OPERATIONS MANAGER (US)
SCOPE OF POSITION
WE ARE ZIONEXA.
ZIONEXA IS A YOUNG, DYNAMIC INTERNATIONAL COMPANY DEVELOPING AND COMMERCIALIZING MOLECULAR IMAGING COMPANION DIAGNOSTICS (CDX) 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 an Operations Manager who will be responsible for managing the U. S. manufacturing operations, providing daily oversight of contract manufacturer(s) (CMOs) of our products. The position will coordinate continuous improvement as well as corrective action plans, together with key company stakeholders including QA, Industrial Development, CMC and CMOs.
The position will:
- Lead 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.
- Work with CMO’s leadership to ensure operational goals are met, consistent with the company’s QA and Regulatory requirements.
- Coordinate continuous improvement to ensure operational excellence as well as implementation of corrective action plans, together with Zionexa stakeholders.
- Provide outstanding customer service and support to both internal and external customers in an environment requiring daily and jut 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.
- Have responsibility for budgetary and financial matters ensuring that Operations are performing within budget. They will also participate in the budget preparation and be responsible for ongoing monitoring of the Operations budget.
- Work with Senior Management, the FDA, Nuclear, Regulatory, Quality, State and other governing bodies to ensure all sites are consistently in compliance.
- Prepare and maintain required reports, data and logs.
- Assist with related projects as needed.
The successful candidate will have:
- A bachelor’s degree in Engineering, Industrial Engineering, Chemistry, Biology or a related field.
- Related and progressive experience in manufacturing, operations and/or production with preference to radio-pharmacy, radioisotope, pharmacy or life sciences..
- Prior experience working with external vendors and multi-site manufacturing and distribution operations.
- Prior managerial experience.
- Excellent communication, organization, analytical, presentation and computer/pc skills including Microsoft Office 365 and project planning software.
- Excellent project and time management skills.
- Prior experience working with regulatory, federal, state and local agencies would be a plus.
- Able to travel extensively in the U.S (50% +). Some international travel will also be required.
We offer an attractive compensation and benefits package including health, life, dental and 401K with employer match.
Come be a part of this exciting journey. For immediate consideration, please submit your resume/cv to: email@example.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.