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.
Reporting to the 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 requirement
- Provide leadership, management and coaching to Microbiology team members
- Develop training requirements, ensure team members are adequately trained and qualified to perform the assigned job functions
- Plan, organize, and monitor the group’s activities ensuring they are in compliant with cGMP and that good documentation practices are followed
- Ensure QC microbiology equipment is qualified
- Lead the equipment maintenance program and ensure calibration status is maintained
- Draft, review, approve, and implement Standard Operating Procedures (SOP’s)
- Lead disinfectant efficacy test, method verification and validation according to appropriate guidelines, including drafting protocol and reports
- Establish and oversee all environmental monitoring and gowning qualification in support of aseptic manufacturing operations
- Compile, trend and interpret data from environmental monitoring
- Oversee water testing, materials, personnel and environment to detect microorganisms and to obtain information on types and levels of microbial contamination
- Develop procedure for and maintain library of environmental isolates from environmental monitoring program
- Review microbiology test results and the required contract microbiological testing of samples and manage the receipt of test results
- Provide expertise and technical leadership managing deviation, out-of-specifications (OOS)/out-of-trend (OOT) investigations, CAPA
- Report accurately and timely any risk, quality and compliance issues
- Support regulatory inspections
- Incorporate Corporate Polices and Compliance Standards into related microbiological procedures
- Perform other duties as required
KNOWLEDGE, SKILLS AND ABILITIES
- Degree in Microbiology or recognized qualification in microbiology
- Minimum 8 years of relevant work experience with 3+ years of supervisory experience in pharmaceutical or biological manufacturing industry
- Good working knowledge of GMP and regulatory requirements for products in major markets (such as FDA, EMA, HC, TGA)
- 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
- Excellent interpersonal (verbal and written) skills, detail oriented, organized and able to plan, schedule and oversee the execution of tasks by direct reports
- Work efficiently with the ability to innovate and identify creative solutions
- High proficiency in MS Word
- Strong scientific and technical writing skills
- Strong sense of pride in ownership and quality of work
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!