Senior Analytical Scientist

2 weeks ago


Marlborough, Massachusetts, United States Randstad Life Sciences US Full time
Job Summary

The Senior Analytical Scientist will be responsible for executing and troubleshooting laboratory test methods, defining requirements for implementation of procedures, processes, and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality.

Key Responsibilities
  • Develop and revise technical reports and laboratory procedures, including SOPs, methods, and LIMS builds.
  • Execute and troubleshoot release, stability, and in-process testing in support of production activities.
  • Design and perform testing in support of method transfer/validation/qualification/verification.
  • Review and authorize data, perform analysis and interpretation of test results and trends.
  • Design and/or participate in method development, equipment qualification/validation studies, deviation, and OOS investigations.
  • Perform QC lab support activities, including sample management, reagent preparation, instrumentation maintenance, and instrument calibration.
  • Support and mentor junior team members.
  • Collaborate with other network sites to share best practices.
Requirements
  • B.S. degree in chemistry, biological sciences, or related field with 6+ years of experience or M.S. degree with 4+ years of experience in a GMP Quality Control role.
  • Prior laboratory hands-on experience with various analytical techniques, including HPLC, CE, DLS, UV-VIS spectroscopy, sub-visible particulate analysis, pH, osmolality, and other chromatographic and physiochemical techniques.
  • Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries.
  • Experience using LIMS as an end user, excellent technical writing and verbal communication skills.
  • Must be capable of observing and adhering to lab safety standards and procedures.
  • Successfully performs work independently with minimal instructions.
  • Strong interpersonal skills, highly collaborative within a multi-discipline team, and contributes to a supportive and positive work environment.
  • Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion.
  • Highly self-motivated and goal-oriented.

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