Tris Pharma, Inc Product Development, Sr. Scientist I in Monmouth Junction, New Jersey
DescriptionTris 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 Senior Scientist. SummaryThe Product Development (PD) Senior Scientist I, under minimal guidance, designs, plans and conducts pre-formulation, formulation and process development activities as well as scale-up trials of complex projects using risk-based approach. The incumbent plans, coordinates and executes current Good Manufacturing Practices (cGMPs) pilot and pivotal/submission batches, including all required documentation. She/he prepares technical and product development reports and regulatory submission document and performs critical analysis. ESSENTIAL FUNCTIONS Primary duties/responsibilities * Carries out responsibilities in accordance with the organization's policies, Standard Operating Procedures (SOPs), and state, federal and local laws * Designs, plans and conducts product development activities, including pre-formulation, formulation, process development and scale up studies of complex projects to ensure good scientific standards are met * Documents all study details and results in laboratory notebooks and batch records compliant with current Good Documentation Practices (cGDP) and cGMP; Summarizes data, discusses results and makes conclusions in technical reports; Meets project deadlines and performance standards, as assigned * Creates invention disclosures; Collaborates with internal and external counsel to perform patent landscape analysis, draft patent applications, and respond to office actions * Utilizes risk-based approaches and Quality by Design (QbD) principles in guiding pharmaceutical development and identifying critical quality attributes (CQA), critical material attributes (CMA), critical process parameters (CPP) and control strategies. Uses problem solving tools to trouble shoot, as needed * Designs and conducts physical and chemical characterization in liaison with analytical teams * Performs critical data analysis using statistical tools including stability analysis * Plans, coordinates and manufactures cGMP pilot and pivotal batches, including drafting of protocols, master batch records and reports * Liaises, coordinates and manages PD activities with external labs, Clinical Research Organizations (CROs) and Clinical Development Manufacturing Organizations (CDMOs), including cGMP manufacturing activities; Collaborates closely with other functions within and outside R&D to ensure project timelines are met * Presents and updates project status and issues/challenges to management * Supports technical services and operations to trouble-shoot scale up and commercial processes * Collaborates with, and assists, Regulatory Affairs with coordination and submission of pivotal batches to CROs * Ensures cleanliness and functioning of PD areas and proper maintenance of equipment and instruments; Supports review of qualification documents for process equipment * Authors regulatory submission documents for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA), supplements, annual reports and Investigator Responses (IR)/Complete Response Letters (CRLs), covering pharmaceutical development and manufacture, including product development reports * Creates and revises PD Standard Operating Procedures (SOPs), as needed * Collaborates with Quality Assurance (QA) department on investigations, Corrective Action Preventive Action (CAPAs) and changes controls, as needed; Supports Technical Services and Operations departments to troubleshoot scale up and commercial processes * Participates in training of new employees and mentors lower level scientistsRequirementsKNOWLEDGE/SKILLS/ABILITIES REQUIRED Minimum education and years of relevant work experience Bachelors degree in Pharmaceutical Science or related scientific field and minimum 10 years experience in pharmaceutical formulation and product development ORMasters degree in Pharmaceutical Science or related scientific field and minimum 8 years experience in pharmaceutical formulation and product development. ORPhD in Pharmaceutical Science or related scientific field and minimum 3 years experience in pharmaceutical formulation and product development Special knowledge or skills needed and/or licenses or certificates required * In depth experience designing and conducting oral controlled release solids and liquids pharmaceutical formulation and process development studies with high scientific standard of multiple dosage forms * Working knowledge of QbD and risk-based approaches * Working knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), OccupationalSafety and Health Administration (OSHA), SOPs and regulatory rules, regulations and guidelines * Strong technical writing skills and experience (i.e., SOPs, investigations, protocols, reports, submission documents, etc.) * Proficiency with Microsoft Office * Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members * Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines * Planning, organization and time management skills including the ability to support and prioritize multiple projects * Fluent in English (verbal and written) 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.