Pace Analytical Services, LLC

RESPONSIBILITIES Perform analytical testing and data review of batch release, in process and/or stability samples of mRNA drug substance in cGMP compliant laboratory.. Executes routine procedures based on biochemistry methodologies, such as HPLC, UPLC, SoloVPE.Execute routine procedures based on bioassay methodologies, such as plate-based assays (ELISA, ddPCR, ribogreen), gel electrophoresis, western blot and cell based assays.. Support qualification and validation testing of QC methods in area of expertise.. Routinely provide performance feedback and guidance to employees in addition to conducting formal evaluations and reviews QUALIFICATIONS BS or MS in analytical chemistry, biochemistry, or biotechnology or equivalence BS with 3+ years or MS (0+ years) of professional experience in the vaccine or pharmaceutical industry in the field of QC analytics or R&D. Preferred 2 years of experience in cGLP or cGMP lab.. Expertise in biochemical and bioassay techniques Proficient with lab software (LIMS, Empower, Bio-Rad Image Lab) Working knowledge of regulatory standards as they

quality control analyst

Sr. Quality Control Analyst/Group Leader ID 2024-4635 # of Openings 1 Job Locations US-MA-Waltham Category Science OVERVIEW This candidate will be responsible for laboratory activities in support of process development and industrialization and ensure the characterization of mRNA. These analyses include HPLC, ELISA, qPCR, western blot and more that support the process development. Provide leadership for a team of 7-12 employees. RESPONSIBILITIES Perform analytical testing and data review of batch release, in process and/or stability samples of mRNA drug substance in cGMP compliant laboratory.Executes routine procedures based on biochemistry methodologies, such as HPLC, UPLC, SoloVPE.Execute routine procedures based on bioassay methodologies, such as plate-based assays (ELISA, ddPCR, ribogreen), gel electrophoresis, western blot and cell based assays. Support the laboratory start-up activities, participate in validation activities.Authors revisions to SOPs for managerial review and approval.Execute troubleshooting with minimal guidance from supervisor or senior team members.Acts as trainer for specific methodology, responsible for training less experienced analysts on assays of expertise.Support qualification and validation testing of QC methods in area of expertise.Support and/or lead lab investigations.Participate in continuous improvement of laboratory safety and quality compliance.Assist with the development of new methods and processes. General laboratory activities and instrumentation including pipetting, preparation of solutions/samples/media, and operation of pH meters, autoclaves and analytical balances.General laboratory upkeep and supplies maintenance.Play a key role in new employee on-boarding including assisting the clients with pre-employment activities, arranging training plans and evaluating initial performanceWork with Pace management and HR to identify and address employee performance and client relation issues and successesCommunicate clearly and effectively in groups, 1 on 1, in person and in writing on a wide variety of topics.Routinely provide performance feedback and guidance to employees in addition to conducting formal evaluations and reviews QUALIFICATIONS BS or MS in analytical chemistry, biochemistry, or biotechnology or equivalence BS with 3+ years or MS (0+ years) of professional experience in the vaccine or pharmaceutical industry in the field of QC analytics or R&D. Preferred 2 years of experience in cGLP or cGMP lab.Expertise in biochemical and bioassay techniques Proficient with lab software (LIMS, Empower, Bio-Rad Image Lab) Working knowledge of regulatory standards as they

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