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Senior API Chemist in Springfield, MO at AMRI

Date Posted: 4/23/2019

Job Snapshot

Job Description

Sr. Chemist API

 

AMRI provides global contract research and manufacturing including Quality Control services to the pharmaceutical and biotechnology industries.  

The Sr.  Chemist API is an integral part of the AMRI team, contributing to our success by providing technical support and guidance to Quality Control for investigations, analytical support for Regulatory Affairs in deficiency responses, and analytical technical support for process investigations, often with minimal supervision.  A deep understanding of analytical chemistry, separation science, and GMP regulations in the pharmaceutical industry is required.

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.


In this role, you will:   

  • Execute contract projects independently.  Document and report results of development and experimentation to Department Head. 
  • Development and evaluation of new chemical process technology and methods.  Introduce, optimize, validate and support new processes into the laboratory, kilo lab, plant, or pilot plant facility.
  •  Develop strategies to optimize production processes with respect to yield, quality, throughput, cost and minimization of waste streams.  Implement programs as required to optimize processes and resolve issues.
  • Prepare laboratory, kilo-scale and pilot-scale quantities of materials.
  • Provide detailed instruction and/or training to site employees.
  • Prepare and evaluate process descriptions, procedures, process flow diagrams, process summaries, throughput, mass balance and chemical process information, raw materials and process economics.
  • Write detailed reports on work and activities including periodic reviews of work and special work summaries such as validation reports, process summaries, etc., as required
  • Search and review scientific literature as required to plan and conduct sound and reasonable experimental strategies in a concise and expeditious manner.
  • Ability to supervise a project team and directly communicate with customers in consultation with AMRI/Euticals marketing team, and suppliers, to address technical issues.
  • Regularly communicate and present results of work performed in a clear, concise and accurate manner to Department Head and others.
  • Prepare and review written instructions (batch sheets, SOP’s etc.) to ensure that the products are made safely and under current good manufacturing practices.
  • Maintain complete and up to date files for existing projects.
  • Review proposed changes from a safety, practicality, feasibility, and GMP perspective following “Management of Change” protocol.
  • Perform laboratory experiments that are scientifically sound and generate valid data for making technologically sound decisions.  Laboratory technique must be reproducible with no inherent bias.
  • Conduct all job responsibilities in a manner consistent with all applicable safety and environmental laws and regulations, company policies and procedures, site chemical hygiene plan, regulations, and commit to continuously improve safety and environmental performance.
  • Keep the R&D Director up to date and informed of any significant results, events, deviations from expected results, or work being conducted or envisioned that may impact the business.
  • Perform statistical evaluations of laboratory and plant data to determine relevance and applicability of data.
  • Work with Analytical group to assist in development of analytical methodology or standards for new or revised processes.

Qualifications and background to be successful in this role:

 

Required:

  • BS/BA degree with minimum of 10 years of applicable experience or MS/Ph.D. degree with a minimum of 5 years of applicable experience in analytical chemistry

  • Ability to read, analyze and interpret professional/technical procedures and government regulations.  Ability to write reports and procedure manuals.

  • Ability to use and interpret data from modern analytical equipment such as NMR, HPLC, IR, etc.

  • Ability to solve practical problems and deal with variables where limited standardization exists.  Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

  • Ability to perform basic math functions, compute ratios, rate, percent, commissions and discounts.  Ability to create and interpret graphs and charts.

  • Strong analytical skills; excellent oral and written communication skills and the ability to work independently.  

Preferred:

  • Strong presentation skills in showcasing information and ability to respond to questions from groups or managers, clients, customers, vendors and general public in a confident and accurate manner is a strong plus.

  • Experience with regulations and FDA

  • An assertive and detail oriented personality is important with an innate desire to understand and learn chemical processes and a natural curiosity driving invention

 

All interested applicants must apply online.  AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness.  Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply. 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.

Job Requirements

Sr. Chemist API

 

AMRI provides global contract research and manufacturing including Quality Control services to the pharmaceutical and biotechnology industries.  

The Sr.  Chemist API is an integral part of the AMRI team, contributing to our success by providing technical support and guidance to Quality Control for investigations, analytical support for Regulatory Affairs in deficiency responses, and analytical technical support for process investigations, often with minimal supervision.  A deep understanding of analytical chemistry, separation science, and GMP regulations in the pharmaceutical industry is required.

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.


In this role, you will:   

  • Execute contract projects independently.  Document and report results of development and experimentation to Department Head. 
  • Development and evaluation of new chemical process technology and methods.  Introduce, optimize, validate and support new processes into the laboratory, kilo lab, plant, or pilot plant facility.
  •  Develop strategies to optimize production processes with respect to yield, quality, throughput, cost and minimization of waste streams.  Implement programs as required to optimize processes and resolve issues.
  • Prepare laboratory, kilo-scale and pilot-scale quantities of materials.
  • Provide detailed instruction and/or training to site employees.
  • Prepare and evaluate process descriptions, procedures, process flow diagrams, process summaries, throughput, mass balance and chemical process information, raw materials and process economics.
  • Write detailed reports on work and activities including periodic reviews of work and special work summaries such as validation reports, process summaries, etc., as required
  • Search and review scientific literature as required to plan and conduct sound and reasonable experimental strategies in a concise and expeditious manner.
  • Ability to supervise a project team and directly communicate with customers in consultation with AMRI/Euticals marketing team, and suppliers, to address technical issues.
  • Regularly communicate and present results of work performed in a clear, concise and accurate manner to Department Head and others.
  • Prepare and review written instructions (batch sheets, SOP’s etc.) to ensure that the products are made safely and under current good manufacturing practices.
  • Maintain complete and up to date files for existing projects.
  • Review proposed changes from a safety, practicality, feasibility, and GMP perspective following “Management of Change” protocol.
  • Perform laboratory experiments that are scientifically sound and generate valid data for making technologically sound decisions.  Laboratory technique must be reproducible with no inherent bias.
  • Conduct all job responsibilities in a manner consistent with all applicable safety and environmental laws and regulations, company policies and procedures, site chemical hygiene plan, regulations, and commit to continuously improve safety and environmental performance.
  • Keep the R&D Director up to date and informed of any significant results, events, deviations from expected results, or work being conducted or envisioned that may impact the business.
  • Perform statistical evaluations of laboratory and plant data to determine relevance and applicability of data.
  • Work with Analytical group to assist in development of analytical methodology or standards for new or revised processes.

Qualifications and background to be successful in this role:

 

Required:

  • BS/BA degree with minimum of 10 years of applicable experience or MS/Ph.D. degree with a minimum of 5 years of applicable experience in analytical chemistry

  • Ability to read, analyze and interpret professional/technical procedures and government regulations.  Ability to write reports and procedure manuals.

  • Ability to use and interpret data from modern analytical equipment such as NMR, HPLC, IR, etc.

  • Ability to solve practical problems and deal with variables where limited standardization exists.  Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

  • Ability to perform basic math functions, compute ratios, rate, percent, commissions and discounts.  Ability to create and interpret graphs and charts.

  • Strong analytical skills; excellent oral and written communication skills and the ability to work independently.  

Preferred:

  • Strong presentation skills in showcasing information and ability to respond to questions from groups or managers, clients, customers, vendors and general public in a confident and accurate manner is a strong plus.

  • Experience with regulations and FDA

  • An assertive and detail oriented personality is important with an innate desire to understand and learn chemical processes and a natural curiosity driving invention

 

All interested applicants must apply online.  AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness.  Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply. 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.


Shift:  

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.

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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.