The Senior Manager, External R&D and Technical Services is responsible to provide strategic R&D direction with a special focus on Third Party generic R&D projects, 505b(2) projects , Injectables, technical transfer of development and marketed products and R&D Due Diligence. This is a key role with a wide responsibility to assist in portfolio selection, due diligence activities, oversee external development, continuity of supply and serve on project teams. Focus of this role is on both Solid and non-Solid Oral dosage forms such as injectables, ointments, creams etc.
This US-based role reports to Senior Director, External R&D and Technical Services and is based in Pine Brook, NJ.
Primary responsibilities of this role include the following:
- Provide strategic and tactical direction for the development of parenteral, semi-solid, transdermal systems and other complex drug delivery systems.
- Assist Business Development and Portfolio Management in assessing new opportunities for internal development, co-development, 505b(2) products, licensing, and acquisitions.
- Conducts scientific literature search, evaluates, develops, and recommends new platform technologies, Suggests patentable, patent non-infringing and design around technologies for FTF products.
- Performs Due Diligence for new product pipeline and feasibility analysis for external development.
- Design experimental plans or oversee them, and ensure routine development and scale-ups, including trouble shooting.
- Oversee Product Development Reports, process development reports and other relevant documents as required for filing.
- Manage technical transfers of development and marketed products.
- Troubleshoot and/or support commercial manufacturing in resolving OOS, deviations and investigations.
- Understands timelines and demonstrates a sense of urgency in work and in responding to customers and colleagues.
- Is motivated to do what is expected, be a self-starter. Makes things happen
- Quality Oriented: Never compromise quality in efforts to deliver products to our customers and partners
- An advanced degree in a Science or a related field. Master’s degree with eight (8) or more years or PhD degree with six (6) or more years of experience in a pharmaceutical generics R & D setting.
- Experience in developing and scaling up parenterals, semi-solid, transdermal systems and other complex drug delivery systems.
- Up to date information and knowledge of FDA Regulatory requirements, cGMP and SOPs related to pharmaceutical product development, manufacturing and documentation
- Proven ability to be an effective hands-on leader.
- Must have excellent organizational, verbal communication and technical documentation skills.
- Ability to travel as needed.
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