Immunomedics, Inc.

Senior Director, CMO Management

Job Locations US-NJ-Morris Plains
Posted Date 4 months ago(2/5/2020 4:20 PM)
Job ID
2020-1634
# of Openings
1
Category
External Management

Overview

Reporting to the Vice President, External Manufacturing, develop and Implement the lifecycle of contract manufacturing strategy for commercial or clinical products at one or more monoclonal antibody third party manufacturing organizations (CMO).  Activities include CMO selection, process technology transfer, CMO management, and routine cGMP manufacturing monitoring and management.  Establish and maintain alignment between CMO site business, operations and quality objectives and plans and Immunomedics commercial/clinical manufacturing strategies and plans. Establish and manage business operations, and quality relationships and communications between Immunomedics and the CMO as the lead point of contact for Immunomedics. Build and lead cross functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operations and quality objectives, plans and performance goals. Provide the single point of accountability for identifying and managing timely resolutions of business, operational and quality issues through established CMO site governance structure. Provide strategy planning for scaleup and second source activities across the whole global supply chain. Build and Manage team of Persons in Plant to cover global supply chain.

Responsibilities

  • Provides insight for site selections, key player in tech transfer and oversees Immunomedics and CMO activities for third party manufacturing
  • Provides production process troubleshooting including travel to CMOs to monitor production: interfaces with CMOs and internal departments to facilitate manufacture and release of product
  • Coordinates and executes activities related to technology transfers, validation and process improvements as manufacturing partners.
  • Immunomedics CMO site lead for operations
  • Coordinate product and material shipments to and from Immunomedics and CMOs
  • Compile and report on CMO performance and monitor improvement plans
  • Support Site Quality Manager to ensure CMO complies with Quality Agreement
  • Assist in development of the CMC sections of Regulatory filings which include areas for inclusion of CMO process and information
  • Develop, monitor, manage and report on budget for CMO operations
  • Develop and manage, train and mentor team of Persons in plant for global manufacturing coverage
  • Establish long term strategy for second sourcing, scale up and current manufacturing for future growth of the products and company stability

Qualifications

  • BS/ PhD in Chemistry, Sciences or equivalent with 15+ years related experience within a pharmaceutical or Biotechnology Company.
  • Additional technical experience in an area allied with cGMP Quality, Phased approach to Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines
  • Strong understanding of pharmaceutical manufacturing processes for antibody drug conjugates, or small molecules
  • Experience in technology transfers of complex manufacturing processes
  • Excellent verbal and written communication skills, organizational and time management skills; strong attention to detail
  • Based on East coast at Immunomedics in New Jersey
  • Excellent knowledge of GMP, and ICH guidelines as related to drug development process
  • Experience in biologics large molecule manufacturing, for clinical and commercial products
  • Experience with process validation and related regulatory requirements. 
  • Experience in process development and technology transfer of complex processes
  • Demonstrated ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Ability to manage more than one project at a time
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. 
  • Proficiency with Microsoft Office.
  • Excellent verbal and written communication and skills.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

 

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed