Sr Manager, QC And Analytical Operations

Location
San Francisco, CA
Posted
May 22, 2019
Required Education
Bachelors Degree
Position Type
Full time

Vir Bio is seeking an experienced QC and Analytical Operations Manager to build, manage, and maintain Vir’s internal Quality Control and Analytical Services laboratories. In this role you will have the exciting and unique opportunity to build and manage QC testing and analytical services to support clinical development activities across multiple drug modalities. This is a high-profile role that will provide analytical testing services for Process Development, Analytical Development, and Quality Control.

RESPONSIBILITIES:

  • Develop, implement, and manage Vir’s internal QC testing laboratories and the Raw Materials Management group. This includes sample testing (starting materials, API, Intermediates, and Drug Product) to support process development and early phase lot release, as well as the development and oversight of raw material and critical reagent programs.
  • Create a strategic vision and roadmap for how the QC Operations group will continually evolve to meet the needs of Vir’s innovative, multi-modality business model.
  • Set up QC lab infrastructure and systems including but not limited to QC sample management, management of QC controlled inventory, scheduling, training, reporting of results, and data management.
  • Build and manage a team of QC personnel responsible for the execution of analytical testing activities to support release and stability testing, process analytics, and critical reagent qualification. Train and mentor staff conduct performance reviews and create employee development plans.
  • Review release and stability data. Generate and approve certificates of testing, certificates of analysis, and stability reports.
  • Manage deviations, laboratory investigations, OOS, and changes per internal procedures.
  • Collaborate with QA and QC colleagues on development of performance metrics and product quality assessments, as needed.
  • Periodically assess and confirm the phase appropriate compliance levels of Vir’s QC testing lab in collaboration with QA.
  • Collaborate with QA and provide on-site support during inspections as needed.

QUALIFICATIONS AND EXPERIENCE:

  • Desire and proven ability to manage junior staff; strong leadership skills are essential.
  • Knowledge of regional and international testing requirements with experience developing strategies for release and stability testing of drug products.
  • Experience developing and authoring procedures to support QC systems, reviewing analytical data for compliance with GMPs, and reporting data to external partners. Startup experience preferred.
  • Demonstrated knowledge of cGMP/ICH/FDA/EU regulations, as well as USP, EP, and JP monographs.
  • Refined critical thinking skills, with an emphasis on flexibility and risk-based, phase-appropriate approaches to problem-solving.
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders. Experience collaborating with and supporting Process and Analytical Development is a plus.
  • Excellent organizational, analytical, and communications skills.
  • Self-directed individual who can work independently in a fast-paced, goal-oriented environment.

EDUCATION:

  • Bachelor’s degree in a scientific discipline (chemistry or biology focus preferred) or other relevant degree.
  • 10+ years of experience managing a QC or analytical laboratory in the biopharmaceutical industry.