Senior Scientist Analytical Chemistry at PDI in Woodcliff Lake, New Jersey
Posted in Other 30+ days ago.
Job Description:
Description
Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 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 development and continued improvement of Interventional Care drugs and medical devices for projects such as skin antisepsis, device disinfection, and nasal decolonization.
The primary function of this position is to be a group leader and manage our analytical testing strategy, including method developments, validations, revalidations, verifications, and transfers for chromatographic, spectroscopic and potentiometric/colorimetric titration methods. This is a hands-on role, expected to both execute GMP and R&D sample testing and supervise 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, ICH, USP) requirements by HPLC, GC-FID, titration, and UV/Vis spectroscopy.
- Develops a comprehensive test method strategy and impurity characterization plan to support regulatory filings.
- 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.
- Writes test methods, SOPs, validation, stability, and other project reports.
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.
- Calibrates, troubleshoots, and maintains analytical instrumentation and equipment.
FORMULATION AND REGULATORY SUPPORT:
- Leads Analytical expertise for cross-functional project meetings.
- Participates in experimental design setup and tests product prototypes.
- Generates documentation required to support regulatory filings such as stability reports, technical justifications, change controls, etc. and performs statistical data analysis to provide objective evidence and support findings.
- Adheres to strict filing timelines and manages project deadlines.
PERFORMANCE MEASUREMENTS
- Ability to work in partnership with Formulation and Regulatory functions.
- Develop the careers and skillsets of 1-2 direct reports.
- Support work stream timelines and be able to balance priorities according to stakeholder needs.
- Able to communicate and cooperate with other team members and cross function teams effectively.
- Demonstrate ability to add value to the organization through scientific excellence.
- Take ownership for assigned projects and self-lead initiatives.
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. Considered a subject matter expert for chromatography.
- 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.
- Demonstrated ability to develop, validate and transfer methods.
- Specific hands-on experience with both HPLC and GC-FID required.
SKILLS / ABILITIES
- Excellent communication skills (verbal / written). Ability to explain science to management and enact influence across an organization.
- Highly motivated to work as a group leader of a nimble team. Able to maintain flexibility while adhering to strict regulatory guidelines.
- Exhibits excellent organization, planning and multi-tasking skills; able to handle multiple projects/tasks at the same time.
- Computer literate (MS 365, Empower, Electronic Notebook).
WORKING CONDITIONS
About 65% Lab and 35% office environment
50% in R&D: Woodcliff Lake, NJ. 50% in GMP Lab: Orangeburg, NY
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
More jobs in Woodcliff Lake, New Jersey
|
Athleta |
|
BMW of North America |
|
Kiewit |