Scientist I/II, Analytical Development
We are dedicated to discovering, developing and commercializing therapies that transform patient lives and advance patient care by changing treatment paradigms in thrombosis and other hematologic diseases.
The company’s two FDA approved medicines are Bevyxxa® (betrixaban), the first and only oral, once-daily Factor Xa inhibitor, and Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote for the Factor Xa inhibitors rivaroxaban and apixaban. The company also is advancing cerdulatinib, a Syk/JAK inhibitor for the treatment of hematologic cancers. These compounds come from our own internal research efforts and represent important advances to address significant unmet needs.
We are employing novel strategies that may increase the likelihood of clinical, regulatory and commercial success of our potentially lifesaving therapies.
The Scientist I/II, Analytical Development will work in a biopharmaceutical analytical development group responsible for analytical method development, method qualification/validation and QC transfer of active pharmaceutical ingredients (API) and drug products throughout the development pipeline. Development of immunoassays and bioassays used to characterize, establish, and monitor both the purity and strength of drug substances and products, analytical method development/optimization and assay transfers to QC and/or contract testing laboratories is a core responsibility. Experience with various analytical techniques such as HPLC, CE, SDSPAGE, Western Blot, UV/Vis and spectroscopic techniques is a plus. The successful candidate will also review and/or prepare validation protocols, reports and GMP controlled documents related to release and stability testing of drug substance and drug product. Familiarity with, and understanding of industry standards for regulated pharmaceutical testing is required. The Scientist will work in a team environment with members of the Analytical, Formulations and Quality groups along with scientists from related disciplines throughout the company.
- Responsible for assay development/qualification/trouble shooting and assay transfer to Contract Testing Labs
- Support characterization and comparability assessment of protein pharmaceuticals
- Provide technical support for analytical sections of regulatory filings
- Provide technical support for OOS/OOT and deviation investigations
- Plan and organize experiments to meet specific technical objectives
- Prepare and/or review written technical reports, SOPs and regulatory filings
- Adhere to company procedures and policies for laboratory documentation, safety and quality
- Use good scientific judgment in all activities
- Participate in group and individual meetings to establish priorities, organize activities and communicate results
- Requires a PhD in a scientific discipline or equivalent industry experience and training; 3+ years (Scientist I) or 5+ years (Scientist II) of experience in a research or biotechnology/pharmaceutical drug development environment
- Proficient with ELISA and bioassays as well as some combination of HPLC, SDS-PAGE, Western Blot, CE-SDS and clEF
- Experience working with proteins and associated analytical methods
- Knowledge of relevant US/EU regulatory and quality requirements and standards
- Knowledge of Softmax, Chromeleon, Empower and/or Chemstation software is a plus
- Knowledge of Good Laboratory Practices and/or Quality Control related cGMPs