Associate Director, Quality Control
Job Title: Associate Director, Quality Control
Schedule: Full-time
Location: Louisville, KY
About Regenerex
Regenerex is a biopharmaceutical company based in Louisville, KY. The mission of Regenerex, LLC is to make the proprietary Facilitating Cell platform technology (FCRx) widely available to treat many disorders with unmet need. The FCRx product eliminates the need for a perfectly matched donor, thereby allowing nearly any candidate for a stem cell transplant to receive the treatment. Hematopoietic stem cell transplantation (HSCT) has been used to successfully treat inherited metabolic enzyme disorders, red blood cell disorders, to induce tolerance to organ transplants and to treat autoimmune disorders such as type 1 diabetes, multiple sclerosis, rheumatoid arthritis and scleroderma.
Regenerex has established a collaborative relationship with the University of Louisville’s Institute for Cellular Therapeutics (ICT) to expedite translation of discoveries from bench to bedside. Company and university scientists work together to manufacture the FCRx product and study the mechanism of action of the facilitating cell in this unique translational research environment.
Regenerex requires dedication and a willingness to accept a variety of tasks and responsibilities at all times. Employees must always operate with the highest degree of integrity, be motivated, thoughtful, and dedicated to supporting the long term development of a technology with the potential to improve thousands of lives.
Job Description
The Associate Director of Quality Control is responsible for the management of QC and analytical testing of cell therapy products manufactured within the Regenerex facility. The facility is a state-of-the-art, GMP and GTP compliant, controlled clean room facility designed for the production of novel regenerative medicine products. The Associate Director will be responsible for planning Quality Control operations and managing a team of scientists and technologists to conduct analytical testing in a reproducible manner to assure the product meets established criteria for safety, efficacy and purity. The position requires an exceptional technical leader with a thorough understanding of cell-based methodologies, a solutions-oriented approach to problem solving, and outstanding team management skills.
The Associate Director of Quality Control will report to the CEO.
Primary responsibilities:
Plan and manage Quality Control operations conducted within the Regenerex facility in a manner that assures reproducibility and compliance with 21 CFR 210, 211 (Good Manufacturing Practices) and 21 CFR 1271 (Good Tissue Practices); serve as responsible head of analytical operations
Develop a strong team of highly skilled scientists and technologists responsible for conducting analytical testing on cell therapy products within a cGMP regulated laboratory; define roles, establish clear expectations, assure appropriate training, motivate team members, support career development and manage performance
Ensure method validation for current analytical testing, including flow cytometry, endotoxin, cell counts, cell viability and potency assays
Manage analytical reviews of cGMP documentation including Master Batch Records, Certificates of Analysis, Research and Development protocols and reports, and other cGMP records.
Develop departmental strategic plans in line with company objectives and prioritize projects with an emphasis on compliance, execution, adherence to detail, and continuous quality improvement
Coordinate analytical operations with Manufacturing, Quality Assurance, and administration to assure seamless integration of operations, timely batch record review, and product release
Collaborate with R&D scientists at Regenerex to coordinate research processes and integrate operations to prepare for production of cell therapy products for new indications
Work closely with Regulatory and Quality staff within and outside of Regenerex to build consensus on approaches to assure that regulatory requirements are met
Work closely with Quality Assurance and Manufacturing leadership to represent Regenerex in third party inspections, including Food and Drug Administration inspections
Secondary Responsibilities:
Assess Quality Control team capacity and collaborate with Associate Director, Cell Processing Operations to develop recommendations for team structure, manufacturing timelines, and operational improvements
Manage analytical activities in accordance with available budget, resources and personnel
Play significant role in interviewing, hiring and training analytical staff
Provide guidance and leadership for investigations of Out of Specification results in analytical testing
Assist in conducting root cause analysis of non-conformances from normal operations related to Quality Control activities, work with Quality Assurance to implement corrective and preventive actions (CAPA) where required
Review and approve technical and regulatory reports, new SOPs and significant SOP revisions; participate in writing reports and SOPs as needed
Maintain substantial current technical knowledge related to all procedures relevant to cell processing and analysis, aseptic processing operations, regenerative medicine product manufacturing and other relevant fields
Perform additional job related duties as required
Minimum Requirements
PhD in the biologic sciences with 10+ years of experience in cell therapy, gene therapy, or related field
Thorough understanding of the field of cell therapy processing and cryopreservation
Experience leading a laboratory group and managing analytical testing within a cGMP/cGTP compliant biotech or cell processing (i.e., stem cell or bone marrow processing) facility, with 5+ years of supervisory experience
Background in flow cytometry and familiarity with common cell processing equipment and techniques
Expertise in analytical method development, analytical method validation, and statistical quality control
Thorough understanding of applicable regulations and standards for processing and analytical testing of cellular therapy products for Phase I, II and III trials (GMP, GTP, AABB, ICH, USP), particularly as related to analytical method development and validation
Strong technical writing skills, including preparation of validation and qualification studies, batch records
Demonstrated ability to effectively manage others, manage performance, set and prioritize departmental goals
Excellent time management and organizational skills, demonstrated ability to manage multiple projects and meet deadlines
Please note: an equivalent combination of education, training, and/ or professional experience may be considered in substitute for the requirements listed
Additional Qualifications
Ability to work effectively in a fast-paced, rapidly changing environment
Excellent people skills, with demonstrated ability to manage a diverse team and communicate effectively across functional groups
High level presentation and writing skills, with experience reporting to senior leadership
Relevant experience in technology transfer of analytical assays a plus
Experience working in both academic and corporate settings a plus
Willingness to have a flexible schedule when needed and travel domestically and internationally on occasion
Apply: Please submit resume or CV and cover letter to hiring@regenerex.com
Regenerex is an equal opportunity employer and prohibits unlawful discrimination.
