Chemist, Process Operations

Job Summary

The Chemist, Process Operations PO7ensures the safe and effective implementation and scale-up of process technologies complying with GMP and drug regulatory guidelines at Apotex Pharmachem Inc. The areas of responsibility include process characterisation and mapping, process implementation, process costing, root cause analysis and CAPA determination, process technology optimisation and scale-up.

Job Responsibilities

• Accountable for the safe and effective implementation, scale-up and operational optimisation of process technologies at Apotex Pharmachem Inc.
• Accountable for GMP and drug regulatory guideline compliance within the Process Operations Group throughout the implementation and commercialization of process technologies.
• Independently develops safe and effective implementation and scale-up plans of API manufacturing processes to achieve optimal process fit to pilot/production facility through detailed process mapping. Coordinate efforts of process implementation programs with R&D and RA/QA.
• Responsible for the timely preparation of GMP documentation as required. This includes (but is not limited to) Change Control Requests, Master Batch Records, supplemental batch instructions, deviation reports, validation documentation, annual product reviews, standard operating procedures, DMF supporting documentation.
• Prepares associated process documentation and provides to Production and Materials Management staff for batch execution. Ensure completion of process documentation as required for GMP compliance, in coordination with Quality Assurance.
• Ensures the completion the Process Operations component of HAZOP reports and coordinates with R&D and Engineering on the overall completion of HAZOP reports for new and existing processes.
• Responsible for real time completion of batch summary tables and process trending for pilot and commercial processes.
• Completes Corrective Actions and Preventative Actions investigations and ensures that the identified root cause and follow-up actions are appropriate and effective.
• Complete campaign summaries and evaluate campaign success with respect to campaign goals. Complete up-to-date costing analyses of assigned processes and critically evaluate production costs; identifies methods for cost reduction.
• Coordinates with Operations management, Production staff, Quality Control and Quality Assurance on scheduling priorities to meet production targets.
• Conducts on-the-floor monitoring of production in progress and provides guidance to production staff in the execution of pilot and commercial manufacturing processes. Conducts in-process testing as required.
• Troubleshoot problems encountered during new process piloting or routine production, and design experiments with R&D as necessary to investigate and resolve process related challenges.
• Systematically evaluate process performance data from batch records concurrently with batch production, develop and implement procedures to ensure consistent performance and identifies opportunities for improvement while complying with GMP and drug regulatory guidelines.
• Participate as required in the transfer of process technologies to contract manufacturing sites for assigned processes.
• 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

• Education
  • Bachelor degree in Chemistry or chemical engineering from a recognized academic institution
• Knowledge, Skills and Abilities
  • Proven computer literacy, particularly with the Microsoft Office suite of programs
  • Proven problem solving and trouble shooting skills
  • Ability to work independently and as a team member with demonstrated leadership skills.
  • Excellent oral and written communication skills.
  • Self-motivated, driven individual who is a results-oriented team player with effective interpersonal skills
• Experience
  • Minimum 3 years' experience as process chemist in a cGMP Active Pharmaceutical Ingredient (API) facility