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 NBI-CA Director, and liaison with Head Office Production Management, the incumbent shall be accountable for the overall management of the Production department and responsible for ensuring compliance of all regulatory requirements and the integrity of quality as it relates to process and product.
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.
- Manage all production related plan programs and team activities to meet tight targets and schedule
- Develop and/or monitor Key Performance Indicators and determine overall manufacturing support including team resource and equipment planning to meet production schedules
- Responsible for the performance management, professional growth and development of the team
- Lead, manage and coach Production team with high level of engagement and achievement
- Ensure budgets, schedules and performance requirements are met and delivered on time/in full and at the right cost
- Responsible for leading improvements from end-to-end of production line
- Responsible for all aspects of GMP production ensuring products meet production schedule, quality standards and regulatory compliance
- Ensure that products are produced and stored according to the appropriate documentation or procedure in order to obtain the required quality
- Ensure quality systems are aligned with corporate to enable a common approach of quality initiatives/knowledge sharing and strengthen NBI global regulatory compliance
- Ensure site manufacturing comply with regulatory commitments in NBI dossiers per CMC section of marketing applications
- Implement consistent and accurate reporting of potential risks and quality or compliance issues to corporate management
- Develop and approve the instructions and SOPs relating to production operations according to corporate and regulatory requirements and ensure their strict implementation
- Ensure company’s Quality Management System (QMS) is effectively implemented and followed
- Ensure timely and effective communication of quality issues to the site Qualified Person (QP), Quality Assurance management (QA) and escalation to corporate management
- Participate in management reviews of process performance, product quality and advocating continual improvement
- Participate in the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality
- Provide support and participate in material supplier qualification and contract manufacturers qualification activities as deemed necessary by Quality Assurance
- Perform other duties as required
Knowledge, Skills and Experience
- Degree in pharmaceutical, biotechnology, biochemical engineering or equivalent life sciences discipline. The degree should be issued by a Canadian university or recognized by a Canadian university or Canadian accreditation body
- 10+ years relevant hands on downstream processing experience in biological manufacturing industry with a minimum of 5+ years of managerial experience
- Knowledge with aseptic processing is a must
- Good working knowledge of GMP and regulatory requirements for products in major markets (such as FDA, EMA, HC, TGA)
- Excellent interpersonal skills, ability to work independently and in a team environment
- Work efficiently with the ability to be innovative and identify creative solutions
- High proficiency in MS Word and good writing skills
- Strong sense of pride in ownership and quality of work
- Flexible and adaptable to changing circumstance and challenges
- Ability to strategize, and implement department plans
- Ability to effectively problem solve, manage resources and work under pressure to maintain continuous operations
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!