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 Senior Quality Control Analyst will be responsible for evaluation of 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 position will report to the Associate Director of Quality Control and will be responsible for the analysis of in-process and final product samples, analytical-protocol development and qualification testing to support Carisma’s newly formed quality control department. We are looking for a detail oriented, quality minded, Sr. QC Analyst to join our team and help develop the QC analytical methods and processes for our vector reagents and the cell therapy products. The Sr. QC Analyst will also conduct routine testing using analytical techniques for cell culture, flow cytometry, and a variety of other release and characterization techniques, including PCR and molecular biology, and cell-based potency assays. Candidates should have some expertise for 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 assist in developing systems to grow and improve the QC department in all areas.

Responsibilities:

• Conducts routine and custom assays in compliance with company Standard Operating Procedures (SOP’s)
• Performance of flow cytometry, killing and phagocytosis assays, functional/potency type assays, MSD and ELISA assays, as well as titration assays to support testing for Process Development and Manufacturing at outside CDMO/CMO sites
• Appropriately analyze data, interpret results, and maintain accurate laboratory notebook records with both hard-copy and electronic versions; prepare and deliver presentations at team meetings
• Manages projects in collaboration with other team members, both internally and at external sites
• Maintains and calibrates equipment
• Maintenance of data integrity and logs for equipment, including the review of logs
• Familiar with molecular biology techniques such has DNA isolation using automated platforms, qualitative PCR, digital PCR, and gel electrophoresis
• Perform peer review of laboratory data. May approve laboratory data.
• Utilize electronic systems (LIMS, ELN, etc.) for execution and documentation of testing and sample management
• Responsible for aseptic handling of reagents and products including tissue culture
• Participates in investigations related to assay failures, system deficiencies, deviations, and equipment / assay troubleshooting, with assistance
• Updates and maintains trending files, and provides routine summaries of trending to support investigations
• The analyst may participate in designing, transferring and qualifying or validating methods and procedures for new assignments as required
• Execute analytical method qualification, validation, and transfer into and out of the QC lab with mentorship from other team members
• Maintain individual training records in a compliant state
• Work effectively in a team environment as well as contributing individually
• Perform other duties as assigned
• Domestic travel potentially up to 5%
• Occasionally required to lift up to 20 pounds

Requirements:

• A minimum of a bachelor’s degree in Biology, Biochemistry, Microbiology, Chemistry or related field, with a minimum of 2 years’ experience in Quality Control or related analytical support organization
• Highest moral and ethical integrity
• Detailed knowledge of one or more of the analytical technologies used in the Cell and Gene Therapy Laboratories such as qPCR, cell culture, flow cytometry, and ELISA or MSD
• Experience with cell culture is required
• Skilled in performing basic and some advanced biological testing within the functional laboratory
• Knowledge and understanding of current Good Manufacturing Practices (cGMP), and current Good Laboratory Practices (GLPs) related to the QC Cell and Gene Therapy Laboratory
• Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
• Basic technical writing skills
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
• Proficient with using Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)