Scientist II, Analytical Research & Development

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Full Time Professional Nortiva, Lexington, MA, US

5 days ago Requisition

Salary Range: $ To $ Annually

Nortiva Bio, Inc , a subsidiary of Innoviva, Inc., is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. The company’s proprietary LYNX™ drug delivery platform represents a major advancement in oral drug delivery, enabling the creation of medicines designed to last a week or longer in a single oral dose. Our near-term focus is on advancing clinical programs in therapeutic areas where weekly or monthly doses would improve adherence and health outcomes.

The Scientist II in Analytical Research & Development will lead efforts in characterizing Nortiva’s long-acting oral drug products. Nortiva’s novel drug delivery platform uniquely combines elements of controlled drug delivery, traditional and non-traditional formulation components and processes, and dynamic structural features required for gastric residence.

The Scientist will be primarily responsible for developing methods to assess key properties of Nortiva’s long-acting oral products, including drug release, drug stability, and physical and chemical characteristics of polymer blends. This role will also be required to perform phase-appropriate qualifications and validation to support clinical programs. In addition, the Scientist will contribute to developing appropriate control strategies, drafting and reviewing regulatory CMC sections, and supporting other R&D functions as part of a collaborative and diverse team.

• Develop, qualify, and validate phase-appropriate characterization methods using analytical techniques including, but not limited to, high-performance liquid chromatography (HPLC), gel permeation chromatography (GPC), and dissolution for one or more drug products from early-stage feasibility through clinical development and stability
• Partner closely with Formulation to advance the biopharmaceutical assessment strategy by investigating and characterizing in‑vitro drug release, and predicting and correlating with in‑vivo exposure
• Perform release and stability testing of drug product intermediates and finished products to ensure their suitability for preclinical or clinical studies according to cGDP and cGLP practices.
• Collaborate with Manufacturing to troubleshoot and investigate issues arising during manufacturing campaigns through methodical and science-driven approaches
• Improve current analytical workflows by identifying and implementation innovative solutions that can increase efficiency and effectiveness from sample preparation to data analysis and reporting
• Compile, summarize and present key findings and analytical development strategies to cross-functional teams and company leadership
• Operate, maintain and troubleshoot laboratory equipment and instruments
• Author controlled documents including SOPs and regulatory filings

• Ph.D. in Analytical Chemistry, Polymer Chemistry, Pharmaceutical Sciences, or related field with 2+ years of relevant industry experience;
  Master’s degree with 5+ years of relevant industry experience; or Bachelor’s degree with 7+ years of relevant industry experience
• Experience developing methods based on various analytical techniques, including but not limited to HPLC, GPC, UV/Vis, fluorescence, thermal analysis, and software such as Empower, TRIOS, Eco Sec, OMNIS
• Experience working in a GMP/GLP/GDP environment preferred
• Experience with managing vendors for analytical method transfers and instrument…