Analytical Chemist
at Albany Molecular Research, Inc

Date Posted: 8/2/2017

Job Description

Analytical Chemist in Springfield, MO

To provide technical leadership to local Global API Analytical Technical Support team and to ensure the timely execution of analytical method transfers, method development and validations, and initial qualification and retesting of analytical reference standards.
RESPONSIBILITIES
  • Develop and validate chromatographic (HPLC, GC, and IC) methods for the analysis of pharmaceutical active ingredients and their precursors (intermediates). 
  • Develop and validate as needed other analytical methods required by regulatory agencies for a pharmaceutical active ingredient and its precursors.
  • Develop and qualify in-process controls (HPLC, GC, etc) for processes.
  • Validate analytical methods for cleaning verification, raw material assay, stability testing, waste streams, and final product release.
  • Modernize analytical methods for existing products and processes.
  • Develop validation protocols, conduct validation work and write validation reports. 
  • Perform appropriate testing for specification development.
  • Ensure that all IPC’s are performed on laboratory experiments before they are used to monitor a kilo lab, pilot plant or manufacturing run.        
  • Provide analytical support for CRD and Pilot Plant projects.  Work with multidisciplinary product and technology teams.
  • Coordinate instrument qualification, maintenance and repair activities for AD equipment.  Maintain instrument logs and records.
  • Operate in compliance with current Good Manufacturing Practices, Good Laboratory Practices and applicable ICH and FDA requirements.
  • Maintain supplies and materials for the GAATS area.
  • Assist in the preparation of responses to request for proposal / quote, project scope assessments and project timelines for new projects, as needed.
  • Document and record work observation and results according to written SOP’s.
  • Facilitate detailed process understanding by developing analytical methods in a timely fashion to elucidate the structures and quantities of impurities / side products present in reaction mixtures, process streams as well as intermediates and finished products.
  • Work with CRD staff to develop an understanding of impurity profiles for Active Pharmaceutical Ingredients and regulated intermediates.
  • Ensure that work in GAATS is done safely and in accordance with the site chemical hygiene plan, following any additional regulatory requirements that may apply.
  • Conduct all job responsibilities in a manner consistent with all applicable safety and environmental laws and regulations, company policies and procedures, regulations and commit to continuously improve safety and environmental performance.
  • Participate in Continuous Improvement Efforts by identifying work-practices to reduce costs and/or improve throughput and quality and bringing them to the attention of laboratory management.
  • Keep up to date with relevant developments in chemistry and laboratory practices and bring them to the attention of the laboratory management.
  • Approve reports, methods, and other documents as needed in the absence of supervisor.

Job Requirements

  • A minimum of a Ph.D. in analytical chemistry or related field (forensic chemistry, material sciences, organic chemistry) with no relevant experience (pharmaceutical analytical method development and validation), a MS degree with at least 1-5 years of relevant experience, or a BS degree with at least 5 years of relevant experience.
  • Must have a practical working knowledge of the operation of and maintenance of common analytical laboratory instruments such as GC, HPLC, IR, NMR, LC/MS and GC/MS and be willing to develop expertise in statistical design of experiments, Process Analytical technology, QbD, and or high through-put analyses.
  • Demonstrate technical competency and the ability to learn new processes, technical subject matter and the ability to apply broad technical to solve specific problems.
  • Demonstrate problem solving and analytical report writing, computer literacy, verbal communication, presentation and planning skills and abilities.

Shift:

Job Snapshot

  • Employee Type: Full-Time
  • Location: Springfield, MO
  • Job Type: Science
  • Experience: Not Specified
  • Date Posted: 8/2/2017

About Us

For more than 20 years, AMRI has provided integrated drug discovery, development and manufacturing services – all while adapting to the rapidly changing needs of the pharmaceutical, biotechnology and related industries.

AMRI is a continually evolving organization and always looking for talented people. The company provides equal employment opportunities to all individuals without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, citizenship or any other characteristic protected by law. To ensure that employment decisions are consistent with equal employment opportunities, AMRI imposes only job-related requirements for these opportunities.

If you would enjoy working for a company devoted to delivering better outcomes for the pharma industry, and if you are looking to join a global team of dedicated professionals, we invite you to join the Albany Molecular Research Talent Network today!

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