The culture at Carisma Therapeutics reflects the cutting-edge nature of the company’s work in developing novel immunotherapy treatments for human diseases. Employees come to work every day knowing their actions will have profound value. The team is a close-knit group and has cultivated an atmosphere that is fun and collegial but also goal-focused and fast-paced. There is great passion for advancing exciting and novel science while also building a successful company.

The Quality Control Manager will be responsible for support activities related to testing performed at contract organizations for our viral vector and cell product platforms that have now advanced into early phase clinical trials. Carisma is presently advancing an autologous cell therapy program using patient’s myeloid cells transduced with an adenoviral vector for the treatment of solid tumors. The QC Manager will assist in team management to support externally sourced projects, quality events, and documentation related to the assigned contract organizations evaluation of our viral vector and cell product platforms. The position will report to the Associate Director of Quality Control and will support the testing of final product samples, protocol development and qualification testing to support Carisma’s newly formed quality control department. We are looking for a detail oriented, quality minded, QC Manager to join our team and help develop the QC analytical methods and processes for our cell therapy products. The QC Manager will act as an interdepartmental liaison to various groups, including Analytical Development, Manufacturing, and Quality Assurance. The QC Manager will also conduct routine testing using analytical techniques for cell culture, flow cytometry, PCR and molecular biology, and cell-based potency assays. Candidates should have some expertise in technical writing and should exercise judgment and maintain a high level of compliance with applicable procedures, standards, and alignment with GMP regulations. This individual will be expected to help improve and develop systems to help the QC department in all areas.

Responsibilities:

• Along with other QC team members, manage product release testing activities at CMOs and contract labs to ensure the highest quality data is on time to support our clinical trials. This includes programs such as raw materials and reference standards.
• Participates in investigations related to assay failures, system deficiencies, deviations, and equipment / assay troubleshooting
• Participates in transferring and qualifying methods and procedures for new assignments as required
• Execute analytical method qualification, validation, and transfer into and out of the QC lab with QC team
• Manages projects in collaboration with other team members, both internally and at external sites
• Coach and mentor staff in all aspects of their job performance and career development
• Maintain an ever-ready state of compliance
• Help to establish the QC laboratory, including aspects related to facilities, instruments, processes, and procedures
• Prepare quality documents e.g. SOPs, technical documents, Investigations, review and approvals
• Update and maintain trending files, and provide routine summaries of trending to support investigations
• Responsible for resource management and initiating timely resource planning for the QC team based on production forecasts and business needs
• Conduct routine assays in compliance with company Standard Operating Procedures (SOP’s)
• Participate in the preparation of CMC regulatory submissions and associated Health Authority interactions (e.g., pre-approval inspections)
• Performance of flow cytometry, killing and phagocytosis assays, functional/potency bioassay, and titration assays to support testing for Process Development and CDMO/CMO
• Appropriately analyze data, interpret results, and maintain accurate laboratory notebook records; prepare and deliver presentations at team meetings
• Interact with internal cross-functional team members including Analytical Development, Process Development, Manufacturing, Nonclinical, Clinical, Quality Assurance, Regulatory, Legal, and Discovery
• Participate in the batch record review process, including escalation of issues and maintain timelines of reporting
• Perform other duties as assigned
• Domestic travel up to 25%
• Occasionally required to lift up to 20 pounds

Requirements:

• BS/ BA in biology, biochemistry, chemistry, or other science related field plus a minimum of 8 years of relevant experience. MS in Biochemistry, analytical chemistry, or related field plus a minimum of 6 years of relevant experience.
• 6 years within a GMP Environment within Biologics and/or Cell/Gene Therapy pharmaceutical manufacturing, with experience within a Quality leadership role
• Able to create and maintain highly functioning teams, cohesive, striving for common and individual goals, in a positive atmosphere for all employees. Able to coach and mentor more junior employees to success.
• Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.
• Ability to function in a rapidly changing environment and balance multiple priorities simultaneously
• Experience in cell-based assays, flow cytometry, MSD and ELISAs, PCR and other molecular based, HPLC and other physical/chemical-based technologies with expectations for significant expertise developing, optimizing and qualification or validation of assays with multiple technologies
• Knowledge and understanding of current Good Manufacturing Practices (cGMP), and current Good Laboratory Practices (GLPs) related to the QC Cell and Gene Therapy Laboratory
• Knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
• Highest moral and ethical integrity