Qualifications

• Bachelors degree required
• Minimum of ten years of progressive experience in Operations Management and Prior supply and budget planning experience required
• Strong knowledge and understanding of cGMPs and applicable regulatory requirements as required
• Full working knowledge of Operations / Supply Chain Management
• Must be proficient in MS Office Suite
• Strong proficiency in Microsoft Dynamics NAV required
• Certificates, Licensed, Registrations: None required
• Excellent written and verbal communication skills, including presentation skills
• Ability to prioritize and multi-task successfully in a fast paced environment
• Ability to work autonomously, as well as act as a strong team player
• Excellent time management skills and a proven ability to work on multiple projects at any given time
• Demonstrated leadership and project management skills
• Ability to communicate across all levels of the organization
• Demonstrated ability to stay abreast of trends and new information in the profession
• Ability to anticipate and evaluate risks and develop contingency plans to ensure continuous supply of Commercial Drug Product and APIs
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily

Responsibilities

• The Director - Supply Chain is responsible for ensuring the continuous supply of commercial Drug Product while striving to keep manufacturing, storage, transportation and waste costs at a minimum
• This individual manages the overall process for processing, transportation and storage of commercial products
• The Director - Supply Chain is responsible for implementing all changes associated with packaging and labeling commercial drug product according to FDA regulations
• This individual manages communications, logistics and transportation activities for all Clients commercial products and late stage development products
• Other duties may be assigned
• Manages a cross functional team which includes participants both within and outside of the company including IT, Finance, QA, PM, Tech Ops, Commercial, Legal, Serialization Software manufacturers and Commercial packagers to ensure that serialization is successfully implemented across the entire Client commercial product line
• Creates serialization Test Scripts for validation of serialization software
• Collaborates on the packaging vendors on the validation of both software and hardware supporting serialization activities
• Works with colleagues in Technical Operations and Quality Assurance to source Active Pharmaceutical Ingredients (APIs), excipients and other components required for late stage development projects
• Works with colleagues in Technical Operations and Finance to plan long term inventory strategies for Drug Products, APIs, excipients and components
• Meets regularly with Commercial Sales Operations to obtain drug product forecasts (commercial sales, patient assistance and physician samples)
• Converts Commercial Sales Operations forecasts into manufacturing/packaging forecasts which are provided monthly and annually to co-partners and vendors according to supply contacts
• Plans and maintains inventory levels following Clients long term inventory and distribution strategies for each commercial product
• Generates purchase orders to vendors in accordance with contractual obligations and lead times to ensure on-time product delivery to Clients distribution facilities
• Coordinates all logistics for commercial, sample, and PAP (Patient Assistance Programs) drug product
• Coordinates all commercial supply activities with s partners
• Joint Manufacturing Committee member for all commercial partnerships
• Establishes and maintains inventory stocking levels for commercial sampling programs
• Meets regularly with manufacturing and packaging vendors to communicate information, resolve outstanding issues, coordinate activities and plan future production
• Administers and manages the inventory database/supply chain software and trains new users
• Facilitates drug product and API release from US Customs and FDA holds when necessary
• Manages Clients inventory of APIs and other necessary components, plans the manufacturing and delivery of these items based on the long term forecasts and stability
• Coordinates and facilitates supply related activities during commercial recalls
• Prepares qualification / audit request forms for all potential service providers
• Participates in quality audits of distribution and transportation suppliers
• Maintains bills of materials for all Client packaging configurations
• Manages Clients sample retention program
• Prepares the 10Q manufacturing commitment report for Finance
• Coordinates and facilitates the reporting of insurance values of preclinical, clinical and commercial inventories
• Works closely with Finance, Commercial Sales Operations and QA to investigate any inventory discrepancies at Clients distribution facilities and Specialty Pharmacies
• Works with Regulatory Affairs to implement commercial packaging labeling changes