SUMMARY OF POSITION

The Analytical R&D Sr. Research Associate:

Provides analytical support of product development, including sample analysis and method pre-validation, accurately and concisely documents data, and reports results. Performs various analytical testing, including dissolution, HPLC and GC testing following established testing procedures for raw materials, finished products, and/or stability samples. Demonstrates a comprehensive knowledge of SOP's and cGxP regulations as related to the pharmaceutical analytical laboratory.

ORGANIZATION STRUCTURE

The Analytical R&D Sr. Research Associate reports to the Principal Scientist/Research Fellow, Analytical R&D.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

• Organize work schedule to complete assigned tasks efficiently and on schedule to ensure adherence to "Right-the First Time" philosophy
• Perform various analytical testing, including by Dissolution, HPLC, UV and GC following established testing procedures for raw materials, finished products, and/or stability samples
• Comprehend and follow established plan accurately in the performance of method pre-validations
• Comprehend and follow established testing procedures accurately in the performance of sample analysis
• With practical understanding of instrument operation, use available software to control instrumentation, collect data, process and calculate results, and report results
• Perform testing to evaluate physical characteristics of raw materials and finished products
• Independently organize work schedule to complete assigned tasks efficiently and on schedule
• Work with minimal supervisory direction for routine tasks
• Maintain accurate record of analysis and perform documentation to company standards
• Perform job functions in a safe manner consistent with site safety practices and regulatory (e.g. - OSHA) requirements
• Other duties as assigned

QUALIFICATIONS

• BS or MS in Chemistry, Biochemistry, Microbiology or Biology or related discipline
• 3-5 years of experience for MS, 4-7 years of experience for BS in a pharmaceutical laboratory environment
• Understanding of cGXP requirements preferred
• Organization, communication and interpersonal skills

GMP DECISION-MAKING AUTHORITY

Responsible for decisions related to:

• When laboratory management must be notified to determine whether an investigation is warranted.
• Whether they have been trained to perform a GMP task.
• Suitability of analytical equipment/instruments for use.

We are an EEO Employer, including disability & vets.