Manager, Quality Control Sterility Assurance

Overview

Iovance seeks a highly motivated Manager, Quality Control (QC) Sterility Assurance.  The incumbent is responsible for assisting in the development and oversight of the implementation of all microbial contamination control processes/procedures and is accountable for assisting in establishment of a robust and comprehensive microbial contamination control programs for the company’s clinical and commercial programs at two manufacturing sites in Philadelphia.

This role will effectively collaborate with multiple stakeholders to ensure the harmonized execution of contamination control policies across the two manufacturing sites in Philadelphia. This role will also support new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods.     

The Manager, QC Sterility Assurance will have strong leadership and substantial experience leading QC sterility assurance programs in a Pharmaceutical or Biotechnology environment.

The QC Sterility Assurance Manager is a key support role and reports to the Associate Director, QC Sterility Assurance.

Specific Responsibilities:

• Championing sterility assurance principles at the site in the areas of aseptic processing, and contamination control.
• Support the site compliance to the global microbial control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, clean-room management, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments.
• Assist with the design of the contamination control strategy.
• Develop and maintain microbial contamination/Cross contamination risk assessment (HACCP).
• Assist in developing and maintaining the EMPQ strategy and provides oversight of the EM testing program for regulatory compliance and technical soundness.
• Develop EM and Utility trending reports within deadlines, for the 2 sites in PA.
• Supports the Aseptic Process Simulation (APS) as a Sterility Assurance SME.
• Assist with the Annual Product review (APR) reports with the environmental monitoring data.
• Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial controls.
• Assist with relevant internal and external inspection responses/action items related to contamination control issues.
• Establishes and implements appropriate training programs in collaboration with training leads.
• Ensure alignment and harmonization regarding global microbiological/aseptic standards, policies, practices, procedures and compendial/regulatory requirements across sites.
• Plays a critical role in facility design and modification, cleaning and sanitization program, operator qualification, gowning certification, manufacturing support, training, investigations, inspections, and audits.
• Participates as microbiology SME in inspections defending contamination control strategy, and associated EM trend reports.
• Troubleshoots contamination related issues occurring in internal and external manufacturing sites.
• Support site QC in microbiology deviations, LIR, OOS, Change controls and CAPA records.
• Performs video reviews and assists compliance team with identification of proper root cause analysis for EM related deviations.  Approves and trends EM related deviations routinely.
• Owns change control tasks associated with qualification or program revisions.
• Runs the EM Task Force meeting and regularly communicates with senior levels of management for issues related to contamination control.
• Champions new initiatives and acts as the catalyst for microbiology related changes within QC and potentially across divisions.
• Assist with new product transfers related to microbial method validations and rapid microbial methods.
• Reviews and provides oversight for microbial testing performed at contract laboratories.
• Participates in continuous improvement and implementing best practices (ensuring understanding/ compliance with SA related regulations and guidance.
• Performs regular GEMBA style assessments of the aseptic process on site to assess compliance of operations including identification of deficiencies and provide real time coaching to aseptic staff.  Perform routine audits of the manufacturing areas.
• Authors new and revised procedures for Sterility Assurance department.
• Ability to work in a team environment and independently as required. Maybe required to work Holidays and weekends.
• Ability to evaluate technical data and write technical documents.
• Advanced data integrity knowledge and practices.
• Intermediate understanding of statistics, control charts, action, and alert limits.
• Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.

Education and Qualifications:

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent), advanced degree preferred.
• Minimum Six (6+) years of experience in the pharmaceutical industry within a Quality Control microbiology role; experience with cell therapy products is a plus.
• Demonstrate knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology. Knowledge and familiarity with Annex 1.
• Strong knowledge of microbiological control strategy, environmental monitoring, clean room qualification and management, and media fills required.
• Knowledge and familiarity with sterility testing, endotoxin, and mycoplasma testing.
• Broad knowledge of quality control for biologics with experience in microbial contamination control.
• Experience with microbiological risk assessments.
• Successfully interface with multi-disciplined teams.
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• High level of ownership and accountability
• Demonstrate sense of urgency; ability to recognize time sensitivity.
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders.
• Flexible and adaptable style with an eagerness to take on challenges.
• Problem solver who not only identifies issues but leads efforts to resolve them.

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:

• 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.
• Must be able to use near vision to view samples at close range
• 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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