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Manager, Quality Control (Microbiology)

Location
Burnaby, BC
Details
Full Time
14 days ago

ABOUT THE COMPANY

New Beta Innovation Canada Limited (NBI) is a preclinical stage life sciences organization in Burnaby, BC. Leveraging on our expertise in research and development, we are transforming drug discovery into clinical applications for unmet medical needs. We have ongoing collaborations with top universities worldwide on various research projects, with distinguished achievements in the areas of oncology, neurology, ischemic and hypoxic conditions.

Our state-of-the-art GMP manufacturing facilities and laboratories in Greater Vancouver are home to a growing team of professionals who are inspired to develop advanced life-saving hemoglobin-based therapeutics for the well-being of people.

POSITION OVERVIEW

Reporting to the Senior Manager, Quality Control the incumbent will perform a variety of microbiological related functions and will provide leadership to the team responsible for ensuring the integrity of the microbiology laboratory in support of a sterile pharmaceutical manufacturer.

KEY RESPONSIBILITIES

  • Be part of the QC management team to set department objectives and priorities
  • Establish and oversee all environmental monitoring and microbiology lab related activities
  • Plan, schedule and oversee microbiological testing, activities and reports
  • Compile, trend and interpret data for release and environmental monitoring testing
  • Lead method verification and validation activities by authoring and/or reviewing protocols, coordinating testing, and reviewing reports according to appropriate guidelines
  • Draft, review and implement Standard Operating Procedures (SOP) in the microbiology laboratory
  • Oversee QC equipment to ensure qualification and calibration
  • Participate and/or lead investigations with strong understanding of compliance and GMP, strong scientific judgment and leadership in decision making
  • Provide expertise and technical leadership managing deviations, investigations, OOS, CAPAs, change requests, and improvement initiatives for the microbiological team
  • Lead continuous improvement activities related to Quality Control and compliance
  • Support regulatory activities including, but not limited to, regulatory inspections and filings as applicable
  • Perform other duties as required

KNOWLEDGE, SKILLS AND ABILITIES

  • Degree in Microbiology or recognised qualification in microbiology required
  • Minimum 6 years of relevant work experience in pharmaceutical or biological manufacturing industry with more than 2 years managing a team
  • Good working knowledge of aseptic techniques and good documentation practices
  • Have strong working knowledge of GMP, ICH, PIC/S, etc.
  • Have experience with execution of USP and Ph. Eur. test methodologies (e.g. bioburden, endotoxins, sterility, growth promotion) used for the testing of sterile products
  • Experience in method verification, validation and transfer
  • Must be able to gown as required for access into cleanroom areas
  • Sound judgement to identify and address issues 
  • Excellent interpersonal (verbal and written) skills, detail oriented, organized and able to plan, schedule and oversee the execution of tasks by direct reports
  • Ability to problem solve with sound analytical thinking
  • Strong sense of pride in ownership and quality of work
  • Experience working in a start-up environment would be an asset

WHY JOIN NBI?

The best reason is because of our wonderful people and great work environment. If you are looking for a career with meaning and purpose, it’s hard to beat working in life sciences. We provide an attractive compensation and benefits package which recognizes people for their contributions, and comprehensive training and career development opportunities which support our employees’ growth with the company.

If you are interested in joining our team, we encourage you to APPLY today!

Category
Biotechnology