Supervisor, Manufacturing Specialist Job at Iovance Biotherapeutics Inc in Phila

Iovance is hosting an onsite Job Fair. 

Where: Iovance Cell Therapy Center (iCTC)  

Location: 300 Rouse Blvd Philadelphia, PA 19112  

Date: Wednesday, October 23, 2024 

Time: 12pm to 6pm (EDT)   

What to bring: Updated hard copy resume

We are Hiring!  We look forward to seeing you at the Job Fair. 

Overview

The Supervisor, Manufacturing Specialist oversees the manufacturing specialist group within the Iovance Cell Therapy Center (iCTC).  This role will execute manufacturing change management at the iCTC facility, including manufacturing investigations, document authoring / editing and deviation management.  The Supervisor will also oversee special projects related to continuous improvement or new product introduction in support of the manufacturing group. 

Essential Functions and Responsibilities

• Oversees 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 - 5 years of relevant operations experience for clinical and commercial production in the life sciences industry. 
• A minimum of 1 year in a supervisory role or corresponding experience in people management.
• 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.
• 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

• Experience with cell therapy products is a plus.
• PMP certification is preferred.
• 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.
• 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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