Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success.
Our Product Development laboratory located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced PD Scientist.
Product Development (PD) Scientist III designs, plans and conducts pre-formulation, formulation and process development activities as well as scale-up trials with guidance. Plans and executes current Good Manufacturing Practices (cGMPs) pilot and pivotal/submission batches, including all required documentation, under guidance. The incumbent prepares technical reports (including product development reports) and regulatory submission documents and collaborates with Analytical and Project Management to ensure project timelines are successfully met.
· Carries out responsibilities in compliance with all cGMP, Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Occupational Safety and Health Administration (OSHA) regulations, as well as all applicable company compliance guidelines, policies, standards and objectives
• Designs, plans and conducts product development activities, including pre-formulation, formulation, process development and scale up studies with good scientific standards, under the guidance of senior staff
• Supports risk-based and Quality by Design (QbD) related activities during pharmaceutical development
• Performs physical and chemical characterization in liaison with analytical teams
• Plans and executes cGMP pilot and pivotal/submission batches, including protocols, master batch records and reports, under the guidance of senior staff
• Collaborates with Analytical and Project Management to ensure project timelines are met
• Authors regulatory submission documents for New Drug Application(NDA)/Abbreviated New Drug Application (ANDA), supplements, annual reports and Information Requests and Discipline Review Letters (IR/CRL) responses, covering pharmaceutical development and manufacture, including product development reports
• Collaborates with, and assists, Regulatory Affairs with the coordination and submission of Pivotal batches to Clinical Research Organizations (CROs)
• Collaborates with Quality Assurance (QA) on investigations, Corrective Action Preventive Action (CAPAs), and change controls to ensure timely closure
Bachelors degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND minimum 8 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry OR
Masters degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND minimum 5 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry OR
Ph.D. in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND minimum 0-3 years experience in a product development or formulation laboratory in the academic, pharmaceutical or biotechnology industry
Special knowledge or skills needed and/or licenses or certificates required
• Hands-on knowledge and experience in designing and conducting pharmaceutical formulation and process development studies with high scientific standard of oral solid/liquid dosage forms REQUIRED
• Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements REQUIRED
• Experience writing and reviewing technical documents (i.e., SOPs, investigations, protocols, reports, submission documents, etc.) REQUIRED
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI PM22