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Monmouth Junction

    Sr. Scientist I, AR&D - Monmouth Junction, United States - Tris Pharma

    Tris Pharma
    Tris Pharma Monmouth Junction, United States

    1 day ago

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    Full time
    Description

    Tris Pharma, Inc. ) 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.

    We have a position in Monmouth Junction, NJ for an SR Scientist I, AR&D

    The Analytical Research and Development (AR&D) Senior Scientist I, under minimal guidance, performs analytical method development and troubleshooting of existing methods, designs and executes physical characterization studies to facilitate product understanding. Serving as analytical lead for assigned projects the incumbent provides analytical input to support complex technical investigations, guides highly specialized analytical tasks and conducts research on assigned problems and studies to support product development. She/he also prepares technical reports and other relevant scientific packages for internal and external use.


    • Carries out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs), and state, federal and local laws


    • Acts as AR&D lead for assigned development projects liaising with Product Development (PD) department on analytical deliverables


    • Sets up and operates analytical instruments to support sample testing, including High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), Infrared Spectroscopy (IR), Thin Layer Chromatography (TLC), automatic titration, Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Liquid Chromatography–Mass Spectroscopy (LC-MS) and dissolution apparatus


    • Performs analytical method development and troubleshooting of existing analytical methods for in process (IP), finished products (FP) and stability (ST) sample testing; Performs and guides laboratory analyses of raw materials, IP, FP and ST samples


    • Designs and executes physical characterization studies to facilitate product understanding, such as rheological, microscopy, surface area and thermal studies


    • Designs, guides and performs reverse engineering studies of Reference Listed Drug (RLD) to support Product development


    • Designs, guides and performs pre-formulation studies (i.e, pH solubility, pH stability, excipients compatibility studies, etc.) in collaboration with PD


    • Performs trend analysis of development stability results, investigates Out of Specification (OOS) and Out of Trend (OOT) results in support of project directives


    • Provides analytical input to support complex technical investigations


    • Documents all testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs); Prepares analytical method development reports, technical protocols/reports and scientific packages for internal and external use


    • Creates and reviews ARD SOPs, as needed

    Requirements

    QUALIFICATIONS

    Bachelors degree in Chemistry or related science field and minimum 10 years experience in analytical development in the pharmaceutical or biotechnology industry OR Masters degree in Chemistry or related science field and minimum 8 years experience in analytical development in the pharmaceutical or biotechnology industry OR PhD in Chemistry or related science field and minimum 3 years experience in analytical development in the pharmaceutical or biotechnology industry.


    • Strong knowledge and experience of physical characterization, thermal, spectroscopic and chromatographic techniques and concepts REQUIRED


    • Hands on experience in setting up and operating multiple analytical instrumentation which may include: HPLC, UV/Vis, GC, TLC, ICP-MS and dissolution apparatus REQUIRED


    • Strong working experience in designing and executing pre-formulation, analytical and physical characterization studies with high scientific standard REQUIRED


    • Strong technical writing skills, including SOPs, investigations, protocols and reports REQUIRED


    • Ability to train and mentor lower levels scientist REQUIRED

    · Generics experience PLUS

    Physical requirements

    Laboratory based position

    Ability to use Personal Protective Equipment (PPE)

    Ability to stand for extended periods

    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.

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