Aseptic Processing Technician I [Contract to Hire]

Iovance Biotherapeutics•Philadelphia, PA

17h•Onsite

About The Position

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system. The Aseptic Processing Technician I role is crucial for the iPBMC used in the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. The Aseptic Processing Technician I will be responsible for various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use. To excel in this role, it is strongly desired that the candidate has a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations. This position works across different shifts, and depending on the assigned shift, may require working on weekends and holidays.

Requirements

Minimum B.S./B.A. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
Minimum 0-1 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
Must be able to deal with ambiguity – ready to change gears and plans quickly and manage constant change.
Able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
Able to accurately perform basic math, including fractions, decimals, and percentages.
Able to work effectively with team members and show initiative to assist others on the team.
Able to work successfully in a fast-paced, team-oriented environment.

Nice To Haves

Proactive, results-oriented, self-starter with experience in a complex manufacturing environment.
Demonstrated technical knowledge of aseptic processing in cleanroom environments.
Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA.

Responsibilities

Develop a comprehensive understanding of and be able to execute Iovance’s GMP proficiently.
Complete training sessions and ensure training documentation is maintained.
Completes recording of data to comply with regulatory requirements.
Perform document review, including executed Batch Records and Logbooks.
Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
Identify errors and report them promptly to area management. Participate in root cause analysis and implement corrective actions.
Ability to work in a team environment and independently as required.
Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
Perform miscellaneous duties as assigned.