Scientist II, Analytical Research & Development

Innoviva Specialty Therapeutics • Lexington, MA

2d • $127,000 - $145,000

About The Position

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.

Requirements

• 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, EcoSec, OMNIS
• Experience working in a GMP/GLP/GDP environment preferred
• Experience with managing vendors for analytical method transfers and instrument validation is a plus
• Experience working in small biotech or other highly collaborative, fast-paced environments.
• Self- motivated and strong problem-solving skills and the ability to work independently
• Excellent written and verbal communication, organizational, and interpersonal skills
• Demonstrated technical writing skills (protocols, reports)
• Flexible, enthusiastic with ability to work collaboratively in a dynamic environment

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree