Analytical Chemist in Springfield, MO at AMRI

Date Posted: 3/15/2020

Job Snapshot

Job Description

Description
AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
As a member of the QA/QC team to ensure the timely execution of analytical method transfers, method development and validations, and initial qualification and retesting of analytical reference standards.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
MAJOR RESPONSIBILITIES/aCCOUNTABILITIES:
  • 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, PSD , etc) for processes.
  • Validate and execute analytical methods for cleaning verification, raw material assay, stability testing, waste streams, Packaging Materials and final product release.
  • Update  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 QC 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 QC 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  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.

Secondary responsibilities/accountabilities
  • 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.
  • Backup for Reference standards and Stability program testing. Perform as needed qualification of QC instruments as per Part 11 compliance and AMRI Global Standard of Computer Systems.


Qualifications
Qualifications: 
  • Ph.D. in analytical chemistry or related field (material sciences, organic chemistry) with experience in pharmaceutical analytical method development and validation OR a MS degree with at least 1-5 years of relevant years of 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.
Preferred Qualifications:
  • Demonstrate technical competency and the ability to learn new processes, technical subject matter and the ability to apply broad technical knowledge to solve specific problems.
  • Demonstrate problem solving and analytical, report writing, computer literacy, verbal communication, presentation and planning skills and abilities.

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, stand walk, hear, talk, hear and detect odors.  The employee is regularly use hands to finger, handle, or feel, reach with hands and arms.  The employee must rarely climb or balance and stoop, kneel, crouch, and crawl.  The employee must rarely lift and/or move up to (50) pounds.  Specific vision abilities required in this job include close vision, distance vision, peripheral vision, color vision, depth perception and ability to adjust focus.

Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee is regularly required to work in a normal analytical chemistry laboratory environment and a normal office environment, and is occasionally, required to enter the production area of a typical manufacturing facility which has moving mechanical parts, and may have fumes or airborne particles, extreme heat, wet and /or humid conditions, low levels of toxic or caustic chemicals, and outside weather conditions.  The noise level in the environment is usually moderate.

Job descriptions are not intended, and should not be construed, to be exhaustive lists of all responsibilities, skills, efforts, or working conditions associated with a job:  They are intended to be accurate reflections of those principal job elements essential for making fair pay decisions about jobs.
Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000. Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

Job: Development
Primary Location: US-MO-Springfield
Other Locations:
Organization: AMRI Springfield
Schedule: Full-time
Job Posting: Mar 15, 2020, 1:11:03 PM
Shift Type:

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AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.