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Manager, Packaging Lifecycle Label Change/Launch

Location Novato, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY

The Packaging Lifecycle Label Change/Launch Manager is a full-time member of the Supply Chain planning team with accountability to manage the lifecycle of finished goods packaging component implementation across all commercial products and launches to ensure finished goods products delivered to customers are regulatory compliant.

In this role, you’ll manage one or multiple commercial products label changes/launches and will be responsible for creating targets and ensuring those targets are met. You’ll lead a cross-functional team including team members from Labeling Operations, QA, Packaging Engineering, Regulatory Labeling, and Supply Chain.

This is a unique opportunity to be working with teams responsible for getting the final packaged products (Brineura, Firdapse, Kuvan, Naglazyme, Palynziq, and Vimizim) to patients globally and participate in future product launches. In this role, you’ll be continuously be challenged with competing priorities and will need your excellent communication, people management, leadership, and decision making skills to ensure success.

RESPONSIBILITIES

  • Manage label changes/launches for one or multiple product lines and ensure strict regulatory/commercial targets are met.
  • Develop project plans for launches and critical label changes.
  • Motivate team members; foster and nurture teamwork.
  • Manage Label Implementation Plan (LIP) teams for assigned product(s).
  • Open Trackwise change requests or master change requests.
  • Challenge status quo with continuous improvement and efficiency in mind.

EDUCATION

  • Bachelors in science, Engineering, Business or other fields.
  • Project Management certificate a plus
  • Other continuing education initiatives is highly desirable (e.g. People Management, Leadership) 

EXPERIENCE/SKILLS

  • Minimum 5 years experience in cGMP/GCP compliant Biotechnology, Pharmaceutical, or device operations.
  • Experience in managing projects and leading cross functional teams
  • Excellent oral and written communication skills
  • Creative problem solving
  • Strategic agility and strong attention to detail and execution
  • Experience using MS Project for complex projects


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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