Our client is looking to fill the role of Product Development Formulator. This position will be on site 5 days a week in the West Caldwell, NJ office.
Responsibilities:
- Will be responsible for research of patents and literature for documentation support for current projects.
- Responsible for conducting experiments and trials to develop finished products FDA filings (NDAs and ANDAs).
- Will be performing formulation work in the QC and R&D laboratory.
- Experience authoring submission documents such as Product Development Reports and Quality Operations Summaries.
- Will be responsible for the evaluation of raw materials to be used in formulation projects.
- Create tentative raw material, in process, finished product and stability specifications.
Required Qualifications:
- Bachelor’s degree in a scientific discipline (Chemistry preferred).
- 2+ years of experience in prescription liquid formulations is required.
- Experience working in an FDA regulated environment.
- Possess technical knowledge of liquid product development procedures and material capability studies.
- Working knowledge of USP Monograph testing, method development & validation.
- Strong knowledge of scientific principles and practices in an FDA regulated quality control laboratory.
- Knowledge to perform patent research and literature research as appropriate.
- cGMP process knowledge and lab safety procedural knowledge.
- CFR & ICH Regulatory guideline knowledge
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
