Sr. Analytical Development Scientist

The Position 

This position is in the Analytical Development (AD) Group within the CMC Manufacturing Organization. A Sr. AD Scientist will support method development/validation activities for new drug substances and drug products. He/She will also support testing required for drug substance and drug product process development, characterization of impurities, and other activities associated with GLP Toxicology and cGMP Clinical Trial materials. This position reports to AD Management. 

Responsibilities 

• Provide accurate analytical results in support of new and on-going projects 

• Work independently and with project teams to meet project timelines and deliverables 

• Provide leadership, technical guidance, and development to junior scientists 

• Serve as Analytical Project Coordinator or Lead for on-going or new projects and take ownership of analytical requirements needed, including scheduling, prioritizing and coordinating analytical testing 

• Prepare technical reports, presentations, SOPs, and policies and procedures 

• Independently design and initiate development of analytical methods and improvement of existing ones, to support all stages of API (active pharmaceutical ingredient) and drug product development 

• Apply advanced scientific principles, theories and concepts to a broad range of research problems and develop innovative solutions for analytical problems related to drug substances and/or drug products in compliance with appropriate Standard Operating Procedures (SOPs) and regulatory guidelines. 

• Develop specifications and test methods for raw materials, in-process and isolated intermediates, as well as drug products. 

• Design and excecute non-routine experiments with supervision

• Analyze and interpret data/results and outcome of experiments and propose appropriate follow-up with supervision 

• Write project documentation (Analytical test methods, developmental reports, validation reports, and protocols) of higher complexity 

• Collaborate with other groups and activities necessary to ensure project deliverables are met 

• Perform peer review of notebooks, protocols, and validation documentation 

• Monitor and report progress of AD project deliverables within agreed project timelines 

• Perform calibration, maintenance, and troubleshooting of analytical equipment 

• Identify capital equipment and requirements for the AD laboratory 

• May perform release testing of raw materials, stability study samples, method validation, and method transfer activities for toxicology and clinical trial activities when needed 

• Embrace cGMP requirements for all work associated 

• Other duties as assigned

Requirements:

• Ph.D. in Chemistry (or related field) with 3+ years of relevant experience, M.S. in Chemistry (or related field) with 7+ years of relevant experience, or B.S in Chemistry (or related field) with 10+ years of relevant experience 

• Proficiency with various related analytical techniques, such as HPLC, GC, FTIR, UV/Vis, LC/MS, KF, etc.

• Expertise in method development and validations in support of drug substance and drug product development, and manufacture 

• Skills and knowledge in handling, analyzing and characterizing chemicals, pharmaceuticals and related organic molecules 

• Expertise with analytical instrumentation, and test methodology/validations 

• Knowledgeable with data acquisition systems, and cGMP policies and practices 

• Demonstrated experience with analytical instrumentation theory and practice as well as pharmaceutical drug substance and drug product development and processes 

• Has a solid understanding of CMC regulatory requirements for pharmaceutical products 

• Knowledgeable of cGMP, ICH, CDER requirements 

• Understanding of theories and principles of synthetic organic chemistry 

• Pay attention to detail 

• Can independently perform tasks assigned 

• Can be flexible with changing priorities