Job Information
Nice Pak Scientist II - Formulations in Woodcliff Lake, New Jersey
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
The purpose of the Scientist II role is to advance the development and formulation of products within the Interventional and Patient Care segments, focusing on FDA OTC, Medical Device, and Drug regulated products. This position is essential in conducting high-level research, developing innovative methodologies, and supporting all phases of product development to ensure compliance with stringent regulatory standards. The Scientist II will collaborate across departments, mentor junior staff, and influence cross-functional teams to drive the successful progression of projects. By leveraging their expertise in formulation, product development, and regulatory requirements, the Scientist II will contribute to the creation of safe, effective, and competitive products that meet market needs and compliance demands. This role is pivotal in fostering a culture of continuous improvement, strategic thinking, and operational excellence within the organization.
Job Summary:
The Scientist II plays a critical role in conducting research, developing methodologies, and supporting product development in a regulated environment. This role is specifically focused on Interventional and Patient Care formula development as it relates to FDA OTC, Medical Device, and Drug regulated products. The Scientist II is responsible for executing complex experiments, analyzing data, maintaining compliance with regulatory standards, and contributing to the overall success of research initiatives. This position also involves influencing cross-functional partners, managing laboratory operations, and demonstrating strategic thinking in a competitive landscape.
Job Requirements:
Conduct complex research and experiments to support product development.
Maintain compliance with regulatory standards and quality procedures.
Mentor and collaborate with team members on various projects.
Prepare technical reports, SOPs, and regulatory submissions.
Communicate effectively with internal and external stakeholders.
Manage multiple projects and priorities to meet deadlines.
Implement continuous improvement initiatives in research processes.
Influence cross-functional partners to gain support and alignment to ideas.
Demonstrate steadfastness under pressure.
Exhibit strong computer literacy.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
Research Initiative & Development:
Conduct research to develop methodologies and procedures for new drug and medical device products.
Assist and support the design, preparation, and execution of pre-clinical and clinical research studies.
Prepare technical reports, scientific publications and reviews, and presentations.
Demonstrate a strong understanding of chemistry and Good Laboratory Practices.
Formulation and Regulatory Support:
Batch lab-scale formulations and support stability studies.
Assist in product scale-up, line trials, and regulatory submissions.
Provide guidance and support to QC and regulatory functions.
Develop and maintain products in an FDA-compliant manner, including OTC, Medical Device, and Drug products.
Support new and existing FDA product development with input across all facets of project progression, including registration testing to meet regulatory requirements.
Product Testing and Analysis:
Calibrate instrumentation, help troubleshoot equipment, and maintain laboratory supplies.
Assist in the development of test methods, SOPs, and technical documentation.
Test products and prototypes, comparing them to benchmarks or competitor products.
Analyze data, prepare technical reports, and contribute to trial report generation.
Develop and validate test methods for product evaluation.
Analyze competitor products and raw materials.
PERFORMANCE MEASUREMENTS
Mentor junior scientists and technicians in analytical techniques and safety practices.
Calibrate instrumentation, troubleshoot equipment, and maintain laboratory supplies.
Assist in the development of test methods, SOPs, and technical documentation.
Manage multiple project objectives efficiently and adapt to changing priorities.
Demonstrate a willingness to develop formulation skills and take on more responsibilities.
Communicate effectively and cooperate with team members and cross-functional teams.
Demonstrate strategic thinking in a competitive landscape.
Progress projects actively through the PDI pipeline, ensuring technical operations and effective collaboration.
QUALIFICATIONS
EDUCATION/CERTIFICATION:
Bachelors Degree in Chemistry (or related field).
Regulated background in FDA – OTC, Medical Device, and Drug development.
REQUIRED KNOWLEDGE:
Previous experience in an R&D lab.
Familiarity with regulatory guidelines and laboratory procedures.
Strong understanding of chemistry and Good Laboratory Practices.
EXPERIENCE REQUIRED:
2 to 5 years of R&D laboratory experience.
Hands-on experience with formulation, product testing, and analytical techniques.
SKILLS/ABILITIES:
Ability to influence cross-functional partners and gain support and alignment to ideas.
Strong laboratory management skills.
Experience in developing products in the FDA OTC, Medical Device, and Drug segments.
Ability to leverage research and development skills inclusive of scientific insights, formulation development, product registration, processing, and manufacturing.
Support excellence in the new product development process, including registration testing to meet regulatory requirements.
Effective communication skills to actively progress projects through the PDI pipeline.
WORKING CONDITIONS
- 70% Lab / 30% Office
SALARY RANGE
- $60,000 - $80,000 annually
PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes:
Medical & prescription drug coverage
Dental / Vision plan
401(k) savings plan with company match
Basic and supplemental life insurance
Flexible Spending Accounts (FSAs)
Short- and long-term disability benefits
Health Advocacy Program / Employee Assistance Program (EAP)
Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance
At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options
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)
