Senior Manager, Clinical Supply Chain
JOB TITLE: Senior Manager, Clinical Supply Chain
REPORTING RELATIONSHIP: Director, Supply Chain, Planning & Logistics
DATE AVAILABLE: Immediately
LOCATION: Lexington, MA
JOB DESCRIPTION AND RESPONSIBILITIES:
Synageva is seeking a highly motivated individual with strong clinical supply chain experience to be primarily responsible for the hands-on management of clinical supply chain operations.
- Manage clinical label/pack/distribution vendors to ensure sufficient supply for clinical studies.
- Develop new clinical label/pack/distribution contracts, review invoices, and track spend against study budgets.
- Manage clinical supply and operations planning process. Create and monitor IMP demand forecasts based on clinical assumptions.
- Develop production plans for clinical label/pack.
- Proactively identify potential risks and implement mitigation strategies to ensure continuous supply for all studies.
- Interface with IXRS vendor to monitor supply status, update assumptions, and track release of new lots.
- Work with vendors and internal QA to investigate deviations such as temperature excursions and implement appropriate CAPAs.
- Oversee clinical supply metrics and KPIs to drive production efficiency.
- Develop and implement clinical supply chain policies and SOPs.
- Remain current with industry best practices, trends and technologies.
JOB REQUIREMENTS AND QUALIFICATIONS:
- A Bachelor’s Degree in Engineering, Life sciences, Business, or equivalent education or experience is required.
- 6+ years of experience in a pharmaceutical or biotechnology company
- Demonstrated experience with clinical supply chain activities for cold chain biologic products.
- Excellent project management skills; must have high degree of energy, accuracy and attention to detail.
- Outstanding leadership skills and demonstrated passion for creating new medicines, including excellent verbal and written communication skills, an innovative approach to problem-solving, and an integrated view of business and scientific issues.
- Ability to communicate effectively across all levels of the organization from peers and team members to executives.
- Availability to travel up to 20% of the time.