PRIMARY RESPONSIBILITIES:

Conduct routine/non-routine analysis of in-process, toxicology, finished drug substance and drug product samples (i.e. release and stability testing)
Manage new and ongoing development projects
Review analytical data for compliance to SOPs (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
Present and participate in internal and external scientific meetings
Assemble and document data for quality review
Revise SOPs as needed (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
Author and execute qualification/validation protocols and write reports
Author scientific reports and portions of Chemistry, Manufacturing, and Controls (CMC) section of regulatory filings
Conduct analytical investigations
May develop and/or optimize analytical methods
Applies knowledge of cGMP and GLP on a daily basis

REQUIREMENTS:

BS/MS degree in Chemistry or related field
At least 4 years (Research Associate II) or 7+ years (Sr. Research Associate) experience in an analytical development and quality control role
Practical knowledge of HPLC, MS, and GC
Knowledge and previous applications of cGMPs preferable
Experience following SOPs (i.e. Analytical Methods, Equipment Procedures, Material Specifications)
Ability to be the technical leader of a scientific project
Ability to interpret experimental results and correctly identify a path forward independently
Strong organizational skills
Experience recording data in laboratory notebooks or data collection forms
Comfortable with the operation and troubleshooting of instrumentation (lab equipment)
Communicate effectively, both verbally and in written form, to all levels of the organization
Ability to carry through on assignments, meet deadlines and time schedules
Ability to be flexible with workload and job duties to support team objectives
Experience managing development projects
Will build positive teamwork, encourage solutions, and solicit feedback to problems and demonstrate respectful behavior to others
Be an active listener; provide open, constructive feedback to suggestions or opinions presented

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