Group Leader - Quality & Analytical

Cambridge, MA

Posted: 06/13/2019 Industry: Laboratory - Industrial Chemicals Job Number: 264.19TM Pay Rate: 125,000

**Only applicants who are legally authorized to work in the United States will be considered**

Director - Quality & Analytical

This highly cross-functional role will be responsible to ensure batch-to-batch quality of haircare products and raw materials and directs method development activities for new products and research.  This role will also manage the EH&S function for the company.

The qualified individual will report to the VP of Research and will provide leadership for multiple hands-on projects and facilitate team interactions among a diverse group of scientists within company’s Product Development, Discovery, and Packaging Development teams.  Successful integration with the Supply Chain Regulatory, and Sales functions will also be essential for this role.

Key Responsibilities

Analytical:

  • Directs method development, validation, remediation and continuous improvement plans for all analytical assays
  • Technical subject matter expert in analytical chemistry, supporting cross-functional R&D New Product Development
  • Scientifically advises R&D team on methods for HPLC, GCMS, GPC, and FTIR
  • Directs raw material and formulation chemical stability program for proprietary ingredients
  • Ensures product safety through managing a residuals testing program
  • Facilitates purchase, installation, and validation of new analytical instrumentation based on business need
  • Manages preventative maintenance program for lab instrumentation

Quality:

  • Manages a QA/QC program to support 50+ commercial products. Directs QC release testing, investigations, and root cause analyses; conducts data reviews and trending analyses with 3rd party manufacturers
  • Authors, implements, and trains on quality SOPs, review and approve technical reports, safety data sheets, and test methods
  • Authors and executes quality agreements; performs documentation and facility audits of 3rd party manufacturers and warehouses
  • Manages testing with CROs, international scale-up partners, and academic collaborators
  • Develops effective and efficient processes to manage consumer complaints, and undesired events, with routine reporting to senior management

Environmental Health & Safety:

  • Act as a Safety Committee Chair and Chemical Hygiene Officer. Interacts strongly with Office Manager / Emergency Coordinator to maintain lab and facility safety
  • Manages hazardous shipping program (49CFR and IATA DGR trained)
  • Directs lab safety and hazardous waste program (DOT and RCRA trained)
  • Maintains facility permits (flammable, wastewater, etc.)

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Tory Mack at 815.756.1221 / tmack@cps4jobs.com.

JO:  264.19TM
#LI-TM1

**Only applicants who are legally authorized to work in the United States will be considered**

Requirements:

  • A degree in Chemistry, Biochemistry, Engineering or closely related field. MS with 10 years, or PhD with 7 years of relevant industry experience
  • Certification in a quality role (CQE, Six Sigma Green/Black Belt, or similar) or proven track record of connecting multi-functional teams, projects, and processes in a quality function
  • Experience working a GMP/GLP/ISO9001 environment and knowledge of relevant regulatory guidelines (FDA, ICH, ISO, REACH, etc.)
  • 3-5 years managing a team of quality control or analytical development scientists
  • 3-5 years of laboratory experience in Mass Spectrometry or Chromatography
  • HPLC, GCMS, GPC, FTIR – instrumentation and method development experience. Some methods are already in place, some they transfer to CMOs, and with new products this person will need to develop methods.  SEM, TEM, and NMR are all nice to have
  • Extensive experimental design experience, proven problem-solving skills, and strong critical thinking ability

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Tory Mack at 815.756.1221 / tmack@cps4jobs.com.

JO:  264.19TM
#LI-TM1

 

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