Product Development, Sr. Scientist I in Monmouth Junction, New Jersey

DescriptionTris Pharma, Inc. (www.trispharma.com) is a number one privately-owned biopharmaceutical firm within the U.S. with a concentrate on growth and commercialization of modern medicines that deal with unmet affected person wants. Now we have greater than 150 US and Worldwide patents together with functions and have marketed a number of branded and generic merchandise within the U.S., have licensed our merchandise within the US and worldwide markets, and have a sturdy pipeline of modern merchandise spanning neuroscience and different therapeutic classes using our proprietary science and expertise. Our science and expertise make us distinctive, however it’s our group members that set us aside; they’re the engine that fuels Tris’ ardour and innovation. Tris colleagues perceive the criticality of working a profitable enterprise and take satisfaction within the firm’s success. However of equal significance to every member of the group is how we work together with each other each day. We consider in one another, and we consider in respectful, open and sincere communications to assist assist particular person and group success. Our Product Growth laboratory situated in our Monmouth Junction, NJ headquarters has an instantaneous want for an skilled PD Senior Scientist. AbstractThe Product Growth (PD) Senior Scientist I, beneath minimal steerage, designs, plans and conducts pre-formulation, formulation and course of growth actions in addition to scale-up trials of advanced tasks utilizing risk-based method. The incumbent plans, coordinates and executes present Good Manufacturing Practices (cGMPs) pilot and pivotal/submission batches, together with all required documentation. She/he prepares technical and product growth reviews and regulatory submission doc and performs vital evaluation. ESSENTIAL FUNCTIONS Major duties/obligations * Carries out obligations in accordance with the group’s insurance policies, Commonplace Working Procedures (SOPs), and state, federal and native legal guidelines * Designs, plans and conducts product growth actions, together with pre-formulation, formulation, course of growth and scale up research of advanced tasks to make sure good scientific requirements are met * Paperwork all examine particulars and ends in laboratory notebooks and batch information compliant with present Good Documentation Practices (cGDP) and cGMP; Summarizes information, discusses outcomes and makes conclusions in technical reviews; Meets mission deadlines and efficiency requirements, as assigned * Creates invention disclosures; Collaborates with inside and exterior counsel to carry out patent panorama evaluation, draft patent functions, and reply to workplace actions * Makes use of risk-based approaches and High quality by Design (QbD) rules in guiding pharmaceutical growth and figuring out vital high quality attributes (CQA), vital materials attributes (CMA), vital course of parameters (CPP) and management methods. Makes use of drawback fixing instruments to bother shoot, as wanted * Designs and conducts bodily and chemical characterization in liaison with analytical groups * Performs vital information evaluation utilizing statistical instruments together with stability evaluation * Plans, coordinates and manufactures cGMP pilot and pivotal batches, together with drafting of protocols, grasp batch information and reviews * Liaises, coordinates and manages PD actions with exterior labs, Scientific Analysis Organizations (CROs) and Scientific Growth Manufacturing Organizations (CDMOs), together with cGMP manufacturing actions; Collaborates intently with different capabilities inside and out of doors R&D to make sure mission timelines are met * Presents and updates mission standing and points/challenges to administration * Helps technical providers and operations to trouble-shoot scale up and business processes * Collaborates with, and assists, Regulatory Affairs with coordination and submission of pivotal batches to CROs * Ensures cleanliness and functioning of PD areas and correct upkeep of apparatus and devices; Helps evaluation of qualification paperwork for course of tools * Authors regulatory submission paperwork for New Drug Utility (NDA)/Abbreviated New Drug Utility (ANDA), dietary supplements, annual reviews and Investigator Responses (IR)/Full Response Letters (CRLs), masking pharmaceutical growth and manufacture, together with product growth reviews * Creates and revises PD Commonplace Working Procedures (SOPs), as wanted * Collaborates with High quality Assurance (QA) division on investigations, Corrective Motion Preventive Motion (CAPAs) and modifications controls, as wanted; Helps Technical Providers and Operations departments to troubleshoot scale up and business processes * Participates in coaching of recent workers and mentors decrease stage scientistsRequirementsKNOWLEDGE/SKILLS/ABILITIES REQUIRED Minimal schooling and years of related work expertise Bachelors diploma in Pharmaceutical Science or associated scientific area and minimal 10 years expertise in pharmaceutical formulation and product growth ORMasters diploma in Pharmaceutical Science or associated scientific area and minimal 8 years expertise in pharmaceutical formulation and product growth. ORPhD in Pharmaceutical Science or associated scientific area and minimal 3 years expertise in pharmaceutical formulation and product growth Particular information or abilities wanted and/or licenses or certificates required * In depth expertise designing and conducting oral managed launch solids and liquids pharmaceutical formulation and course of growth research with excessive scientific commonplace of a number of dosage kinds * Working information of QbD and risk-based approaches * Working information of Meals and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), OccupationalSafety and Well being Administration (OSHA), SOPs and regulatory guidelines, rules and tips * Robust technical writing abilities and expertise (i.e., SOPs, investigations, protocols, reviews, submission paperwork, and many others.) * Proficiency with Microsoft Workplace * Capability to work independently and collaboratively, as required, in a quick paced, matrixed, group atmosphere consisting of inside and exterior group members * Analytical pondering with problem-solving abilities and the flexibility to adapt to altering priorities and deadlines * Planning, group and time administration abilities together with the flexibility to assist and prioritize a number of tasks * Fluent in English (verbal and written) Tris Pharma, Inc. presents a extremely aggressive compensation and advantages package deal. To construct and improve our various workforce, we encourage functions from people with disabilities, minorities, veterans, ladies, LGBTQ, and many others.Tris Pharma, Inc. is an Equal Alternative Employer.