Operational Excellence Specialist, Production

New Beta Innovation Canada Limited

Location

Burnaby, BC

Details

Full Time

4 days ago

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

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

Knowledge, Skills and Experience

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

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!

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About New Beta Innovation Canada Limited

New B Innovation (NBI) is a dedicated player in the global biotechnology market with a vision to advance life sciences and health care using the latest technologies and innovative approaches to del...