As a Lead Aseptic Manufacturing Technician, you will be overseeing the overall execution of various tasks within the cleanroom suite such as hands-on cell processing using single use high density bioreactors, Bio Safety Cabinets (BSCs), visual inspection and cryopreservation of final product, cell count machines, cell wash and concentration machines, tube welders and sealers, environmental monitoring, cell culturing, and liquid transfers for commercial and clinical use. The role primarily takes place in grade C (ISO8) and Grade D (ISO 9).
This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the manufacturing process is completed.
This individual is a seasoned professional and a crucial member of our autologous cell therapy manufacturing program. The Lead Aseptic Manufacturing Technician will provide expert leadership and guidance to a team of Senior and Aseptic Manufacturing Technicians. You will ensure adherence to Good Documentation Practices (GDPs) and proper Aseptic Techniques within a cleanroom environment. Your proficiency in cell culture techniques, aseptic gowning procedures, and equipment troubleshooting will be essential in contributing to efficient operations and minimizing downtime. Additionally, you will serve as a Subject Matter Expert (SME) for aseptic techniques, providing training and support to team members. Your role will be crucial in ensuring that quality standards and regulatory guidelines are met.
Shift A-Rotation-Confirmed
OR
Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training for this position will occur during regular work week hours (1st shift M-F); however, once the technician is trained, they will be assigned to a shift that include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday) May be required to work overtime.
Essential Functions and Responsibilities:
• Develop a Subject Matter Expert (SME)-level understanding of and be able to skillfully lead, oversee and execute as well as troubleshoot GMP cell therapy manufacturing process(es).
• Subject matter expert (SME) responsible for ensuring and enforcing strict adherence to proper aseptic technique among all team members.
• Ensures aseptic operations within grade A Biological Safety Cabinet (BSC) functions are strictly followed, such as:
o Manipulations within the BSC.
o Aseptic liquid transfer.
o Measures and weighs for in-process materials.
• Responsible for ensuring all activities on assigned operations are complete and executed in a compliant manner. (i.e., Batch record review, flask handling and storage, final product inspections, cryopreservation, inventory management system transactions, chain of information, chain of custody transactions, materials stocking and transfer, kit preparation, and room readiness.
• Ensures the team understands, adheres and complies with Safety SOPs, SDS sheets, current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP) and laboratory procedures per company policy and OSHA regulations.
• Assist supervisor(s) and coordinator to ensure adherence to production schedule while maintaining internal production priorities.
• Complete tier 1 KPI reporting form at end of shift.
• Attend or drive the daily Tier 1 meeting in the absence of a supervisor or as required and escalate issues/concerns at that forum to Area Management for further investigation.
• Triages equipment troubleshooting and any other escalations.
o Clearly and timely communicates and escalates to the proper support team (i.e., QO, Operations Supervisor, Specialist, Area Manager).
• Primary Responsibilities:
o Grade A/ISO 5, BSC grade B/ISO 7/Bench:
? Oversees, and provides training for in-suite operational functions.
o Hallway and Preps:
? Oversees, and provides training for hallway and preps operational functions.
Miscellaneous
• Assists with identifying training needs, establishing a feedback loop to ensure continuous improvement.
• Ensure mathematical calculations are done accurately.
• Ensures aseptic tube welding, sealing and connections are done correctly.
• Ensure all in-process samples are collected and submitted.
• Ensure all executed records are complete and accurate.
• Ability to lead, organize, execute, and 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.
• Leadership acumen, ability to prioritize, proactive, results oriented, self-starter with experience in a complex manufacturing environment.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.
• Able to train, pass and maintain gowning qualification.
• Able to train, pass and maintain APQs (Aseptic Process Qualifications).
• Performs documentation needs, which include drafting and reviewing of SOPs, Work Instructions, Forms, Batch Records, Deviations, CAPAs, etc.
• Facilitate comprehensive training sessions as a certified trainer. Ensure clear, concise guidance and maintain meticulous training documentation, adhering to strict Good Documentation Practices (GDPs).
• Identifies training gaps and needs, establishing a feedback loop to ensure continuous improvement.
• Support departmental projects in a contributor capacity.
• To be trained in all different roles
Required Education, Skills, and Knowledge
• Bachelor's degree or relevant experience.
• Minimum 3+ years of experience in biopharmaceutical-based GMP manufacturing operations, including, aseptic technique, aseptic liquid transfers, use of welders and sealers, BSC aseptic operations and associated downstream processing is a plus.
• Ability to oversee, lead and drive cleanroom activities while building relationships quickly and credibly
• Ability to perform arithmetic calculations accurately and reproducibly, including fractions, decimals, percentages, and basic algebraic and geometric calculations.
• SME demonstrated a level of understanding and technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to oversee floor operations, mentor and provide best practices to all levels of technicians.
• Must be able deal with ambiguity – ready to change gears and plans quickly, able to manage constant change.
• Must be able to read, write and understand English especially for Good Documentation Practices, and be proficient in Microsoft (Excel, Word, Outlook and Teams).
• Ability to work successfully in a fast-paced team-oriented environment and independently as required
• Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.
Preferred Education, Skills, and Knowledge
• Minimum 3+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing, including but not limited to cell culture, single use high density bioreactors, Bio Safety Cabinets (BSCs), cell count machines, liquid transfers, cell wash and concentration machines, tube welders and sealers, controlled rate freezers, grade B (ISO7) gowning and liquid nitrogen amongst others.
• Leadership and Quality mindset, familiar with 21 CFR Part 11, standard GxP best practices and FDA regulations.
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