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Sr Chemist - Exempt

Menlo Park, CA 94025

Posted: 09/18/2023 Employment Type: Contract Job Category: Scientific Job Number: 583933 Is job remote?: No Country: United States

Job Description


Top 3 Things Seeking in a Candidate's Experience:
  • Competence in performing HPLC, GPC, and Dissolution analysis. Experience with Agilent OpenLab ChemStation and Agilent/Cirrus GPC is considered preferable.
  • Prior experience with drug polymer stents is preferable.
  • Strong record-keeping skills and adherence to GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices).
  • Experience in collaborating with external Contract Research Organizations (CROs) labs.

 

Education Required: Bachelor's degree in Analytical Chemistry, Chemistry, or related field.

Years' Experience Required: A minimum of 3 years of experience in pharmaceutical analytical testing. Competence in performing HPLC, GPC, and Dissolution analysis. Experience with Agilent OpenLab ChemStation and Agilent/Curis GPC and Prior experience with drug polymer stents is preferable.

A minimum of three years of experience in pharmaceutical analytical testing, including proficiency in conducting High-Performance Liquid Chromatography (HPLC), Gel Permeation Chromatography (GPC), and Dissolution analysis. Familiarity with Agilent OpenLab ChemStation and Agilent/Cirrus GPC systems is desired. Previous involvement with drug polymer stents is preferred.

 

Responsibilities may include the following and other duties may be assigned. 
 
  • Prepare buffers, reagents, and mobile phases required for HPLC Assay, impurity, and Dissolution analysis.
  • Perform analytical testing on raw materials, in-process samples, and finished goods using HPLC, GPC, and Dissolution Apparatus.
  • Collaborate and coordinate testing activities with external Contract Research Organization (CRO) laboratories, ensuring the timely submission of samples and the accurate exchange of data.
  • Conduct/scheduling sample testing to determine drug content, uniformity, release profiles, impurities, molecular weight, residual water, and residual acetone according to internal and external analytical procedures.
  • Review analytical data and documentation generated internally and by CROs to ensure accuracy, consistency, and compliance with established procedures.
  • Schedule and monitor preventive maintenance (PM) and calibration activities for analytical equipment, ensuring their optimal performance and reliability.
  • Procure laboratory supplies and reagents as needed to maintain an efficient workflow and support ongoing testing activities.
  • Maintain accurate and detailed records of all analytical testing, procedures, and results, adhering to Good Laboratory Practices (GLP) and Standard Operating Procedures (SOPs).
  • Participate in continuous improvement initiatives, contributing to the development of new analytical methods, procedures, and techniques.
  • Collaborate with cross-functional teams and provide R&D support as needed.

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.
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