Director, Manufacturing Operations

Overview

The Director of Manufacturing Operations organizes, manages, and continuously improves the manufacturing operations and process for the new Iovance manufacturing site at 300 Rouse Boulevard, Philadelphia, PA. This individual is directly responsible for the operational teams that support clinical or commercial manufacturing as a value stream. This individual guides and oversees the process and production, ensuring material is made safely and compliant and meeting company targets. The Director is also responsible for developing a strategy to accommodate Iovance’s needs within the operations space as a growing organization.

Day shift: Monday to Friday from 7:30am-4:00pm

Essential Functions and Responsibilities

• Coordinate the initial production plan for clinical or commercial material on an annual basis that meets Iovance’s strategic objects and is compliant with cGMPs and safety regulations.
• Help develop schedules for manufacturing that meet monthly and quarterly targets. Ensure manpower 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 and MSAT to address these issues effectively and compliantly.
• Participate in tours or information requests for all agency and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.
• Develop and provide monthly manufacturing metrics and “Health of the Operations”
• Identify and implement continuous improvement opportunities for process and production related items. Expertise level in visual management, KPIs, huddle boards etc.
• Ensure the effective application of internal control systems and procedures applicable to each functional area of responsibility by providing management direction to operations personnel.
• Provide leadership to ensure the organization attracts, trains, develops and retains the best people and fosters an environment which motivates a diverse team to fully use its capabilities in achieving the desired business results
• 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

• Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
• At least 12 years of relevant operations experience for clinical and commercial production in the life sciences industry.
• A minimum of 10 years in a supervisory role, with increasing responsibility. Ability to manage and influence large teams within the manufacturing environment (potentially 50 employees)
• Solid knowledge of FDA regulations and GMP systems.
• Solid knowledge of human error reduction strategies, right-first time execution, and just culture.
• Demonstrated technical knowledge aseptic processing in cleanroom environments a must.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Project management skill set with experience in strategic/tactical planning, team building and meeting budgets.

Preferred Education, Skills, and Knowledge

• Cell and gene therapy experience 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.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, 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.

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 

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