Operational Excellence Specialist, Production (New Beta Innovation Canada Limited)

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.

Position Overview

Reporting to the Manager, Production, the incumbent will be responsible for leading the implementation and sustaining of the operational excellence in the PD team. The incumbent will look for improvements and ensure compliance within the PD Team, by reducing the risks that can lead to non-adherence of planning or inefficiencies.

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.

Key Responsibilities

• Develop and coordinate studies related to critical deviations or necessary improvements or changes
• Monitor the results of quality control analyses and environmental monitoring, from the verification of the results of analysis reports, aiming to ensure product quality
• Immediately report to manager any conditions or deviations (relating to plant, equipment, personnel or any health condition) that may adversely affect the products and participates in investigation process
• Participate in the operationalization and discussion of TT's (technology transfer) and process improvement projects to coordinate actions with the appropriate project/process owners to accomplish goals
• Perform other duties as required
• Develop and follow up with stakeholders on progress/projects related to cleaning and process validation and periodic product reviews
• Support production managers and act as first point of contact when a manager is absent or out of the office
• Evaluate potential impacts on schedules, caused by events which cannot be predicted in advance and act to minimize or annul negative impacts
• Develop, monitor, and analyze production KPIs to drive behaviour and improvements
• Assess the short/medium/long term risks for the proposed schedules from a compliance perspective
• Takes initiative to understand the market and industry best practices to update policies, projects, routines, and procedures related to PD
• Develop, implement, and monitor the control charts
• Provide guidance, instructions, feedback, and training to other team members
• Act as a change agent to lead team members in the engagement and sustainment of a continuous improvement culture
• Ensure strict implementation of company safety policies, SOPs and GMP regulations in PD
• Provide guidance, support, and monitoring of department activities, while aiming to ensure the effectiveness of the production processes
• Support the transfer of technical knowledge to the PD teams on specific topics
• Support the immediate manager in the development, implementation, maintenance, and reorganization of programs and special projects, through research and studies, adjusting standards and procedures
• Perform evaluation on critical deviations, investigations, CAPAs, and Change controls
• Conduct assessments related to effectiveness and productivity, finding opportunities for improvement
• Contribute to the excellence of services, based on the commitment to the principles and concepts of quality
• Collaborate in national (internal and external) and international inspections and take ownership of the completion of observations/deviations
• Act as Manufacturing Subject Matter Expert to provide information and collaborate with other departments

Knowledge, Skills And Experience

• A self-starter with ability to take initiative, learn quickly, and think independently
• Previous experience of Lean/ Six sigma/ Kaizen (or other improvement processes) or Certification
• Strong interpersonal skills and ability to work effectively in a team
• Proven record of implementing and inspiring continuous improvement culture in an organization
• Post-secondary degree in Pharmaceutical Science, Biology, Biochemistry, Biotechnology, Applied Biology or equivalent related to the responsibilities
• Integrated vision between Quality and Production with strong sense of pride in ownership
• Strong communication, collaboration, facilitation, and influencing skills with ability to interact across all operation teams and at all levels of the organization
• Good working knowledge of GMP and regulatory requirements for products in major markets
• Minimum 5 years of experience working in a pharmaceutical area, cGMP processing environment and/or combination of education and experience
• Strong problem solving and decision-making skills
• Results oriented with the ability to effectively prioritize and manage multiple tasks and projects
• Knowledge of KPIs and Pharmaceutical applied statistics will be an asset
• Flexible and adaptable to changing circumstance and challenges

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!

Value