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New Beta Innovation Canada Limited: Manager, Production (Process)

New Beta Innovation Canada Limited

This is a Contract position in Barrie, ON posted February 8, 2021.

ABOUT THE COMPANYNew 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.POSITION OVERVIEWReporting 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.KEY RESPONSIBILITIESLead and develop Process team membersPlan, organize, and monitor manufacturing activities in accordance with cGMPEnsure that products are produced and stored in accordance to required standards and regulatory requirementsFacilitate effective technical transfer of manufacturing process from corporate to siteEnsure alignment with corporate regarding quality systems, policies, procedures and standardsEnsure site manufacturing comply with regulatory commitments in NBI dossiers per CMC section of marketing applicationsDevelop and approve the instructions and SOPs relating to production operations according to corporate and regulatory requirements and ensure their strict implementationEnsure that the production records are evaluated and signed by a designated personEnsure company’s QMS is effectively implemented and followedEnsure timely and effective communication of risks, quality or compliance issues to appropriate personnelMaintain 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 qualityProvide support and participate in material supplier qualification and contract manufacturers qualification activities as deemed necessary by QA sectionManage the procurement of starting material, packaging material and consumablesManage and coordinate process development and scale-up development work as requiredPlan and execute department schedules including production and packaging, facility cleaning and disinfectionApprove purchasing activities in relation to production and packaging processesBe accountable for daily recaps of all production variances and establishing KPIs for the shift supervisors to ensure continuous improvement of financial objectivesDevelop, recommend, and implement measures to improve productivity and maximize efficiencyBe present on the production floor as requiredPrepare and manage targets for Safety, First Time Quality, raw material yield, labor, and packaging materials usage, and maintain budgetary expenses, commensurate with ongoing business volumesPerform other duties as requiredKNOWLEDGE, SKILLS AND EXPERIENCEDegree in pharmaceutical, biotechnology, biochemical engineering or equivalent life sciences discipline is a mustMinimum 8 years downstream processing experience in biological manufacturing industry with 3 years of supervisory experienceKnowledge with aseptic processing is a mustGood 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 environmentWork efficiently with the ability to be innovative and identify creative solutionsHigh proficiency in MS Word and good writing skillsStrong sense of pride in ownership and quality of workAbility to effectively prioritize and manage competing tasks and projectsStrong problem solving and decision-making skillsStrong attention to detail and time managementWHY 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