- 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
- 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
Bachelor's (required) in Life Sciences (preferred), 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
This person is responsible for supporting clinical packaging manufacturing operations inside and outside the northern California 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.
Through your experience and knowledge you 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.
This role partners with other Company supply chain members to ensure packaged material is available for clinical distribution. The Manager, Clinical Packaging Operations will participate in improvement efforts and is an integral member of the product launch team.
This is a cross-functional role in 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.