MANUFACTURING OPERATIONS MANAGER (US)

SCOPE OF POSITION

WE ARE ZIONEXA.
Zionexa is a dynamic and growing international company developing and commercializing molecular imaging companion diagnostics (CDx’s) for targeted therapies in Oncology that will help clinicians find the right treatment for the right patient at the right time. Our goal is to improve patients’ pathways and overall quality of life.

 

We are looking for a Manufacturing Operations Manager, to be based out of the New York City area who will be responsible for managing the U.S. manufacturing operations for this exciting company. The position will provide daily oversight of Contract Manufacturer(s) (CMOs) of our products.

Responsibilities will include:
  • Lead the team in the qualification, set-up and start-up of the company’s vendor manufacturing sites throughout the U.S., with the support of internal resources.
  • Assist with the development and implementation of new site related operations, policies and procedures.
  • Coordinating continuous improvement to ensure operational excellence as well as corrective action plans, together with key company stakeholders including QA, Industrial Development, Sales, CMC and CMOs
  • Work with CMO’s leadership to ensure operational goals are met, consistent with the company’s QA and Regulatory requirements.
  • Provide outstanding customer service and support to both internal and external customers in an environment requiring daily and just in time manufacturing and distribution of products for same day use.
  • Have responsibility for inventories relating to all of the CMOs’ sites and their operations.
  • Responsible for operational budgetary compliance. Participate in the budget preparation and be responsible for ongoing monitoring of the Operations budget.
  • Work with Senior Management, Quality and Regulatory, the FDA, Nuclear, Regulatory, State and other governing bodies to ensure all sites are consistently in compliance.
  • Prepare and maintain required reports, data and logs.
The successful candidate will have:
  • A bachelor’s degree in Engineering, Industrial Engineering, Chemistry, PharmD, Bio-Engineering, Biology or a related field. Related advanced degree would be great.
  • Related and progressive experience in manufacturing, operations in a manufacturing and/or production in pharma and/or life sciences environment, with preference to radio-pharmacy and/or radioisotope areas.
  • Prior experience working with external vendors and multi-site manufacturing and distribution operations.
  • Prior managerial experience.
  • Excellent project, time management and team building skills.
  • Prior experience working with regulatory, federal, state and local agencies.
  • Excellent communication, organization, analytical, presentation and computer/pc skills including Microsoft Office 365 and project planning software.
  • Domestic travel in excess of 50% is required, along with the ability to travel  internationally.
Compensation:

We offer an attractive compensation and benefits package!

Come be a part of this dynamic team and join us on our exciting journey.
For immediate consideration, please submit your resume/cv to: hr@zionexa.com

 

 

Zionexa is an EEO/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.