Chemist, Process Ii

**About Apotex Inc.**

**Job Summary**:
As the Process Chemist, II you will ensure the safe and effective implementation and scale-up of process technologies that comply with Good Manufacturing Practice (GMP) and drug regulatory guidelines throughout implementation and commercialization at our Apotex Pharmachem Inc location in Brantford. Your areas of responsibility will include process characterization and mapping, process implementation, process costing, root cause analysis and CAPA determination, process technology optimization and scale-up.

**Responsibilities**:

- Develop 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.
- Ensure timely preparation of GMP documentation including 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, Drug Master File (DMF) supporting documentation.
- Prepare associated process documentation for batch execution.
- Ensure the completion of the Process Operations component of the HAZOP reports and coordinate 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.
- Complete Corrective and Preventative Actions investigations to ensures that the identified root cause and follow-up actions are appropriate and effective.
- Complete campaign summaries and evaluate their success with respect to established goals.
- Complete up-to-date cost analysis of assigned processes and critically evaluate production costs as well as identify methods for cost reduction.
- Coordinate with key partners on scheduling priorities to meet production targets.
- Conduct on-the-floor monitoring of production in progress in addition to providing guidance to production staff in the execution of pilot and commercial manufacturing processes while conducting in-process testing as required.
- Troubleshoot problems encountered during new process piloting or routine production, and design experiments with R&D to investigate and resolve process related challenges.
- Evaluate process performance data systematically from batch records concurrently with batch production as well as develop and implement procedures to ensure consistent performance and identifies opportunities for improvement while complying with GMP and drug regulatory guidelines.
- Participate in the transfer of process technologies to contract manufacturing sites for assigned processes.

**Job Requirements**:

- 3 to 5 years of experience as a Process Chemist in a cGMP Active Pharmaceutical Ingredient (API) facility.
- Bachelor’s degree in Chemistry or equivalent education.
- Proven problem solving and trouble shooting skills.
- Excellent oral, communication, and technical writing skills.
- Self-motivated, driven individual who is a results-oriented team player with effective interpersonal skills who can work independently with demonstrated leadership skills.
- Proven computer literacy, particularly with the Microsoft Office suite of programs.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.

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.