ABOUT THE COMPANY
New Beta Innovation Canada Limited (NBI-CA) 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.
Reporting to the Manager/Senior Manager, Quality Control (QC), the incumbent will perform a variety of microbiological lab related functions and will lead the Microbiology team. The incumbent is responsible for ensuring the integrity of the laboratory in support of a sterile pharmaceutical manufacturing facility.
The incumbent will need to be flexible with their work hours and schedule, and may be required to perform shiftwork to fulfil manufacturing requirements. Pre-employment medical and medical re-examination may be required annually to fulfil regulatory requirements.
- Establish and oversee all environmental and microbiology related programs
- Plan and prioritize microbiological testing activities and provide leadership to the Microbiology team.
- Compile, trend and interpret data for release and environmental monitoring testing
- Support method verification and validation activities by authoring and/or reviewing - protocols, coordinating testing, and reviewing reports according to appropriate guidelines
- Ensure Quality Control equipment is qualified and calibration status is maintained
- Participate and/or lead investigations with strong understanding of compliance and cGMPs, strong scientific judgment and leadership in decision making
- Provide expertise and technical leadership managing deviations, investigations, OOS, CAPAs, change requests, and improvement initiatives within the microbiological team’s remit
- Support continuous improvement activities related to Quality Control and compliance
- Support regulatory activities including, but not limited to, regulatory inspections and filings related to general analytical methodologies
- Work collaboratively with the QC management team to discuss department objectives and planning strategies
- Perform other duties as assigned
KNOWLEDGE, SKILLS AND ABILITIES
- Degree/Masters’ Degree in Microbiology or recognised qualification in microbiology required
- Minimum 6 years or more 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 working knowledge of US and EU Good Manufacturing Practices (GMPs) and other international GMP standards such as ICH, PIC/S
- Have experience with execution of USP and EP test methodology (Microbial, Sterility, Endotoxin, Growth Promotion) for the manufacture of sterile products and design and implementation of environmental monitoring programs
- Understanding of 5S methodology and able to transform an area using 5S methodology
- Experience in analytical method verification, validation and transfer
- Must be able to gown as required in manufacturing areas
- Sound judgement to identify when an issue needs to be escalated to management
- Excellent interpersonal (verbal and written) skills, detail oriented and organized and methodical in planning, scheduling and execution of tasks
- 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.