Sr. Scientist, Product Development
Tris Pharma, Inc. (www.trispharma.com) is a rapidly growing, technology-driven pharmaceutical company engaged in branded and generic product development. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Sr Scientist, Product Development.
This Senior Scientist, Product Development (PD) is responsible for conducting pre-formulation, formulation and process development studies as well as current Good Manufacturing Practices (cGMPs) pilot and pivotal batches to support regulatory submissions and business needs. She/he collaborates closely with other functions within Research and Development (R&D) including, but not limited to: Analytical and Project Management and outside R&D including, but not limited to: Regulatory, Technical Services, Quality, Clinical to ensure project milestones are met. She/he adheres strictly to company policies and current industry standards (cGMP, Good Laboratory Practices (GLPs), etc.).
• 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 executes product development activities, including pre-formulation, formulation and process development studies, following Quality by Design (QBD) principles, to ensure project deadlines and scientific standards are met; Performs physical and chemical characterization in liaison with analytical teams; Documents findings in laboratory notebooks and compiles technical reports
• Plans, coordinates and manufactures GMP pilot and pivotal batches, including protocols and batch records and reports
• Ensures cleanliness and functioning of lab equipment and instruments are properly maintained
• Authors regulatory submission documents 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)
• Creates and revises SOPs as needed. Collaborates with QA on investigations, CAPAs, and change controls to ensure timely closure
• Trains new employees and mentors lower level scientists, as needed
REQUIRED EDUCATION MUST INCLUDE:
Bachelors degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND minimum 10 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 8 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry OR
Ph.D. 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.
• In depth, hands on experience in designing and conducting pharmaceutical formulation and process development studies with high scientific rigor, supporting multiple dosage forms (i.e., solid, liquid and/or extended release, etc.) REQUIRED
• Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members REQUIRED
• Working knowledge of Food and Drug Administration (FDA), Occupational Health and Safety Administration (OSHA), Drug Enforcement Agency (DEA), cGMPs and GLPs regulations and guidances REQUIRED
• Hands on experience writing SOPs, investigations, protocols and reports 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.