MSAT Specialist 2nd Shift
On-sitePhiladelphia, Pennsylvania, United States
Job Summary
Conduct manufacturing data analysis, root cause deviation investigations, and lead tech transfer steps for cell therapy processes. Execute MSAT laboratory activities, author protocols and reports, and oversee operations across multiple facilities. Perform Person-In-Plant responsibilities at CMOs to provide real-time feedback during GMP batch executions and train manufacturing personnel. Analyze process data to identify efficiencies and translate development reports into batch records and SOPs. Work Monday to Friday from 3pm to 11:30pm in an office and laboratory setting. This role supports Iovance Biotherapeutics' pioneering TIL therapy platform for cancer treatment.
Required Qualifications
- S degree in a relevant discipline
- 1 year of relevant hands-on operations experience for clinical or commercial production and/or process development experience in the life sciences industry
- Expertise in cell culture and aseptic technique
- Knowledge and understanding of GMP systems within a manufacturing facility
- Ability to organize and analyze manufacturing process data
- Knowledge of manufacturing process tech transfer
- Excellent oral and written communication skills
- Strong technical writing ability
- Ability to work cross functionally within the organization as part of a project team
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
- Must be able to move to and from the office to the lab located on separate floors and move about the office and lab as needed
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time
- Must be able to grasp with both hands, perform repetitious actions such as pinch with thumb and forefinger, turn with hand/ arm, and reach above shoulder height
- Must be able to use several types of laboratory equipment and pipettes for extended periods
- Must be able to work on a tablet or computer typing for 50% of a typical working day
- Must be able to move and lift 20 pounds multiple times daily
- Must be able to use near vision to view samples at close range
- Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics
- Must comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations
- Must wear proper personal protective equipment when in a laboratory setting, i.e., safety glasses, lab coats, and closed-toed shoes
- Clear and conceptual thinking ability
- Excellent judgment, troubleshooting, problem-solving, analysis, and discretion
- Ability to handle work-related stress
- Ability to handle multiple priorities simultaneously
- Ability to meet deadlines
- Must be available for Monday to Friday from 3pm to 11:30pm
Desired Qualifications
- Prior cell therapy experience
- Involvement in prior manufacturing process tech transfer
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.