Associate Director, Bioanalysis

2 months ago

Germantown, United States Pharmaron Full time
Job DescriptionJob Description

Pharmaron is searching for a leader to join their team in Germantown, MD. If you're craving a role that offers challenges, growth, and provides a meaningful impact, then this is the opportunity you've been waiting for.

Job Overview:

The Associate Director, Bioanalysis & Biomarker, will be responsible for regulatory compliance and accreditation, strategic planning, budgeting, quality assurance, provider relations, and creating an environment conducive to efficient daily operations.

Additional Duties:

  • Establish the strategic goals and objectives, plan, staff, direct activities, and assure operational and financial effectiveness for the LC-MS Bioanalysis Laboratory.
  • Responsible for direction and coordination of LC-MS Bioanalysis personnel.
  • Creates and conducts quality assurance and control procedures for specimen processing.
  • Identify the need for policy development and/or revision, defines policies in collaboration with higher level management input, goals and objectives.
  • Develop, monitors and revises functional processes.
  • Maintain performance improvement activities within the department and participates in quality improvement activities.
  • Ensure that laboratory is in compliance with regulatory and licensing agencies.
  • Provide input into the development and revision of organizational structure for function or service for the LC-MS Bioanalysis laboratory.
  • Ensure the timely completion of performance appraisals.
  • Assist in development of and monitors budget for a major function, multiple units/areas, or processes.
  • Select and implement new laboratory instruments, testing methods and reagents.
  • Collaborate with research sponsors to develop and implement new laboratory services that are required by their protocol.
  • Develop and implement laboratory staff technical training programs and competency tests.
  • Provide the laboratory staff with study-specific training
  • Create and conduct Quality Assurance and Quality Control activities to ensure laboratory instruments are properly maintained and functioning appropriately, quality control material is run as describe in the technical SOP, and that the control material is given the correct results:
    • test reagents are functioning as expected;
    • test results are accurate
    • testing methods are appropriate
    • specimen processing is done as describe in the protocols and
    • samples are stored and shipped as described in the protocol or in the protocol-specific lab manual.
  • Develop and maintain an accurate price listing for laboratory services.
  • Assist the Business Development Department with the review of new proposals to outline the laboratory capabilities.
  • Promote a safe laboratory environment for personnel and other occupants.

What we are looking for:

We are seeking individuals with industry experience working at and with CRO's and CDMO's.

Qualifications and Experience:

  • PhD in relevant field plus at least 10 years of related experience OR Masters in relevant field plus at least 12 years related experience; OR Bachelors in relevant field with at least 15 years related experience.
  • Experience working in a CRO is preferred.
  • Experience working with LC-MS large molecule bioanalysis is preferred.

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