Senior Scientist

Our client's Commercial Attribute Sciences department is responsible for commercial analytical support, including method validation, method transfer, method remediation, method investigation support, process and product development as well as manufacturing and QC support.

The Scientist will work closely with a team of analytical chemists, organic chemists, engineers and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for manufacturing processes and products.

The Scientist will integrate and successfully utilize platform and prior product knowledge to advance company practices and ensure success of the commercial and clinical portfolio.

Basic Qualifications

• Doctorate degree PhD OR PharmD OR MD and 2 years of Experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience
• Define analytical control strategies and implement methodologies for late stage programs.
• Collaborate closely with drug substance and drug product Process Development and Quality colleagues.
• Collaborate with cross functional teams to facilitate activities at manufacturing and testing sites (contract and internal)
• Strong understanding of analytical methods with an emphasis on small molecules
• Experience in a wide variety of analytical techniques, including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, potency, etc.
• Developing and implementing methods for in-process testing, release and stability testing.
• Familiarity with analytical testing requirements for immediate release and controlled release oral solid dosage drug products.
• Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
• Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
• Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines
• Solid communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
• Working well in cross-functional teams, and across various geographic locations in different time zones
• Excellent technical writing skills and attention to detail in data review, authoring methods, specifications, technical reports and regulatory filing documents