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Director, Manufacturing Operations

2 months ago

Philadelphia, United States Iovance Biotherapeutics Inc Full time
Job DescriptionJob DescriptionSalary:

Overview

 

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

 

Shift: Monday to Friday from 11:00p - 7:30am


Essential Functions and Responsibilities

 

  • Coordinate the initial production plan for clinical or commercial material annually that meets Iovance’s strategic objectives and complies with cGMPs and safety regulations.
  • Help develop schedules for manufacturing that meet monthly and quarterly targets. Ensure workforce resources are adequate to complete operations and fully optimized from an operational excellence perspective.
  • Lead critical-level investigations related to the manufacturing and initial validation steps. Approve deviations, non-conformances, and CAPAs as required. Partner with Quality 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.
  • 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 that 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. in biochemistry, chemical engineering, bioengineering, 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 of aseptic processing in cleanroom environments is a must.
  • Excellent oral and written communication skills.
  • Strong technical writing ability is required.
  • Ability to motivate and mentor peers and staff and foster a culture of continuous improvement and operational excellence.
  • Self-motivated and willing to accept temporary responsibilities outside the 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.
  • Expert level in visual management, KPIs, huddle boards, etc.


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 remain in a stationary position standing or sitting for prolonged periods of time.
  • Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
  • Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
  • This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
  • Must be able to communicate with others to exchange information.

 

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 deadlines.

 

Work Environment

This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible.  Requires operating standard office equipment and keyboards.

 

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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