Senior R&D Manager - System One
Park Ridge, NJ
About the Job
Title: Senior R&D Manager
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
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Source : System One