Provide technical support for the qualification of the PET CMOs and relevant PMFs within a growing network and portfolio of products. Provide technical expertise within the function to support the cross-functional project team and field execution support to ensure manufacturing facility, processes and support systems are in compliance with company validation guidelines, NDA and cGMP regulations for PET facilities and their suppliers. Develop lifecycle management program to ensure on-going management of PET CMO network. Provide technical support for the evaluation of new products, clinical manufacturing and supply.
- Represents Technical Operations for clinical and commercial projects with Quality, Regulatory and R&D, assessing adequacy of manufacturing process according to clinical phases, providing technical insight to risk assessments for new products, and authors/reviews technology transfer plans at PET CMO sites to assess if appropriate for the product & process. Interfaces with clinical suppliers for new processes, quality issues and process improvements for assigned projects.
- Provides support for inspection readiness, participates in regulatory agency inspections and provide audit support, as required.
- Maintains technical oversight of PET CMOs sites to ensure regulatory, procedural, standards and contractual compliance. Includes: supporting technical visits to PET sites including technical audits; support of investigations, root cause analysis and generation of CAPA; assessment of manufacturing process changes to ensure that quality attributes are maintained; author Annual Product Reviews; and drives continuous improvement projects relating to Product Quality.
- Ensures an uninterrupted commercial supply of lead product. This work includes review of the batches on a continuous basis to identify any negative manufacturing trends and to correct them; overseeing compliance with the instruments' maintenance program and continuous personnel training; in collaboration with Supply Chain, facilitating maintenance of an adequate consumables inventory at PMFs; and, finally, in collaboration with Vendor and CMO, troubleshoot potential batch failures and resume production in a shortest possible time.
- Provides technical expertise to weekly/monthly/quarterly PET CMO and Supplier Review meetings. Works with partner groups to develop and present metrics relating to PET CMOs and suppliers.
- Represents Technical Operations with Quality, Regulatory, Commercial, R&D, and Supply Chain for PET manufacturing, and builds strong working relationships to contribute to a high-performance culture. Collaborates well with the cross-functional team and work efficiently in a team environment. Communicates effectively with management, and vendors.
- Actively demonstrates the Lantheus values of accountability, collaboration, customer service, quality, efficiency and safety.
Experience and Education Requirements
- Bachelor’s or Master’s degree in science or engineering with > 8 years of experience in pharmaceutical or biopharmaceutical industry, including GMP; or PhD in science or engineering with >3 years of experience in pharmaceutical or biopharmaceutical industry, including GMP. Analytical background is preferred. Prior experience with radio-pharmaceuticals and, in particular, with PET imaging agents is desired.
- Demonstrated leadership and managerial skills. Oversees team of internal scientists and engineers; manages external vendors to ensure compliance to project timelines, cGMPs and on-going manufacturing operations.
- Exceptional knowledge of scientific field of specialization.
- Ability to recommend, judge, and make good decisions in complex situations.
- Strong organizational, presentation and communication skills, both written and verbal.
- Demonstrated ability to effectively write technical documents, including test plans, protocols and reports.
- Travel (including international, overnight, and weekend) may be required, approximately 10-20%