Senior R&D Manager

3 days ago

Montvale NJ United States Joulé Full time

Title: Senior R&D Manager

Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks.
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.

PERFORMANCE MEASUREMENTS Demonstrate year on year increase in productivity.
Effective communication and cooperation with other team members.
Elevation of the Analytical team among the R&D community and business as a whole.
Ensure implementation of robust processes and procedures that maintain compliance to all applicable GxP regulations, Company and Department procedures/policies
Recruit, develop and retain an effective technical team; act as a model for the R&D organization.
Develop the team by providing guidance on career development, monitoring competency improvements, and finding opportunities for continuing education
Effectively manage budget for Analytical R&D cost center

Requirements: Advanced Degree in Chemistry
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
Team Management
Resource/project Planning
Previous experience within the Healthcare field advantageous.
Demonstrated ability to lead others.
Computer literate (MS 365, Empower, Electronic Notebook, LIMS)
Some technical knowledge is very helpful but people management is more important.
1-2 years people management for Manager level OR at least 5 years of people management for senior level
10 people on the team (Sr Scientists, Principle Scientists and Group Leads)
Managing Group Leads who are being groomed to be Managers
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
Working closely with other Managers and communicate cross-functionally at all levels

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