterization, method bridging, comparability, control strategy experience, a plus.
  • Strong organizational and time management skills. Ability to work on and/or lead multiple tasks concurrently.
  • Strategic thinker with excellent problem solving and conflict resolution skills.
  • Dynamic individual with the ability to communicate, engage others and lead teams
  • Independent and self-starting. Ability to work with minimal supervision
  • Flexible schedule

 

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