Quality Control Lab Technician
Philadelphia, PA (B.labs)
Manufacturing and Development – QC /
Full-time
/ On-site
The Quality Control Lab Technician will be responsible for testing 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 position will report to the Quality Control manager and will be responsible for the analysis of in-process and final product samples to support Carisma’s newly formed quality control department.
We are looking for a detail oriented, quality minded laboratory technician to join our team. The QC Laboratory Technician will 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 exercise judgment and maintain a high level of compliance with applicable procedures, standards, and alignment with regulatory guidance.
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 assays, as well as titration assays to support testing for Process Development and Manufacturing for Carisma and CDMO/CMO sites
- Appropriately analyze data, interpret results, and maintain accurate laboratory notebook records with both hard-copy and electronic versions
- Maintenance and calibration of equipment
- Maintenance of data integrity and logs for equipment
- Familiarity with molecular biology techniques such has DNA isolation using automated platforms, qualitative PCR, digital PCR, and gel electrophoresis
- Utilize electronic systems (ELN, etc.) for execution and documentation of testing and sample management
- Responsible for aseptic handling of reagents and products including tissue culture
- Assist in analytical method qualification, validation, and transfer activities under the leadership of 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 experience in Quality Control or related analytical support organization a plus
- Highest moral and ethical integrity
- Basic knowledge and experience with 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
- Experience with performing basic biological testing within a laboratory
- Knowledge of current Good Manufacturing Practices (cGMP), and current Good Laboratory Practices (GLPs) related to the QC Cell and Gene Therapy Laboratory
- 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)
Carisma Therapeutics is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Carisma Therapeutics is proud to be a 2021 Best Places to Work Honoree.
