Senior Scientist - R&D Analytical

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

This position is a member of the R&D Analytical team and will work to support all PDI business units in the development and continued improvement of disinfectants, antiseptics and cleaning products in Healthcare and Professional Food Service businesses.

The primary function of this position is to lead test method lifecycle management through method validations, revalidations, verifications, and transfers for chromatographic, spectroscopic and potentiometric/colorimetric titration methods. This is a hands-on role, expected to both execute sample testing and technically mentor junior personnel in the lab. This individual will be responsible to uphold our quality, safety, and efficiency in the laboratory.

Essential Functions And Basic Duties

RESEARCH & DEVELOPMENT:

• Performs GMP and non-GMP analytical testing according to regulatory (FDA, EPA, USP) requirements by HPLC, GC-FID, titration (manual and auto-titration), and NIR spectroscopy.
• Writes and Reviews test methods, SOPs, validation, stability, and other project reports.
• Develops, validates, verifies, and transfers analytical test methods to Quality Control and/or external testing labs.
• Optimizes current methods and innovates to implement efficient technologies to support routine QC release.
• Advances a comprehensive USP Compendial Procedure test method verification plan to support USP methods utilized by Quality Control as part of continuous improvement.

Laboratory Support

• Creates new SOPs where gaps exist. Maintains SOP revisions for continuous improvement initiatives.
• Creates efficiencies in internal R&D analytical processes through optimization of methods, documentation, and laboratory workflows.

Quality Support

• Generates required documentation and performs statistical data analysis to provide objective evidence and support findings.
• Adheres to strict filing timelines and manages project deadlines.
• Prepares technical reports and technical presentations for internal meetings.
• Evaluates test method performance during cross-functional annual product reviews, including trend analysis on system suitability, out of specification results (OOS), and method deviations.
• Participates in and provides technical expertise for cross-functional Investigations, CAPAs, Non-conformances, and change controls.

PERFORMANCE MEASUREMENTS

• Take ownership for assigned projects and self-lead initiatives.
• Support work stream timelines and be able to balance priorities according to stakeholder needs.
• Ability to work in partnership with the Quality and Regulatory functions.
• Demonstrate ability to add value to the organization through scientific excellence.
• Develop the careers and skillsets of 1-2 direct reports.
• Able to communicate and cooperate with other team members and cross function teams effectively.

Qualifications

EDUCATION/CERTIFICATION:

• Bachelors degree in Chemistry
• Ph.D. or advanced degree in Chemistry preferred

Required Knowledge

• Proficient with a variety of analytical instrumentation such as HPLC, GC-FID, and titrations.
• Strong analytical chemistry, method development and validation understanding.
• In depth knowledge of regulated analytical methods.

Experience Required

• 7+ years of R&D or QC working experience in GxP laboratories
• Specific hands-on experience with both HPLC and GC-FID required.
• Demonstrated ability to develop, validate and transfer methods.

Skills/Abilities

• Excellent communication skills (verbal / written). Ability to explain science to management.
• Computer literate (MS 365, Empower, Electronic Notebook).
• Exhibits excellent organization, planning and multi-tasking skills; able to handle multiple projects/tasks at the same time.
• Highly motivated to work as a member of a nimble team. Able to maintain flexibility while adhering to strict regulatory guidelines.

WORKING CONDITIONS

• Able to physically manipulate wet wipe samples by hand through squeezing, wringing, and pushing/pressing motions.
• About 75% Lab and 25% office environment. Willing to regularly travel (20min) between headquarters and GMP facilities. R&D: Woodcliff Lake, NJ. GMP Lab: Orangeburg, NY