Immunomedics, Inc.

Manager, Contract Manufacturing

US-NJ-Morris Plains
1 month ago
Job ID
2017-1027
# of Openings
1
Category
Scientific Manufacturing/Production

Overview

We are seeking a Manager, Contract Manufacturing to provide technical and operational support for commercial and clinical manufacturing performed at antibody drug conjugates Contract Manufacturing Organizations (CMOs).  He/she will ensure manufacturing operations follow current Good Manufacturing Practice (GMP) and International Conference on Harmonization (ICH) guidelines.  This individual will act as primary contact for all CMO interactions, which includes responsibility for maintaining excellent supplier relationships and timely production schedules.  The position works cross-functionally with internal departments and external resources on Supply Chain-related issues.  The Manager, Contract Manufacturing supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. The position reports to the Executive Director, Manufacturing Supply Chain.

Responsibilities

  • Evaluates external vendors/resources necessary to ensure the successful execution of product supply plans, contributes to the development of Requests for Proposals (RFPs), participates in contract negotiations, and facilitates the execution of legal documents required to engage the vendor’s services.
  • Coordinates activities related to manufacturing, including cytoxin intermediates, antibody, conjugated bulk substance, drug product, packaging, and labeling, ensuring adherence to GMP, Good Clinical Practice (GCP), and ICH guidelines.
  • Provides production process troubleshooting, including travel to CMOs to monitor production of manufacturing activities; interfaces with CMOs and internal departments to facilitate the manufacture, packaging, and release of drug product and intermediates in the supply chain.  Person In Plant (PIP) at CMOs supporting Company.
  • Coordinates and executes activities related to process technology transfer, validation, and process improvements to manufacturing partners.
  • Assists in the identification, development, and implementation of policies, procedures, and standards which impact the department, while working to ensure compliance with applicable regulatory requirements.
  • Assists in the development and maintenance of budgets.
  • Performs other tasks and assignments as needed and specified by management.

Qualifications

  • Bachelor’s degree in a scientific or engineering discipline and a minimum of 6 years of experience in manufacturing (at least 3 of which have been in roles requiring the oversight of outsourced manufacturing) in a pharmaceutical, biotechnology, CMO, or related environment; or the equivalent combination of education and experience.
  • Excellent knowledge of GMP, GCP, and ICH guidelines as related to commercial and clinical manufacturing and the overall drug development process.
  • Demonstrated experience with process validation and related regulatory requirements for biologics.
  • Demonstrated ability to develop project plans for manufacturing transfers, including the ability to manage one or more projects.
  • Ability to influence without direct authority.
  • Proficiency with Microsoft Office.
  • Excellent verbal and written communication skills.
  • Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization, and time management skills, including the ability to support and prioritize multiple, concurrent projects.
  • Cross functional team and project management experience.
  • Experience working with both domestic and international CMOs.
  • Travel requirements – 25-30%; may include international travel

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