Manager Manufacturing Operations-2nd shift-Monday to Friday

Overview

In this position one provides guidance and oversite to the process and production as well as timely document review ensuring material is made in a safe and compliant manner and meeting company targets. This individual is directly responsible for the teams whose goals are to produce products on the manufacturing floor. The Manufacturing Manager is also responsible for the development of staff to accommodate Iovances needs as a growing organization.

Shift: Monday to Friday from 3pm 11:30pm

Essential Functions and Responsibilities

Oversees the Manufacturing Operations team to support startup and clinical production as well as initial plan for commercial material in support of Iovances strategic objectives.
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 nonconformances 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. Expert level in visual management KPIs huddle boards etc. Continuously seek and support new approaches practices and processes to improve the efficiency and effictivity of the operation.
Ensure batchrelated documentation (batch records and SOPs) is closed in a timely manner to support batch release. Since it is a justintime 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.
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
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.
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.

Travel
May require travel based on business needs

Required Education Skills and Knowledge

Minimum B.S. degree in biology biochemistry bioengineering or related technical field or equivalent industry experience.
Minimum 3 years of experience in biopharmaceuticalbased GMP and management experience manufacturing operations including experience in cell culture and associated downstream processing.
Demonstrated technical knowledge of aseptic processing in cleanroom environments a must.
Solid knowledge of FDA regulations and GMP systems.
Solid knowledge of human error reduction strategies rightfirst time and just culture.
Demonstrated project management skills. Excellent oral and written communication skills. Strong technical writing ability.
Experience leading development initiatives i.e. training coaching learning initiatives.
Ability to motivate and mentor peers and staff as well as foster a culture of continuous improvement and operational excellence.
Proactive results oriented selfstarter with demonstrated strong leadership skills and experience in a complex manufacturing environment. Selfmotivated and willing to accept temporary responsibilities outside of initial job description.
Must be comfortable in a fastpaced 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.
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 (potentially 50 employees) representing a variety of personalities and experience levels.

Preferred Education Skills and Knowledge

As this person will be the responsible for oversight of the autologous cell therapy manufacturing program a background in cell culture aseptic gowning and qualification and ISO class 5 cleanroom operations is required. Cell/gene therapy experience.
Minimum of 510 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture and associated downstream processing.
Minimum of 3 years in a Lead/Leadership/Supervisory Role.
Quality mindset familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
Proactive results oriented selfstarter with experience in a complex manufacturing environment.

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.

For the Visual Inspection Program the technician must be able to pass a Vision Exam that includes the following:

Must not be color blind
Must have 20/20 near vision in both eyes (can be corrected)

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 halfface 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 problemsolving analysis and discretion; ability to handle workrelated 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 equalopportunity employer our employees and applicants will be considered without regard to an individuals 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 .

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