DESCRIPTION

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! 

POSITION PURPOSE 

PDI is seeking a Sr Analytical R&D Manager to 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. 

ESSENTIAL FUNCTIONS AND BASIC DUTIES 

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

QUALIFICATIONS

EDUCATION / CERTIFICATION

Advanced Degree in Chemistry Regulated background in either FDA or EPA environment

REQUIRED KNOWLEDGE

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.

EXPERIENCE REQUIRED

10+ years of R&D working experience Laboratory Management Team Management Resource/project Planning Previous experience within the Healthcare field advantageous.

SKILLS / ABILITIES

Demonstrated ability to lead others. Excellent communication skills (verbal / written / presentation). Highly motivated to work as a member of a nimble team. Embraces change and risk and exhibits flexibility. Exhibits excellent organization, planning and multi-tasking skills; able to handle multiple projects/tasks at the same time. Able to influence cross-functional partners to gain support and alignment to ideas. Steadfast under pressure. Computer literate (MS 365, Empower, Electronic Notebook, LIMS).

WORKING CONDITIONS

About 10% Lab and 90% office environment

SALARY RANGE

$130,000 - $150,000 Annually

BENEFITS 

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

Medical, behavioral & prescription drug coverage Health Savings Account (HSA) Dental Vision 401(k) savings plan with company match and profit sharing Basic and supplemental Life and AD&D insurance Flexible Spending Accounts (FSAs) Short & long-term disability Employee Assistance Program (EAP) Health Advocacy Program

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts. 

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including:  sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.