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Senior Manager, QC Microbiology

Reference Number: 2834
Location: RI

Our client is a rapidly growing biopharmaceutical company.  They have asked us to assist them in their search for a Senior Manager, QC Microbiology.

The Senior Manager, QC Microbiology manages all sampling and testing programs for in-process, validation, release and stability samples for clinical and commercial products at our client’s manufacturing facility.  This includes bioburden, endotoxin, adventitious agent testing, TOC, microbial identifications and other related assays.

Major tasks and responsibilities will include:

  • Oversees projects including product specific qualifications, disinfectant efficacy studies, health authority commitments, expansions to MODA, etc.
  • Oversees department activities of 6-8 staff members supporting: Bioburden and endotoxin testing for raw materials, in-process, drug substance and drug product samples; validation samples including TOC and Biological Indicators.
  • Serves as back-up support for the environmental monitoring and critical utilities programs and microbial identifications.
  • Manages the identification, procurement and qualification of instruments and supplies of new pieces of equipment and maintenance of existing qualified equipment in support of QC Microbiology operations that support commercial and clinical manufacturing.
  • Manages budget for area of responsibility.
  • Establishes systems to maintain cGMP compliance in area of responsibility with regards to current SOPs, validation / qualifications, and training.  Represents QC Microbiology functions as required during audits by external agencies and auditors, as well as by internal auditors.
  • Serves as a Quality Control representative on cross-departmental task forces and committees as assigned, for example: change control, product / process/ raw material specifications, validation initiatives and product development plans.
  • Oversees laboratory investigations and reports in response to OOS, OOT, alert / action limits, etc.
  • Establishes systems across areas of responsibility to ensure compliance, good lab practices and efficiency.
  • Works with direct reports to develop performance objectives and personal development plans and to monitor performance against the objectives.
  • Reviews raw data, SOPs, protocols, policies and reports.
  • Manages / supports special projects as assigned.
  • Interacts with personnel within Manufacturing, Quality and other departments as required to meet objectives; interacts with business partners and technical representatives as required to meet objectives.
  • Represents QC Microbiology on Task Force or Planning Committees as assigned.  Provides QC Microbiology support to meet manufacturing schedules and changing priorities.

We seek candidates with the following qualifications:

  • Bachelor’s degree required; preference given to candidates with advanced degrees and degrees in Microbiology.
  • 8+ years of cGMP experience preferred; consideration will be given to other relevant experience and education.
  • Extensive knowledge / experience with QC Microbiology support of GMP pharmaceutical manufacturing.
  • Planning and organizing skills are required to plan, execute and manage resources against timelines and project commitments; must be able to adjust to changing priorities and a dynamic work environment.
  • Good interpersonal skills are required, as is the ability to communicate well, both verbally and written.
  • Competencies for this role include accountability, collaboration, decision quality, perseverance, problem solving, drive for results, informing, peer relations, and time management, developing direct reports, hiring and staffing, managing performance, and motivating others.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2834. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.