Senior Aseptic Manufacturing Specialist
2 days ago
We are seeking a highly skilled and experienced Aseptic Manufacturing Technician to join our team at Iovance Biotherapeutics Inc. As a key member of our autologous cell therapy manufacturing program, you will be responsible for executing and troubleshooting our GMP cell therapy manufacturing process.
Key Responsibilities- Develop a deep understanding of our GMP cell therapy manufacturing process and execute it with precision and attention to detail.
- Complete training sessions and maintain accurate training documentation.
- Ensure compliance with quality standards and requirements, including Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
- Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
- Perform document review, including executed Batch Records and Logbooks.
- Work collaboratively with the team to achieve manufacturing goals and objectives.
- Support documentation needs, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, and other documents.
- Execute documentation Change Controls as needed.
- Support interdepartmental projects and contribute to the development of new processes and procedures.
- Bachelor's degree or equivalent experience in a related field.
- Minimum 2+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Strong technical knowledge of aseptic processing in cleanroom environments.
- Ability to mentor and provide best practices to new technicians.
- Excellent communication and teamwork skills.
- Ability to work in a fast-paced team-oriented environment.
- Must adhere to Iovance Biotherapeutics Inc. core values, policies, procedures, and business ethics.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Proactive, results-oriented, self-starter with experience in a complex manufacturing environment.
- Ability to work successfully in a team-oriented environment.
This position will work in both an office and a manufacturing lab setting. When in the lab, you will be working with various chemical/biochemical exposures, including latex and bleach. You will also be working in a cleanroom with biohazards, human blood components, and chemicals. Potential exposure to noise and equipment hazards and strong odors.
Iovance Biotherapeutics Inc. is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
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