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:
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Organize work schedule to complete assigned tasks efficiently and on schedule to ensure adherence to “Right-the First Time” philosophy
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Perform various analytical testing, including by Dissolution, HPLC, UV and GC following established testing procedures for raw materials, finished products, and/or stability samples
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Comprehend and follow established plan accurately in the performance of method pre-validations
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Comprehend and follow established testing procedures accurately in the performance of sample analysis
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With practical understanding of instrument operation, use available software to control instrumentation, collect data, process and calculate results, and report results
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Perform testing to evaluate physical characteristics of raw materials and finished products
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Independently organize work schedule to complete assigned tasks efficiently and on schedule
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Work with minimal supervisory direction for routine tasks
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Maintain accurate record of analysis and perform documentation to company standards
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Perform job functions in a safe manner consistent with site safety practices and regulatory (e.g. – OSHA) requirements
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Other duties as assigned
QUALIFICATIONS
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BS or MS in Chemistry, Biochemistry, Microbiology or Biology or related discipline
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3-5 years of experience for MS, 4-7 years of experience for BS in a pharmaceutical laboratory environment
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Understanding of cGXP requirements preferred
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Organization, communication and interpersonal skills
GMP DECISION-MAKING AUTHORITY
Responsible for decisions related to:
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When laboratory management must be notified to determine whether an investigation is warranted.
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Whether they have been trained to perform a GMP task.
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Suitability of analytical equipment/instruments for use.
We are an EEO Employer, including disability & vets.