Scientific Leader Liquid Manufacturing

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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Job Summary

Responsible for the supervision of and providing assistance with technical support projects for the improvement of new and current product formulations and processes launch and demonstration batches to ensure the manufacture of high-quality products and the use of efficient manufacturing processes at all Apotex sites.

Technical Support Services works closely with Procurement Planning Manufacturing Quality and R&D in order to ensure that products are restored in a timely manner to routine manufacture in a safe compliant and efficient state. Technical Support Services also evaluates changes to or new sources of Active Pharmaceutical Ingredients (APIs) and excipients for use in the manufacture of existing commercial pharmaceutical products.

Coach and support other Scientific Leaders and Supervisors at the site and across sites to maintain a consistent approach to problem solving and continuous improvement of commercial products.

Job Responsibilities

• Investigates formulation and process deficiencies for current products being manufactured in order to determine the causes and to recommend and implement solutions for improvement.
• Develops recommends and provides technical support to experimental trials in order to evaluate changes in formulations raw materials and manufacturing processes.
• Monitors and supervises the full-scale manufacture of products as required to provide technical support and / or technology transfer to the manufacturing departments.
• Writes investigational reports project summaries project updates and provides recommendations as required.
• Screens and evaluates data (e.g. Dissolution assay and content uniformity) on trials and makes recommendations for stability batches reprocessing rework and batch failures as required.
• Possesses a detailed understanding of the theoretical principles for major manufacturing processes as applied by the equipment used in the manufacturing process.
• Designs issues and evaluates trials to develop robust manufacturing processes and to reprocess or rework batch failures.
• Responsible and accountable for troubleshooting and resolving challenges during the manufacture of pharmaceutical liquid dosage forms at all Apotex sites.
• Anticipates problems and interruptions and develops contingency plans to accurately scope out length of task / project.
• Uses advanced techniques to identify root causes of issues with proposed formulations and processes and plan a course of action for further investigation and corrective action as required.
• Uses advanced problem-solving techniques to assess equipment and processes for optimal use and to arrive at best practices for projects under development.
• Responsible and accountable for decisions made to eliminate problems in Production and to rework or reprocess batch failures.
• Accountable for all changes in deadlines project deliverables and other areas when making decisions.
• Reviews scientific literature attends appropriate training seminars & presentations to maintain expertise in formulation development manufacturing equipment and processes raw materials pharmaceutical technologies and related areas.
• Provides professional expertise and performs consultations on issues regarding Process Support to other members of Technical Support Services department and other departments.
• Recruits trains develops and manages effectively the ongoing performance of their direct reports which includes but is not limited to :

Reviewing and updating development plans for all direct reports ensuring that all direct reports are properly trained and qualified according to our Global Training and Employee Qualification Enterprise Policy.

Job Requirements

University degree in Chemistry Pharmacy Pharmaceutical Technology Chemical Engineering or related science

Extensive knowledge and experience in pharmaceutical processes & equipment

Minimum of 10 years of successful working experience in the pharmaceutical industry with related experience in formulations development of liquid dosage forms scale up and / or technology transfer.

At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.

We offer 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.

Key Skills

Invasive Cardiology,Logistics Distribution,Corporate Risk Management,Field Marketing,IT Sales,Administration Support

Employment Type : Full Time

Experience : years

Vacancy : 1