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VTI Life Sciences (VTI)is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.

We are looking for a QC LaboratoryConsultant Manager for our client in the Great Boston, MA area. In this role you will oversee construction, setup and outfit of a new laboratory supporting gene therapy products. Assist in identifying analytical test instruments for procurement. Assist is development of laboratory policies, procedures and test methods following GMP and GLP. Implement quality laboratory processes that are compliant and efficient including scheduling, resource planning and technical related issues. Oversee the qualification of laboratory instruments and equipment, provide technical guidance and remediation for issues. Direct activities for the validation effort.

Education and Experience :

  • B.S. in Chemistry or related science plus 10 or more years experience in a pharmaceutical or biotech laboratory,
  • M.S. in Chemistry or related science plus 8 or more years experience in a pharmaceutical or biotech laboratory.
  • Minimum 5 years management experience in the pharmaceutical, biotech or analytical contract laboratory industries. Management experience should include direction of laboratory operations and implementation of process and system improvements
  • Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities

  • Knowledge, Skills and Abilities:

  • Full understanding of cGMP requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
  • Proven technical troubleshooting and problem solving abilities
  • Effective technical writing skills
  • Ability to manage multiple projects in the pharmaceutical industry or contract laboratory environment
  • Ability to implement quality systems and process improvements
  • Ability to provide guidance to clients on analytical issues and regulatory requirements
  • Ability to provide/coordinate technical training to support staff, as needed.
  • Biopharmaceutical as well asgene therapyanalytical experience is considered a plus
  • Experience or familiarity with toxicological safety data review is considered a plus
  • Supervisory skills in resource allocationand coordination of assignments is a plus.
  • Leadership skills especially interpersonal and communication skills
  • Proven ability to cope with a dynamic work environment
  • VTI Life Sciencesstrives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries.VTIoffers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

    As one of the leading global Commissioning, Qualification and Validation Services organizations,VTIis always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors.www.validation.org

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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