Manager, Manufacturing Operations

Overview

Iovance is seeking a Manager to join the Manufacturing Operations team at 700 Spring Garden St, Philadelphia, PA (IOVA-A). 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. This role will provide guidance and oversight to the process and production as well as timely document review, ensuring material is made safely and compliant and meeting company targets.

This individual will be directly responsible for the teams who make up either upstream or downstream manufacturing, whose direct responsibilities include producing product on the manufacturing floor. The Manufacturing Manager will also be responsible for the development of staff, ensuring a highly effective "Right First Time" program, to accommodate Iovance's needs as a growing organization.

The Manager should demonstrate innovative technical knowledge, and will significantly contribute to the overall manufacturing operation.

Essential Functions and Responsibilities

• Oversees the Manufacturing Operations team to support startup and clinical production and a scale-up plan for commercial material to support Iovance's strategic objectives.
• Provides visionary leadership for all aspects of sterile drug production, overseeing the entire manufacturing process and ensuring that production, performance, safety, and quality standards are continuously met.
• Walks the production areas daily to review and ensure that operations are in a state of control.
• Develop schedules for manufacturing that meet monthly and quarterly targets. Ensure resources are adequate to complete operations and fully optimized from an operational excellence perspective.
• Lead critical level investigations as related to the manufacturing and initial validation steps. Approve deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.
• Identify, lead, and implement continuous improvement opportunities for process and production related items. Expertise level in visual management, KPIs, huddle boards etc. Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of the operation.
• Ensure batch-related documentation (batch records and SOPs) is closed in a timely manner to support batch release. Since it is a just-in-time manufacturing process, careful coordination and communication will be required between Operations, Quality Release and Supply Chain team.
• Maintain robust training program to ensure timely, efficient, and effective training of individuals. A highly effective "First time right" program is required for autologous cell therapy.
• Leads tours and information requests for all agency and internal audits of the manufacturing facilities/processes, and responds to any observations received per procedure.
• Develop and provide monthly manufacturing metrics and "Health of the Operations"
• Lead personnel actions to include recruiting, onboarding, performance management, training, promotions, transfers, etc.
• Supervision and development of direct reports, mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.
• Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely feedback to Management.
• Author and revise documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
• Ensure the department understands and complies with quality standards and requirements as documented. Ensure efficient operations, and compliance with cGMPs and safety regulations.

Basic Qualifications

• Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience. As this person will be the responsible for oversight of the manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is required. Cell/gene therapy experience is preferred.
• Minimum of 3 years in a leadership role with increasing responsibility, or an equivalent combination of education and experience.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments
• Strong knowledge of and experience in in-lab skills training, including aseptic technique and cell culture processing.
• People management skill set with experience in team building, empowering employees, active listening, conflict-resolution, organization, flexibility, patience, clear communication, and trust.
• Ability to build relationships quickly and credibly. Provide consistent, excellent support to entire staff, with the ability to manage and influence large teams within the manufacturing environment representing a variety of personalities and experience levels. 
• Ability to motivate and mentor peers and staff as well as foster a culture of continuous improvement and operational excellence.
• Experience leading “development” initiatives, i.e., training, coaching, learning initiatives.
• Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment. 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. Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
• Demonstrated project management skills with experience in strategic/tactical planning. Excellent oral and written communication skills.
• Strong technical writing ability required. Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
• Solid knowledge of FDA regulations and GMP systems. 
• Solid knowledge of human error reduction strategies, right-first time execution, and just culture.
• Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.
• May require 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.

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.
• Ability to stand/sit/walk for long periods of time.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Ability to lift 20 lbs.

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 setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Must be able to work in cleanroom lab setting with biohazards / various chemicals
• Potential exposure to variable noise levels, equipment hazards, strong odors, latex, bleach, 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 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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