Overview:
As an Aseptic Processing Technician, you will focus on the documentation for our processes. The ideal candidate will 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.
Shift: 10 Hour Day Shift, Tuesday - Friday; 7:00am - 5:30pm
Essential Functions and Responsibilities:
- Complete training sessions and ensure training documentation is maintained.
- Proficiently carry out procedures to achieve a consistent, error-free execution of daily job assignments
- Work as part of a team to produce each lot accurately and fully complete batch records, forms, and documentation.
- At all times, understand and comply with quality standards and safety guidelines.
- Perform materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
- Identify errors and report them promptly to lab management. Participate in root cause analysis and implement corrective actions.
- Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
- 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% of travel
Required Education, Skills, and Knowledge
- Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
- 0-2 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- 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.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
Preferred Qualifications:
- Demonstrated technical knowledge of aseptic processing in cleanroom environments.
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.
For the Visual Inspection Program, the technician must be able to pass a Vision Exam that includes the following:
- Must not be color
- Must have 20/20 near vision in both eyes (can be corrected)
Physical Demands and Activities Required:
- Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
- 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.
- Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Ability to lift 45 lbs.
Mental
:
- 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; and ability to meet deadlines.
Work Environment:
- This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.
