Senior R&D Manager

Title: Senior R&D ManagerMake sure to read the full description below, and please apply immediately if you are confident you meet all the requirements. Location: Woodcliff Lake, NJ (hybrid) Schedule: M-F 8 AM- 4 PM/9 AM- 5 PM Type: Direct Hire Responsibilities: Lead and provide effective guidance for a team with a focus on developing products in the drug (OTC, DIN, NHP), medical device, cosmetic, disinfectants (EPA, DIN) and general household products areas. The Manager will direct method development, method validation, method transfers, routine stability testing, and investigational testing for chromatographic, spectroscopic, and potentiometric/colorimetric titration methods. The Manager oversees the work within their group and external service providers to ensure that the goals of the project teams are met in a timely, cost-sensitive, and phase-appropriate fashion. The incumbent is responsible to align analytical development activities with project teams, regulatory development strategies and timelines and build the technical capabilities and collaborative scientific and operational partnerships needed to effectively carry out the department mission in a R&D/GMP/GLP compliant quality standard as warranted. Efficient resource deployment regarding workload, capacity, and resourcing in partnership with key stakeholders. Manage the laboratory in terms of budget for supplies/equipment, improve process workflows, and ensure employee health and safety. Partner with Industry and/or Academia to manage work overflow and investigational studies. Actively seek new partnerships in both technologies and testing support. Author, review, and approve technical protocols and reports for method development, validation, and transfers. Lead and action on items from various quality systems, such as change controls, CAPAs, OOS, etc. as needed. Oversee internal and external Stability Program. Lead small cross-functional project teams in various workstreams related to analytical methods and technology. Develop and grow a dedicated group of scientists. Manage performance metrics. Ability to assess individual performance and behaviors against PDI's core values. Cross functional communication across Quality Control, Quality, Regulatory and Product Development. Education: Advanced Degree in Chemistry Requirements: Regulated background in either FDA or EPA environment (Health Care/Medical Device) Rich Chemistry knowledge and understanding of chemical properties, interactions, and methods of analysis. In-depth technical knowledge of a variety of analytical techniques, including LC, GC, MS, NIR, FTIR, titration, etc. Demonstrated understanding of GDP/GMP/GLP. Strategic thinking in a competitive landscape. 10+ years of R&D working experience Laboratory Management and Team Management Resource/project Planning Previous experience within the Healthcare field advantageous. Computer literate (MS 365, Empower, Electronic Notebook, LIMS) 1-2 years people management for Manager level OR at least 5 years of people management for senior level Manage a group of 10 people on the team (Sr Scientists, Principle Scientists and Group Leads) Read and understand protocols and reports for method validation. Text book technical knowledge over hands on experience is okay. FDA experience - Part of the ICPC strategic sub group. Managing the FDA workstream. Assessing third party labs and managing those relationships

Created: 2025-02-28