Analytical Chemist – Process Development Senior Scientist

Analytical Chemist – Process Development Senior Scientist

Requirements

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR
• Master’s degree and 3 years of scientific experience OR
• Bachelor’s degree and 5 years of scientific experience

Responsibilities

• Analytical method development, validation and troubleshooting for small molecule drug substances and drug products and in-process testing.
• Define analytical control strategies and implement methodologies for development of early phase clinical programs.
• Collaborate with drug substance and drug product process development colleagues.
• Manage activities at contract manufacturing and testing sites.
• May lead and develop a small group of scientists.

Preferred Qualifications

• PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
• Experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development.
• Strong understanding of small molecule analysis, structure elucidation, and solid-state characterization guided and informed by knowledge of organic chemistry.
• Experience in a wide variety of structure elucidation and physiochemical techniques including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, etc.
• Ability to develop and implement methods for in-process, release, and stability testing.
• Experience in 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, early phase development, 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, handle deliverables against timelines.
• Strong 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.
• Works well in cross-functional teams, and across various geographic locations in different time zones.
• Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents.
• Experience with synthesis, method development and attribute characterization for small molecules, peptides or oligonucleotides.