PharMEDium Services, LLC, an AmerisourceBergen Company, is a growing outsource compounding organization servicing hospitals nationwide.
The Director of R&D is responsible for development, implementation and technical management of the R&D function for all new and existing service offerings. RESPONSIBILITIES:
- Direct and ensure scientific validity / chemical integrity of all Admixtures.
- Support corporate growth through defining and directing all testing and investigation necessary for future admixtures program expansions and line extensions.
- Scientific interface during FDA, BOPs and other Regulatory agency and Internal Audits.
- Supplier Management of third party contract laboratories through multi level contracts, expenditure tracking and contract resolution, this includes managing annual supplier audits.
- Direct operations for PharMEDium's internal EPA laboratories.
- Determine appropriate testing equipment, personnel structure and deployment of resources in support of PharMEDium's laboratory testing approach to maintain compliance with federal and state standards.
- Direct the development and implementation of new preparation testing methodologies.
- Manage subject expert consultants through contractual agreements, direct oversight of activities and invoice management.
- Define and direct policy for the future state of testing.
- Support internal EPA labs through method transfers from external contract laboratories and as technical expert for ongoing analysis and investigational support.
- Manage department budgets including forecasting, monthly and yearly budget reconciliation, and tax credit compilation.
- Support customer complaint investigations through analytical testing and risk analysis of analytical results.
- Manage the Preparation Monitoring Program including interfacing with all facilities and internal and external contract laboratories for sample delivery, testing and out of limits investigations.
- Manage and Mentor R&D Project Managers and Laboratory personnel.
- Train internal sales representatives on the R&D process and key attributes related to service offerings.
- Communication directly with customers as needed.
- Presentations for GPO and Hospital System visits.
- Bachelor's Degree in Science or related field desired.
- Minimum 12 years hands-on experience in Quality or R&D.
- Strong scientific, analytical and problem solving skills.
- Strong judgment with regard to regulatory, product quality and processing impact as it relates to patient safety.
- Ability to provide direction and judgment based one business and scientific rational.
- Knowledgeable about FDA regulated environment, aseptic drug manufacturing and compounded sterile admixtures.
- Outstanding project management skills and attention to detail with regard to process design and implementation.
- Ability to work well under pressure, maintaining control under fire.
- Strong leadership skills; excellent verbal and written communication skills.
- Success working with cross-functional remote teams.