Associate/Manager, MSAT and External Manufacturing

Location
Tampa, FL
Posted
Nov 09, 2018
Required Education
Bachelors Degree
Position Type
Full time

Associate/Manager, MSAT and External Manufacturing

Manufacturing – Tampa, Florida

The Associate or Manager,  MSAT and External Manufacturing will be a Technical Operations cell therapy expert that will actively collaborate with quality, regulatory, manufacturing, process development teams, and our Contract Manufacturing Organizations (CMO), in the US and Europe. The position is responsible for assisting with and/or coordinating the transfer and implementation of projects, processes, and technology from process development to CMO sites for Iovance’s cell therapy products.

This position is also responsible for the technology transfer of new or modified processes to ensure robust and reliable manufacturing processes for Clinical and Commercial scale. This position will assist in the planning, coordinating, and overseeing of the technology transfer product life cycle which includes development, stability, product validation batches, cleaning validation/verification studies, data monitoring, and non-conformance investigational support.

Responsibilities

  • Participate on cross functional teams to drive complex change controls and new process introductions.
  • Utilize technical writing strategies to ensure change control content is clear, concise, and complete. Ensures timely progression of change controls through the various phases of the process.
  • Assist integrating process transfers into the existing Manufacturing structure, including SOPs, batch records, work instructions, and training curricula. 
  • Ensure operational readiness for process transfers and change controls, including; the facility, equipment, documentation, and staff.
  • Initiate, revise, and approve manufacturing procedures. Ensures all procedures reflect current operations. Serve as a document reviewer, owner, and approver as appropriate.
  • Prepare and participate in regulatory inspections.
  • Utilize strong operational excellence / lean principles, business acumen, quality-mindedness, and exceptional communication skills to develop streamlined, efficient, and robust systems, and to affect positive change.
  • Develop manufacturing strategies for resolving complex issues related to new process transfers to CMOs product.
  • Write risk assessments, protocols, manufacturing batch records, and supporting documentation for regulatory submissions.

Required Experience

  • Bachelors in relevant discipline or equivalent in work experience.
  • 0-2 years of experience for Associate
  • 3+ years for Manager
  • Must possess an understanding of cell therapy manufacturing
  • Must be able to translate bio-tech processing into documentation such as batch records and SOPs
  • Ability to work independently to meet objectives and perform with a high degree of accuracy.
  • Exhibits leadership behaviors including collaborating for results, and developing/executing strategy.
  • Creates an environment that encourages continuous improvement, best practices and appropriate risk taking.
  • Ability to prepare high quality presentations and speak, present data, and defend approaches in front of audiences, including management or inspectors.
  • Technical writing must be at an advanced level with proficient spelling, grammar, and typing skills. Ability to understand and teach special writing skills and minimizing risk of language.
  • Ability to perform gowning activities and enter the manufacturing plant.
  • Must possess strong verbal and written communication skills.
  • Must have experience working in various Quality Systems, understanding of facility technology, system troubleshooting, CAPA's and change controls.
  • Project Management experience with prior experience managing multiple assignments and processes while developing practical and thorough solutions for complex issues.
  • Strong ability to influence in a team environment and collaborate with peers
  • Expert in Microsoft Office programs.