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Technical Chemistry Manufacturing and Controls Coordinator

Date: Oct 15, 2021

Location: North York, ON, CA, M9L 2Z7

Company: Apotex

 

Apobiologix, a division of Apotex Inc., is a global biopharmaceutical company focused on development and distribution of biosimilars that combine quality and value with comprehensive support for patients with life-threatening diseases.  With an integrated global commercial strategy and a pipeline of biosimilars, Apobiologix is well positioned for leadership in the biosimilars industry.

Job Summary

 

Apobiologix is a division of Apotex that works closely and in-depth with multiple global vendors in a virtual environment to deliver biopharmaceutical projects from inception to commercialization by co-development or in-licensing. 

As an Apobiologix team member, provide Apobiologix division with technical support for Chemistry Manufacturing and Controls (CMC) related activities for biopharmaceuticals in the pipeline according to national and international regulatory expectations. Provide technical support for life cycle management activities for the commercial products, interacting closely with the Global Quality and Regulatory teams that support Apobiologix.

Job Responsibilities

 

  • Provide technical support for Apobiologix commercial products’ life cycle management (PLCM) activities including, but not limited to change control processes and regulatory submissions. Act as CMC SME as required and interact effectively with QA and RA as part of cross-functional teams.
  • Review and assess change control documents from Contract Manufacturing Organisations, or Contract Development and Manufacturing Organisations (third parties) for accuracy and completeness of technical information provided. Also review and ensure that all documents that are required to support the proposed changes are provided. Act independently as technical lead for change control process as appropriate.
  • Review and identify gaps in technical information provided with new change controlsto ensure smooth and efficient initiation in the Quality Management System. Liase with third party partners to close information gaps.
  • Coordinate and contribute to the planning, execution and monitoring of activites related to the CMC of new and existing Apobiologix products, such as method development, validation for release, stability testing of characterisation, biosimilarity studies, tech transfers and device changes.
  • Coordinate,review and revise, as necessary, the Quality and CMC sections of Common Technical Documents (CTDs), relating to analytical methods development, qualification, validation, characterization and biosimilarity studies for Apobiologix projects.
  • Coordinate cross-functional activites related to the CMC or PLCM of Apobiologix projects such as tracking, monitoring and reporting on status of change controls, and develop project management tools to support those activities, as required. Lead cross-functional project team meetings. Facilitate agendas, takes minutes and records actions, as needed.
  • Identify and communicate any gaps, risks or issues promptly and works to resolve them in a timely manner. Escalate appropriately.
  • Responsible and accountable for compliance with all aspects of the Ontario Occupational Health and Safety Act, as well as Apotex’s Health and Safety policies, Safe Work Procedures (SWPs) and Safety Charter.
  • Participation in other technical assignments and internal projects as needed.
  • Works in a safe manner collaborating as a team member to achieve all outcomes.
  • Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
  • Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  • All other relevant duties as assigned.

 

Job Requirements

 

  • Masters degree in Biochemistry, Biotechnology or analytical chemistry or related fields
  • 5+ years of technical experience in biopharmaceuticals analysis and / or manufacturing in a regulated biopharmaceutical environment
  • Experience with Quality Management System (like Trackwise) will be an asset
  • Broad understanding of biopharmaceuticals manufacturing and in-depth knowledge of biochemistry and protein analytical chemistry as applied to CMC related aspects of biopharmaceutical development.
  • Knowledge of and practical experience with national and international regulatory requirements as they relate to the manufacture and analysis of biopharmaceutical drugs in compliance with current Compendia, Pharmacopoeia, ICH and GMP requirements.
  • Should be highly organized, excellent attention to details and have ability to multitask when needed
  • Demonstrated proficiency in written and verbal English communication.
  • Demonstrates necessary interpersonal skills to effectively and efficiently work collaboratively with a broad range of colleagues, international partners and vendors.


 

 

 

At Apobiologix, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.  Apobiologix offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.