Overview

Iovance Biotherapeutics is seeking a Manager, Manufacturing Services to join the Operations team at 700 Spring Garden St, Philadelphia, PA. Co-located at the American Red Cross Penn Jersey Region, this Iovance facility produces a critical raw material used in the company’s tumor infiltrating lymphocyte (TIL) process. The critical raw material is processed from leukapheresis units and frozen. Processing is performed in an ISO 7 cleanroom within an ISO 5 biological safety cabinet.

Iovance is an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on 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 commercial manufacturing capacity to support development and launch of these assets.

The Manager, Manufacturing Services will provide leadership in the activity based learning space and the manufacturing specialist group. The manager is expected to lead and develop a team of training specialists and manufacturing specialists.

This role will be directly responsible for maintaining and continually improving a formal training program for the manufacturing operational team and, as necessary, collaborating with the quality departments to execute their training program. This individual is expected to lead and develop a team of training specialists to undertake the training program.

This role will execute manufacturing change management at the IOVA-A facility, including manufacturing investigations, document authoring / editing and deviation management. The manager will also oversee special projects related to continuous improvement or new product introduction in support of the manufacturing group.

Essential Functions and Responsibilities

•  Training:
  • Identify training needs, work with manufacturing leadership to develop an organizational training strategy and curriculum, oversee its implementation, evaluates effectiveness through competency testing, and establish a feedback loop to ensure continuous improvement.
  • Develop a training schedule, coordinate the staffing and scheduling of in‐house and field training.
  • Plan curriculum design and support documentation, including drafting and approval of SOPs.
  • Training and development of staff, including mentoring/coaching to motivate and mentor staff, to foster a culture of continuous improvement and operational excellence.
  • Deliver training sessions and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
  • Ensure efficient operations, and compliance with cGMPs and safety regulations.
  • Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of training.
  • Work with operations leadership to define and track key performance indicators to measure training effectiveness.
  • Create processes that enable timely and actionable performance feedback of trainees.
  • Develop an understanding of current production process
  • Ensure the training team understands and complies with quality standards and requirements as documented.

• Technical Writing and Compliance:
  • Oversee and manage day to day activities of the Manufacturing Specialist Group.
  • Responsible to lead deviation and investigations related to manufacturing operations.
  • Review deviations, non-conformances, and CAPAs as required.
  • Partners with Quality and other cross-functional groups to address issues effectively and compliantly.
  • Manages external contractors who support deviation investigations and closure for manufacturing operations.
  • Coordinates with team members responsible for procedure and batch record changes to support remediation, continuous improvement, or new product introduction across clinical and commercial value streams.
  • Develops and provides monthly operations metrics and indicators focused on specialist team performance and across manufacturing value streams.
  • Identifies and manages projects for continuous improvement opportunities in manufacturing operations in collaboration with the Operational Excellence group and other manufacturing management members.
  • Maintains team capability and readiness via training, performance reviews, and hiring new manufacturing specialist when necessary.

Required Education, Skills, and Knowledge

• Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
• A minimum of 3 years in a leadership role or corresponding experience in people management.
• Strong Project Management skills combined with a structured and solution‐oriented work approach
• Solid knowledge of FDA regulations and GMP systems. 
• Solid knowledge of human error reduction strategies, right-first time execution, and just culture.
• Demonstrated project management skills.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Ability to motivate and mentor peers and staff as well as foster a culture of continuous improvement and operational excellence.
• Excellent communication skills and interaction with internal and external interfaces
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

Preferred Education, Skills, and Knowledge

• Manufacturing experience, ideally in a Biopharmaceutical environment and/or Cell and Gene Therapy.
• Lean Practitioner and certified Green Belt preferred, ideally Black Belt Certification
• Fluent in Microsoft Project or comparable software 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:

• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
• Must meet requirements for and be able to wear a half-face
• 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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