Summary of 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.
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
Experience & Education:- 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.
Skills and Abilities:- 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
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
