Quality Control Scientist

Location: Worchester, MA
Department: Azzur Worcester, LLC

Job Description

As a key member of the Quality Control team, the QC Scientist is responsible to ensure the methods  are in an appropriate GMP status prior to GMP manufacturing by leading the tech transfer activities.  The QC Scientist will execute Analytical Development activities, investigations, CCRs, CAPAs and  qualifications to ensure compliance based on regulatory and industry standards. 

Duties and Responsibilities:

  • Analytical Development to support the development, qualification, and validation of analytical methods for both small molecule drugs and biologic drugs.
  • Strong HPLC experience is desired, understanding chromatographic principals and applying knowledge to develop new methods and trouble shoot issues.
  • Experience with analytical characterization of small molecules and biologics is expected.
  • Experience with both small molecule drug substance and drug products, intermediates, as well as experience with monoclonal antibodies is desired.
  • Experience in biophysical characterization methods CE (capillary electrophoresis), chromatography, SEC/RP/IEX-U(H)PLC, SDS-CGE, iCIEF, CIEX, Peptide mapping, molecular testing required
  • Lead a group of scientists to perform analytical method development, optimization, qualification, leading to validation under cGMP in collaboration with the Quality Control unit
  • Apply expertise in molecular biology, cell biology and/or immunology to analytical development across the lifecycle of the procedures
  • Lead the technology transfer of analytical methods into QC and analytical method qualification
  • Method transfer, method validation, method development.
  • Serve as an analytical development SME to solve technical challenges
  • Lead projects / protocol testing that involves new methods and instrumentation.
  • Write, review & revise SOPs, reports, protocols & other appropriate documentation for lab Operations
  • Collaborate with other labs to prepare methods for transfer to the QC GMP labs

Qualifications:

  • Minimum of a B.S. (Biology, Biochemistry, Molecular, Chemistry, or related science) with 8+ years, M.S. with 5+ years, or PhD with 2+ years of relevant experience/education.
  • Strong organizational and time management skills. Clear ability to organize and prioritize work schedule to meet deadlines in an unknown environment with competing priorities.
  • Must be able to communicate effectively with managers and peers. Must possess ability to foresee and communicate bottlenecks that impede completion of tasks in a timely manner
  • Must demonstrate effectiveness in ability to train others as needed
  • Strong knowledge and expertise of quality requirements pertinent to pharmaceutical AD labs
  • Strong working knowledge of laboratory safety including standard precautions associated with hazardous & biohazardous material handling, Strong knowledge of AD analytical equipment and software Knowledge/understanding of 21 CFR part 11 is required.
  • Computer skills to include full competence with Microsoft Word, Power Point & Excel and LIMS is required.

 



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