Senior Packaging Operations Specialist - United States
- Our company 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.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’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 our company’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.
- The Packaging Operations Sr. Specialist/Manager is responsible for supporting clinical packaging manufacturing operations inside and outside the facility.
- S/he will help coordinate clinical material needs between contract manufacturers and the internal project teams to ensure that all clinical product needs are defined and met.
- The Packaging Operations Sr. Specialist/Manager will evaluate upcoming packaging requirements, provide a single point of contact for Contract Manufacturing sites, communicate project details and ensure that all key milestones are met. S/he is the SME for all things involving Production-related activities for selected clinical products. This role partners with other company supply chain members to ensure packaged material is available for clinical distribution.
- The Packaging Operations Sr. Specialist/Manager will participate in improvement efforts and is an integral member of the product launch team.
- The Packaging Operations Sr. Specialist/Manager is a cross-functional role which S/he will work closely with Clinical Operations, Development Sciences, Regulatory and external vendors to ensure all clinical labeling/packaging operations are met or exceed timelines. The individual will often work under very tight timelines.
- Initiate and manage label clinical label text following country regulatory guidance.
- Manage packaging and label changes in existing clinical products within study timelines.
- Communicate forecast, detail and communicate routine work items, coordinate internal resources to accomplish project goals
- Facilitate issue resolution and problem solving with contract manufacturers
- Monitor production efforts at contract manufacturers
- Lead weekly meetings with CMOs and capture discussions in minutes
- Communicate with members of the manufacturing group and other departments to optimize the production schedule. Promptly elevate issues to upper management that compromise on-time drug availability
- Complete tasks within the Oracle ERP system as related to production.
- Initiate Change Control, Deviations, and CAPAs through the Trackwise system.
- Communicate in online meetings with Europe and Asia, which requires availability outside of standard working hours.
- Support Manager to develop budget.
- Proactively identify risks. Create strategies to avoid or minimize their impact. Manage the execution of risk mitigation plans.
- Provide back-up support for other Operations Specialist(s) and/or Coordinator(s)
- Other duties as assigned
- Bachelors in Life Sciences, Business, or Engineering with minimum 5-8 years experience in the pharmaceutical field and/or clinical packaging/labeling
- Clinical Packaging and project management experience is highly desired
- Demonstrated project management skills related to all aspects of clinical packaging/labeling activities
- Proven track record to successful meet on-time delivery of clinical packaging/labeling projects
- Collaboration/Influence Management, Decision Making, Results Orientation
- Ability to work effectively with cross-functional and multi-location teams
- Successful track record in execution of deliverables. Changes in plans and updates are proactively communicated to management and teams
- Strong quality orientation with attention to detail
- Working knowledge of current GMP/GCP regulations desired.
- Working knowledge of manufacturing processes
- Proficient in MS Office, MS Project, and Visio
- Excellent organizational, interpersonal communication, and problem-solving skills
- Ability to find, communicate, and implement ways to continuously improve processes
- Proficiency with Oracle or other materials management systems knowledge desired
- Strong organizational and leadership skills.
- Process development or technology transfer experience preferred.
- Excellent written, verbal, and presentation communication skills.
- Negotiation skills
- Networking skills