Manager, Manufacturing Operations - Philadelphia, United States - Iovance Biotherapeutics Inc

Iovance Biotherapeutics Inc

Verified Company

Philadelphia, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

Iovance is hosting an onsite Job Fair.

Where:
_Iovance Cell Therapy Center (iCTC)_

Location:
_300 Rouse Blvd Philadelphia, PA 19112_

Date:
_ Monday, June 24, 2024_

Time:
_12pm to 6pm (EDT)_

What to bring:
U_pdated resume_

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

In this postion, 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 Iovance's needs as a growing organization.

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 Iovance's 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.
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 execution, 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 mínimal 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 en