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Scientist QC Chem ADC

Job Post Index 205776-Sy##
Location Pearl River, NY
Description: Description
  • Consistently performs routine and more complex analytical chemistry activities with a high degree of independence.
  • Demonstrates technical expertise in one or more analytical areas.
  • Develops and validates analytical methods relating to the support of marketed products.
  • Compiles validation data into comprehensive reports.
  • Transfers analytical methods in support of new product launches and existing marketed products.
  • Applies creative ability and specialized scientific knowledge to solving marketed product analytical problems or evaluating changes to APIs and critical excipients used in marketed products.
  • Evaluates and implements new measurement technologies to improve sensitivity, selectivity, and/or the ability to characterize API’s, excipients, in-process materials, and finished products.
  • Applies statistics to data analysis and the design of experiments.
  • Generates analytical data for the purposes of determining the level of correlation to measurements that use Process Analytical Technology techniques.
  • Accountable for ensuring that analytical measurements are accurate and that methods are in compliance with FDA and/or other applicable regulatory agency guidelines, cGMP, and corporate requirements.
  • Conducts assays In addition to high technical competence understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development.
  • Continues to expand breadth of technical expertise.
  • Analyzes results Analyzes and interprets project/study/investigation/review results independently.
  • Makes tactical decisions independently based on the results.
  • Learns to develop project strategy in consultation with supervisor.
  • Trains more junior analysts in new and existing procedures, techniques and governmental regulations as directed by supervisor.
  • Mentors analysts by providing technical knowledge and support in resolving technical problems.
  • Takes initiative; seeks out additional assignments, etc.
  • Develops and evaluates plans for projects/studies/ investigations/reviews.
  • Completely responsible for planning and execution of all tasks needed to achieve routine goals.
  • Seeks advice on planning from supervisor when there are priority conflicts.
  • Begins to consider and consult with supervisor in area of long range planning for further development of the function.
  • Recommends corrective action to potential or observed cGMP violations.
  • Consult on analytical interpretations of methods and SOPs.
  • Builds credibility within the group by performing high quality work.
  • Coordinate communication and information.
  • Ordering equipment and laboratory supplies; pricing.
Skills: Qualifications
  • B.S. in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline with a minimum of 8 years of relevant Quality experience, preferably in the bio/pharmaceutical industry.
  • Or M.S. in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline with minimum of 6 years of relevant Quality experience, preferably in the bio/pharmaceutical industry.
  • Strong background in relevant analytical methods and techniques
  • Analytical Techniques and Methods In addition to high technical competence understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development.
  • Continues to expand breadth of technical expertise.
  • Ability to interpret and document test results according to standard operating procedures using all standard Quality systems
  • Strong background using LIMS may be desirable.
  • Advancing Methods Demonstrated ability to independently develop, document and troubleshoot methods of moderate complexity.
  • Knowledge of applicable compliance guidelines of the FDA or other regulatory bodies
  • Knowledge of test procedures such as USP, NF and ASC
  • Ability to review workload and determine most efficient and effective testing plan schedule.
  • Ability to leads teams comprised of immediate group members or to work cross functionally, if necessary.
  • Ability to independently design and carry out a series of studies/ reviews to solve a problem or evaluate a process/procedure.
  • Able to make independent contributions to the development of new technologies developing and revising methods and procedures to assure compliance with applicable regulations

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