Associate Aseptic Manufacturing Technician [Contract to Hire]

Overview

The Associate Aseptic Manufacturing Technician is an entry-level position for our autologous cell therapy manufacturing program. As an Associate Aseptic Manufacturing Technician, you will be responsible for learning and completing various tasks, such as cleaning, sanitization, preparation, and the process for fulfilling products for commercial and clinical use. To excel in this role, the candidate will need to have the ability to work in a fast-paced environment, learn about cell culture, wear an aseptic gown, and understand 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 successful completion of our manufacturing process.

Essential Functions and Responsibilities

• Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
• Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
• Complete training sessions and ensure training documentation is maintained.
• Understand and comply with quality standards and requirements as documented. 
• 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 questions/issues/concerns at that forum to Area Management for further investigation.
• Work in a cleanroom with biohazards, human blood components, and chemicals
• 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.

Required Education, Skills, and Knowledge

• High School Diploma or GED.
• 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 and adjust to constant change.
• Must read, write, and understand English, especially for Good Documentation Practices
• Proficient with computers and Microsoft (Excel, Word, Outlook) programs.
• Ability to comprehend, execute, and reproduce arithmetic calculations, including fractions, decimals, and percentages, and basic algebraic and geometric calculations.
• Good communication skills, both written and verbal
• Ability to work successfully in a fast-paced, team-oriented environment.
• Proactive, results-oriented, self-starter

Preferred Education, Skills, and Knowledge

• Bachelor's or post-secondary education, including a biomedical technician training
• Prior experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility.
• Familiar with 21 CFR Part 11 and standard GxP best practices and FDA

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 blind.
• Must have 20/20 near vision in both eyes (can be corrected)
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
• Able to complete 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 motion
• Must be able to lift and carry objects weighing 45 pounds

Mental:

Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to manage 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.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position’s responsibilities at any time.

Iovance 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. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.

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