Duties:

• Conduct maintenance and calibrations for each new and existing piece of analytical
• equipment in accordance with a schedule.
• Maintain detailed and accurate records to meet all regulatory and user requirements.
• Troubleshoot and repair malfunctioning apparatus.
• Comply with all current SOPs and procedures.
• Limited travel to other sites as needed
• Ability to respond to emergency after-hours pager (on a rotating basis)

Qualifications:

• B.Sc. in a science related to Pharmaceutical Analysis or Analytical Instrumentation.
• Some knowledge of GMP
• Good communication skills (both oral and written), and organizational skills.
• Strong computer proficiency with MS office programs.
• Ability to meet deadlines and prioritize
• Proficiency with the English language

Duties:

• Assist in determining experimental plan (equipment train, batch sizes) for PDS process development projects at the Whitby site.
• Oversee Technology Transfer Plans.
• Participate in Client meetings to discuss strategies for process development/transfer of new products to Whitby and provide technical expertise.
• Work with Process Development Management, Project Managers, Process Pharmacy and Production to ensure successful execution of process development projects and transfer of products to Whitby site meeting client deadlines and goals.
• Design experiments to allow scale up and manufacture of feasibility, clinical, registration and commercial batches.
• Maintain expert knowledge of pharmaceutical processes, equipment, instrumentation and procedures.
• Write/review instrumentation of production/processing documentation and relevant SOPs.
• Conduct trouble shooting of identified products and partner with Clients to optimize the manufacturing processes of said products.
• Prepare process development protocols for PDS projects.
• Provide expert data interpretation and prepare reports for PDS projects.
• Provide technical training and leadership for other staff as required.
• Develop and implement (with Environmental Health & Safety) systems and technologies to assure safety, quality and productivity.
• Comply with applicable cGMPs and maintain knowledge of industry trends in pharmaceutics and cGMPs.

Qualifications:

• B.Sc., M.Sc. or Ph.D. in chemistry or pharmaceutical sciences or a related engineering discipline.
• Minimum 3 years of previous drug development experience, including scale-up and technology transfer of solid, controlled release, semi-solid and liquid dosage forms. Process Analytical Technology and Design of Experiments knowledge would be an asset.
• Knowledge of FDA, HPFBI, cGMP; current standard, policies and trends.
• Extensive experience and knowledge of regulatory requirements for NDA and SNDA submissions and pharmaceutical industry.
• Experience with MS Office.
• Excellent interpersonal, oral and written communications skills.  

Duties:

• To perform testing and assays in accordance to approved methods and SOPs:
• All duties must be performed in strict compliance to all Patheon quality systems (SOPs, cGMP)
• To document all experimental data in accordance with cGMP and Patheon SOPs
• To recognize and report OOS results or deviations to Supervisor immediately
• To assist in method validation as directed by AD Supervisor
• To assist in trouble shooting and investigations as required by AD Supervisor
• To comply with all EHS requirements and participate in EHS training
• Other related duties as assigned

Qualifications:

• Minimum B.Sc. in Chemistry, or related science, with at least 2 years experience in pharmaceutical analytical development
• The candidates must demonstrate a good understanding of basic chemistry, chromatography (eg HPLC, GC, TLC) and spectroscopic technologies (eg UV, IR)
• Candidates should demonstrate good problem solving skills and logical approach to solving a scientific problem
• Interest in improving their skills and knowledge in pharmaceutical development
• Excellent written and oral communication skills
• Proficiency with the English language