Senior Manager, Quality Control, External Operations (IOVA-A)

Overview

The Senior Manager, Quality Control, External Operations (IOVA-A) is a part of Quality Control testing Operations at Iovance’s IOVA-A facility located within American Red Cross (ARC) in Philadelphia, PA. This Iovance facility produces a critical raw material used in the company’s TIL process. The quality control testing programs at IOVA-A include the responsibility to performs iPBMC (irradiated peripheral blood mononuclear cells) lot release, stability testing, tech transfer, method qualification and validation, lot release, and writing/review of QC procedures. Typical test methods performed include Cell Counts (automated NC200) and Cell Proliferation, etc.

Essential Functions and Responsibilities

• The Quality Control Senior Manager directs and supervises the functions of the IOVA-A QC department such as laboratory testing, lot release, tech transfer, method validation, and inspections.
• Responsible for leading and training in all IOVA-A QC functional Oversight of all aspects of efficient daily GMP quality control laboratory testing activities at the IOVA-A facility.
• Manage QC personnel engaged in Testing activities to ensure final products is released and meet defined specifications throughout production life – cycle.
• Helps to ensure compliance to cGMPs and facility Interface with functional groups, such as Quality Assurance, Manufacturing, MSAT and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.
• Review and confirm QC test methods, reports, test data and other various records to support product lot release with adherence to turnaround times
• Support thorough GMP investigations for out of specification test results and other quality events.
• Support method qualification, validation, and tech transfer to internal and external laboratories.
• Champion operational excellence improvements such as Lean Labs.
• Trending of analytical performance.
• Support Health Authority inspection. 
• Must be willing to work weekends, evenings, and holidays, as needed. 
• 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

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
• Minimum (9) years of experience in the biopharmaceutical industry within a Quality Control role
• Relevant experience in a cGMP QC environment
• Experience with analytical test method validation and transfers
• Understanding of relevant cGMP, ICH, and other global regulatory guidance
• Strong oral, written communication, and interpersonal interaction skills
• Strong organization and problem-solving skills
• Able to balance priorities while maintaining a high level of productivity and compliance standard. High level of ownership and accountability
• Successfully interface with multi-disciplined teams in a global setting
• Flexible and adaptable style with an eagerness to take on challenges

Preferred Education, Skills, and Knowledge

• Experience with cell and/or gene therapy products is a plus
• Experience with regulatory inspections is preferred

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.

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 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.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Ability to lift 20lbs. 

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:

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

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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