Analytical Quality Control, Director

Job Locations US-NJ-Florham Park
ID
2020-1245
Category
Quality Control
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 Director, 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 be responsible for all material and product testing activities and staff to ensure quality control including the optimization, implementation, execution, troubleshooting and oversight of analytical techniques/methods for manufactured cell therapy products during in-process and release testing.

Responsibilities

  • Direct technical and laboratory activities for all analytical and functional quality aspects within Quality Control in support of GXP manufactured cell or tissue-based products and platforms. Responsible for the establishment, oversight and execution of analytical activities for. This includes all products under IND in various phase clinical trials. Hands-on training, testing and data handling in addition to leadership and supervisory activities may be required.
  • As this is a leadership position with direct reports, a core function of the role pertains to the effective recruitment, on-boarding, development, motivation, and retention of employees
  • Work with Senior Management and QC staff to develop the skills and understanding of various technical processes, analytical testing, GXP regulations and leadership skills of the Quality Control team. Provide guidance and mentorship to staff, with accountability for the quality of their work.
  • Manage testing according to both GXP requirements and supply chain needs, ensuring tests are executed in accordance with written procedures and method validation, robust training is established and completed, and test performance and results are promptly reviewed.
  • Drive analytical method troubleshooting as well as lead investigations into Out-of-Specification and Out-of-Trend results and other testing discrepancies.
  • Support department budget compliance and coordinate any budgetary corrections or adjustments as needed. Balance resource allocation based on project priorities. Communicate effectively to staff and key partners and stakeholders.
  • Share the responsibility for representing QC aspects of Cell Therapy programs and decisions to health authorities and site/corporate senior leadership.
  • Collaborate closely with other cross-functional individuals and teams across the site in fulfillment of objectives.
  • Provide key strategic compliance and analytical input to projects and cross-functional teams, including process development, manufacturing implementation, regulatory submission preparation, and discussions with regulators. Serve as a technical interface and collaborate with Process Development in the development and technical transfer of multiple assays and methods from pre-clinical through commercialization including process and product validation, verification, qualification and optimization as needed to ensure efficient and rapid method transfer/qualification execution.
  • Communicate trends, performance data and any identified issues internally to teams, stakeholders, Quality, and Technical Operations management as well as any external laboratories or 3rd party suppliers/labs. Routinely provide data and trends to support IND filings, amendments, etc., and product stability/dating.
  • Lead team in working 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.
  • Establish working technical interfaced with other functional leads to improve operational efficiency and flexibility, including applying state-of-the-art cellular analytical techniques and methods.
  • Establish, implement, monitor and maintain testing and stability programs for raw materials, intermediates, final products and retains. Promote right first time QC results and activities, with testing established around critical materials, process capabilities, critical product attributes and established specifications/requirements.
  • Maintain Analytical Quality Control standards, ensure regulatory and quality compliance, participate in internal/external audits and inspections as required.
  • Ensure the control, review, verification and management of all Analytical QC data generated both manually and automated, including Certificates of Analysis documenting product testing results and analysis according to product specifications and requirements prior to QA approval.
  • Lead implementation of Laboratory Information Management System (LMS/LIMS).
  • Provide scientific guidance to process development, manufacturing, and QA teams relating to Analytical QC. Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends that are applicable to current and future operations and products.

Qualifications

Required

  • Minimum B.S. in Chemistry, Biology, Bioengineering or related scientific discipline, MS preferred.
  • 10+ years’ experience with analytical/functional Quality Control in GXP environments, including GMP, to meet all specifications and requirements (raw materials, intermediates, final product, sampling, release, stability, retains, data, systems)
  • 5+ years’ experience as a lead/supervisor of a scientific team
  • Experience in creating and establishing policy, procedures, and work flow for QC labs and testing programs
  • Strong understanding of federal regulations for Quality Systems (21CFR820), GMP manufacturing (21CFR210 and 211) and USP Compendial methods
  • 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
  • Demonstrated scientific creativity, technical proficiency and knowledge of scientific concepts
  • Culture of continuous approval, accountability, compliance and state-of-the-art methodology

Desired

  • Experience with GXP LIMS/LMS, ERP, MES and other automated quality / manufacturing / analytical tools preferred. Implementation of LMS / LIMS system a plus.
  • Previous industry or academic experience in CAR-T/cellular therapy research and development, including product characterization, method bridging, comparability, control strategy experience, a plus.
  • Previous experience in manufacturing, R&D, CMC, process/product development, a plus.
  • Flexible schedule

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