Manager, Production (Process) (BB-9B8FB)
Found in: Neuvoo CA
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, Production, the incumbent will lead the manufacturing process activities and will be responsible for ensuring the integrity of quality as it relates to process and product.
The incumbent will need to be flexible with their work hours and schedule, may be required to perform shiftwork to fulfil manufacturing requirements. Pre-employment medical and annual medical examination may be required to fulfil regulatory requirements.
- Lead and develop Process team members
- Plan, organize, and monitor manufacturing activities in accordance with cGMP
- Ensure that products are produced and stored in accordance to required standards and regulatory requirements
- Facilitate effective technical transfer of manufacturing process from corporate to site
- Ensure alignment with corporate regarding quality systems, policies, procedures and standards
- Ensure site manufacturing comply with regulatory commitments in NBI dossiers per CMC section of marketing applications
- Develop and approve the instructions and SOPs relating to production operations according to corporate and regulatory requirements and ensure their strict implementation
- Ensure that the production records are evaluated and signed by a designated person
- Ensure company’s QMS is effectively implemented and followed
- Ensure timely and effective communication of risks, quality or compliance issues to appropriate personnel
- Maintain facilities and equipment in accordance with cGMP standards and requirements (including calibration, process and cleaning validation)
- Support 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 QA section
- Manage the procurement of starting material, packaging material and consumables
- Manage and coordinate process development and scale-up development work as required
- Plan and execute department schedules including production and packaging, facility cleaning and disinfection
- Approve purchasing activities in relation to production and packaging processes
- Be accountable for daily recaps of all production variances and establishing KPIs for the shift supervisors to ensure continuous improvement of financial objectives
- Develop, recommend, and implement measures to improve productivity and maximize efficiency
- Be present on the production floor as required
- Prepare and manage targets for Safety, First Time Quality, raw material yield, labor, and packaging materials usage, and maintain budgetary expenses, commensurate with ongoing business volumes
- Perform other duties as required
KNOWLEDGE, SKILLS AND EXPERIENCE
- Degree in pharmaceutical, biotechnology, biochemical engineering or equivalent life sciences discipline is a must
- Minimum 8 years downstream processing experience in biological manufacturing industry with 3+ years of supervisory 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
- Ability to effectively prioritize and manage competing tasks and projects
- Strong problem solving and decision-making skills
- Strong attention to detail and time management
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!
calendar_today20 hours ago
work New Beta Innovation Canada Limited