R&D Method Development Chemist (ID#011)

Tampa, Florida

Post Date: 05/23/2017 Job ID: JN -052017-8865
R&D Method Development Chemist
Currently recruiting for an Analytical Method Development Chemist for a pharmaceutical company in the Tampa Bay, FL area.

Great Benefits, Company Culture, 4 DAY WORK WEEK!


Overview
The R&D laboratory supports, development and validation of methods analytical test methods, evaluation and testing of raw materials, and testing of non-commercial materials to support product development. The department provides analytical services to manufacturing, process development, validation and new material qualifications. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements

Responsibilities
  • Independently develop, validate, and routinely execute test methods in support of Drug Substances and Drug Products as required. Analyze data, document results, maintain laboratory notebook according to cGMP and Internal guidelines. Communicate results in written and oral presentations. Help in writing Procedures, Specifications and Test Methods. Keep abreast of literature in field; help train colleagues; contribute to continuous improvement within the group. Comply with FDA, EPA and OSHA regulations, performing all work in a safe manner. Maintain proper records in accordance with all SOP's and policies.
  • Ability to develop and validate instrumental methods in support of Drug Substances and Drug products.
  • Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
  • Preparation of reagents/standards/medias needed for analysis according to established methods.
  • Disposal of hazardous waste according to environmental regulations and company/ departmental procedures.
  • Assures right-first-time execution of departmental methods and SOPs.
  • Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
  • Writes and reviews analytical methods, deviations, protocols, SOPs and any other technical document.
  • Lead all analytical method transfer activities as required by their area.
  • Supports Material Evaluation Process for new materials.
  • Provides project support for new product development which requires a close working relationship directly with Customers as well as suppliers.
  • Conducts and writes laboratory investigations using the appropriate Root Cause Analysis tools.
Requirements:
  • Minimum Bachelor s degree from four-year college or university in any of the following disciplines: Chemistry, Biology, Microbiology, or related sciences (as applicable)
  • Minimum of 5 years relevant pharmaceutical laboratory/analytical experience; GMP environment
  • Must be proficient with method development and method validation
  • U.V. spectroscopy, IR and AA instrumentation, H.P.L.C. and G.C. instrumentation, Dissolution testing, expertise in wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions.

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