Summary:
The Scientist I/II/Senior Scientist, Analytical Development - Will create physiochemical/bioanalytical methodologies for identifying and introducing new therapies in the Oncology, Neurology and Rare Diseases focuses. They will be in charge of developing and carrying out laboratory experiments on their own, consolidating pertinent findings into reports, and presenting outcomes to internal and external stakeholders. The ideal candidate will be at ease working in a fast-paced, cross-functional workplace.
Responsibilities:
- Development and support of CE methods to for the analysis of proteins, oligonucleotides, carbohydrates and large molecules from products.
- Development and support of HPLC/UPLC methods (SEC, IEX, and RP using UV, FLR, and CAD) to measure the CQA's.
- CE and HPLC/UPLC testing of in-process, drug substance, and drug product samples.
- Participating in tech transfer protocols to transfer created methodologies and expertise to the quality control team.
- Write and Review analytical test methods, protocols, and technical reports.
- Setting strategic goals, creating workplans, and discussing findings with internal and external stakeholders/customers.
Requirements:
- A PhD in Biochemistry, Analytical Chemistry, or a related discipline with 2+ years of industry experience, or a Master's degree in Biochemistry, Analytical Chemistry, or a related discipline with 6+ years of industry experience, or a BS in Biochemistry, Analytical Chemistry, or a related discipline with 11+ years of industry experience, or an equivalent combination of education and experience.
- Ability to create CE and HPLC/UPLC/NMR methodologies to characterize or measure the CQAs of in-process, drug material, and drug product samples has been demonstrated.
- Use of excellent oral and written communication skills to present findings to a broader scientific audience and to author technical documents (protocols, reports, and SOP's).
- Experience with QbD and DOE.
- Success working in a dynamic, cross-functional environment.
