Associate Scientist, Analytical Development

The Position

This position is in the Analytical Development (AD) Group within the Process Development Organization. An AD Scientist will support method development/validation activities for new drug substances and drug products. Duties include support testing required for GLP Toxicology and cGMP Clinical Trial material release, a well as stability studies. This position reports to either AD Management or Senior AD staff. 

Responsibilities

• Work closely with senior scientists to provide accurate analytical results in support of new and ongoing projects
• Work with supervision to meet project timelines and deliverables
• Perform release testing of raw materials, stability study samples, method validation, and method transfer activities for toxicology and clinical trial activities
• With the supervision of the Analytical Development Manager, and/or Senior Scientist, assist with the design and initiation of development of analytical methods and improvement of existing ones, to support all stages of API (active pharmaceutical ingredient) and drug product development
• Evaluate and interpret scientific data and provide the significance of such with supervision
• Assist in the design and execution of non-routine experiments with supervision
• Analyze data/results and interpret the outcome of experiments and propose appropriate follow-up with supervision
• Write project documentation (Analytical test methods, developmental reports, and protocols) of medium complexity with supervision
• Embrace cGMP requirements for all work associated
• Calibration, maintenance, and troubleshooting of analytical equipment with supervision
• Other duties as assigned

Required:

• B.S. in Chemistry (or related field) with 1-5 years of relevant laboratory experience. A.S. in Chemistry (or related field) with 3-7 years of relevant laboratory experience
• Proficiency with some related analytical techniques, such as HPLC, GC, FTIR, UV/Vis, LC/MS, KF, etc., and willingness to learn new ones
• Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices
• Skills and knowledge in handling, analyzing, and characterizing chemicals, pharmaceuticals, and related organic molecules
• Understanding of basic theories and principles of synthetic organic chemistry
• Works well with others and in a team environment
• Pays attention to detail
• Can perform tasks assigned with minimal supervision
• Can be flexible with changing priorities

Compensation Description

The base salary range for this position in the selected city is $50,000 - $90,000 annually.