Senior Manager, Production / New Beta Innovation | Eluta.ca

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Develop and/or monitor Key Performance Indicators and determine overall manufacturing support including team resource and equipment planning to meet production schedules

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Responsible for the performance management, professional growth and development of the team

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Lead, manage and coach Production team with high level of engagement and achievement

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Ensure budgets, schedules and performance requirements are met and delivered on time/in full and at the right cost

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Responsible for leading improvements from end-to-end of production line

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Responsible for all aspects of GMP production ensuring products meet production schedule, quality standards and regulatory compliance

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Ensure that products are produced and stored according to the appropriate documentation or procedure in order to obtain the required quality

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Ensure quality systems are aligned with corporate to enable a common approach of quality initiatives/knowledge sharing and strengthen NBI global regulatory compliance

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Ensure site manufacturing comply with regulatory commitments in NBI dossiers per CMC section of marketing applications

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Implement consistent and accurate reporting of potential risks and quality or compliance issues to corporate management

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Develop and approve the instructions and SOPs relating to production operations according to corporate and regulatory requirements and ensure their strict implementation

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Ensure company’s Quality Management System (QMS) is effectively implemented and followed

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Ensure timely and effective communication of quality issues to the site Qualified Person (QP), Quality Assurance management (QA) and escalation to corporate management

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Participate in management reviews of process performance, product quality and advocating continual improvement

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Participate in the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality

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Provide support and participate in material supplier qualification and contract manufacturers qualification activities as deemed necessary by Quality Assurance  

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Perform other duties as required

2. Knowledge, Skills and Experience

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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

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10+ years relevant hands on downstream processing experience in biological manufacturing industry with a minimum of 5+ years of managerial experience

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Knowledge with aseptic processing is a must

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Good working knowledge of GMP and regulatory requirements for products in major markets (such as FDA, EMA, HC, TGA) 

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Excellent interpersonal skills, ability to work independently and in a team environment 

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Work efficiently with the ability to be innovative and identify creative solutions

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High proficiency in MS Word and good writing skills

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Strong sense of pride in ownership and quality of work

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Flexible and adaptable to changing circumstance and challenges

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Ability to strategize, and implement department plans

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Ability to effectively problem solve, manage resources and work under pressure to maintain continuous operations