CONTRACT
MUST HAVES:
- Bachelor's degree or some post-secondary education and 1 year of GMP cell or gene therapy manufacturing experience
Overview:
The Aseptic Manufacturing Technician I/II/III role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. As an Aseptic Manufacturing Technician I, you will be responsible for various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use. To excel in this role, the candidate strongly desires to have a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations. 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.
Essential Functions and Responsibilities:
- Develop a comprehensive understanding of and be able to proficiently execute Iovance’s GMP cell therapy manufacturing process(es).
- Complete training sessions and ensure training documentation is maintained.
- Understand and comply with quality standards and requirements as documented.
- 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.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
- Attend the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
- 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.
- Must adhere 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.
- Travel - Up to 5% travel, based on business needs.
Required Education, Skills, and Knowledge:
- Bachelor's degree or some post-secondary education.
- 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.
- Must be able to read, write and understand English for Good Documentation Practices
- Proficient in Microsoft (Excel, Word, Outlook).
- Ability to perform arithmetic calculations, including fractions, decimals, and percentages, and basic algebraic and geometric calculations accurately and reproducibly.
- 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 build relationships quickly and credibly.
- Ability to work successfully in a fast-paced, team-oriented environment.
For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:
- Must not be color blind.
- Must have 20/20 near vision in both eyes (can be corrected)
- Clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors may be given a visual exam for visual acuity and color perception.
Physical Demands and Activities Required:
- Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing 45 pounds.
- The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
