Senior Aseptic Manufacturing Technician

Overview

Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL).  The company's lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma.  The company has Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors.  The company currently is developing its clinical and commercial manufacturing capacity to support development and launch of these assets. 

As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is strongly desired.

Essential Functions and Responsibilities

• Develop a Subject Matter Expert (SME)-level understanding of and be able to skillfully execute as well as troubleshoot 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.
• 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 may include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday, Thursday to Sunday, etc). May be required to work overtime.
• Support documentation needs, which may include drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Execute documentation Change Controls of SOPs, Batch records, etc. as needed.
• Support interdepartmental projects in a contributor capacity.
• Supports technical transfer and additional research level testing activities, as needed.
• Perform basic revisions as needed to accurately reflect current procedures.
• Support departmental projects in a contributor capacity.
• May support training sessions as a qualified trainer, ensuring training documentation is maintained.
• Assists with identification of training needs, establishing a feedback loop to ensure continuous improvement
• May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
• 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 or hold 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 ability to recognize deviation from accepted practice is required. 
• Other duties as assigned.

Basic Qualifications

• Bachelor's degree or some post-secondary education.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to mentor and provide best practices to new 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).
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Ability to build relationships quickly and credibly.
• Ability to work successfully in a fast-paced team-oriented environment.
• Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.

Preferred Qualifications

• Minimum 2+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors. May be given a visual exam for visual acuity and color perception.
• 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.
• May require up to 5% travel, based on business need.

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)

Physical Demands and Activities Required:

• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, 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%) of a 10-hr day 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.

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 deadline

Work Environment:

• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors. 

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 to change the duties of the position 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.

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