Apotex Pharmachem Inc. (CAN_API)
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D;, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc.
fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.
As a seasoned member of the Process Support Group, utilizes prior knowledge and experience gained to act as an on-shift extension of the process operations group supporting pilot and commercial processes at Apotex Pharmachem Inc. The areas of responsibility include in-process testing as well as monitoring and troubleshooting production and pilot processes as well as manufacturing operations.
PLEASE NOTE: THIS ROLE IS LOCATED IN BRANTFORD, ONTARIO
Accountable for execution and interpretation of assigned in-process testing for pilot and commercial processes
Accountable for GMP and drug regulatory guideline compliance
Monitor the execution of pilot and commercial manufacturing processes during production shift on behalf of the Process Designate
Provide guidance to production personnel pertaining to execution of pilot commercial manufacturing processes,taking guidance from Process Designate
Under direction of Process Designate assist in trouble shooting process related challenges during production shift provide summary of findings for review and further decisions and actions
Under direction of Process Support Supervisor and Process Designate conduct experiments to support manufacturing operations.The scope of experiments may include process troubleshooting and investigation test of raw materials,second crop,solvent recovery and experiments relating to commercial process optimizations
Responsible for real time completion of batch summary tables, process trending where required,for pilot and commercial processes
Complete end of shift production update summary which detail status of active processes in manufacturing,relevant batch data (IPC results CPP execution data) major or critical deviations and circulates this summary electronically to Process Group as well as Management
Assist production personnel with execution of new manufacturing processes with use of new equipment as per process requirements following instructions from the Process Designate
Assist with the shift-to-shift plant-status technology transfer
Perform designated in-process, informational testing analyses, interprets the results i.e.Thin Layer Chromatography,Nuclear Magnetic Resonance Spectroscopy others as required,seek support in interpretation/execution from Process Designate
Responsible for alerting Process Designate w.r.t. any OOS/OOT result on IPT's and Critical Process Parameters as soon as they occur and relay necessary instructions to production for implementation of the measures identified
Alert the Process Designate of any major/critical process deviations and coordinate the implementation of corrective measures identified and necessary process documentation
Provide guidance and training to Process Support Chemists,Chemical Engineering,Technicians working in the group.
Coordinate activities with Chemical Engineering, Technicians, Process Support Chemists with direction from Process Support Supervisor and/or Supply Operations Management,ensuring departmental project goals are met in a timely manner
Meet all deadlines associated with projects as directed, including all reports and documentation
Effectively contribute in investigation/troubleshooting of Manufacturing related issues and/or optimizations-added manufacturing as they can also work with operations/equipment, improvements, etc
Communicate to the Process Designate relevant information regarding process performance during their shift
Knowledgeable in and follow GMP's and conform with relevant departmental and other company standard operating and safety procedures
Ensure continuous professional development by regular literature review
Conduct oneself in a respectful and professional manner both internally and externally adhering to Company policies and procedures
Work independently or as part of a team fostering positive working relationship with team members as well as positive working environment between Process Operations and other departments
Perform all work in support of Corporate Values of Passion, Perseverance, Collaboration and Courage; Demonstrates strong and visible support of our values
Perform all work in accordance with all established regulatory, compliance and safety requirements
Additional responsibilities as assigned
Bachelor degree in Chemistry with a background in Organic Chemistry or equivalent and experience in API manufacturing
Minimum 2 years in the position of Process Support Chemist I or equivalent experience
Previous experience or education pertaining to the execution and interpretation of Nuclear
Magnetic Resonance Spectroscopy and Thin Layer Chromatography - preferred
Knowledge, Skills and Abilities:
Proven computer skills, particularly with the Microsoft Office suite of programs
Proven problem solving and trouble shooting skills
Demonstrated ability to work independently or as a team member
Excellent oral and written communication skills.
Self-motivated, driven individual who is a results-oriented team player with effective interpersonal skills.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex 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.