Duties:

• Lead and manage facility and engineering systems which are in full compliance to Patheon and regulatory standards, and to a level which receives recognition from clients and auditors.
• Lead a highly motivated workforce which strives to achieve the goals and objectives of Patheon while working together with all clients and other internal customers.
• Provide a high level of Health, Safety and Environment compliance which not only achieves acceptance from regulatory authorities and the community, but also enhances the work environment of all employees.   
• Provide an environment for all department associates to strive to advance to both personal and professional development.
• Provide project management to facility, production equipment and warehousing capital expenditures.
• Ensure maintenance of the facility, manufacturing and warehousing equipment within the regulatory requirements as well as ensuring maximum effectiveness of the equipment.

Qualifications:

• Mechanical, Chemical, Electrical Engineering Degree. Other degrees may be considered with equivalent experience. 
• Minimum 10 years experience in a similar role in a pharmaceutical or related industry.
• Professional Engineering designation.
• Proven leadership in a large multi disciplined maintenance organization with excellent interpersonal, oral and written communication skills.
• Knowledge of Ontario, Health and Safety legislation, GMPs and project management.

Duties:

• Repair equipment and facilities on an emergency basis.  Be able to trouble shoot electrical, mechanical, hydraulic and plumbing issues
• Perform engineering modification and project-type work, maintenance, operate hand tools and plant service equipment
• Maintain logs as required.  Pick up parts from suppliers.  Complete work orders and PM sheets, as well as weekly allocation sheets.  Attend meetings and training seminars.  Update PLC programs.  Make modifications to equipment
• Maintain updated records of changes on documents such as manuals, schematics, drawings etc
• Perform electrical work to ESA standards
• Capable of performing minor calibrations

Qualifications:

• Ontario Electrical License
• Minimum 5 years hands-on experience
• Previous work experience in a controlled and regulated environment
• Good knowledge of GMP guidelines
• Ability to work from diagrams, schematics and specs.
• In this role it is essential to perform shift work
• Demonstrated commitment to our fundamental principles of Integrity, Respect and Excellence
• Proficiency with the English language

Duties:

• Participate in or lead the design/evaluation of formulations and manufacturing processes for solid, semi-solid or liquid dosage forms.
• Write development reports.
• Participate in or lead problem solving for formulations, equipment and processes.
• Write protocols and manufacturing cards for feasibility and clinical trial materials.
• Write and ensure timely execution of protocols and provision of results in accordance with current Good Manufacturing Practices and company standards.
• Present interpreted results and updates to Business Development, Client Services, Pharmaceutical Development Services (PDS), Operations and individual clients.
• Other duties as required.

Qualifications:

• Minimum M.Sc. (Ph.D. preferred) in Pharmaceutics (other fields with commensurate experience in early development and/or pediatric development)
• Minimum 3 years of experience
• Knowledge and familiarity with early formulation development and processes, cGMP and FDA compliance knowledge.
• Demonstrable understanding of formulations and processes (from laboratory to production scale) and familiarity with the drug development process.
• Demonstrable Good Manufacturing Practices (GMP’s) and United States Food and Drug Administration (FDA) compliance knowledge.
• Computer proficient.
• Solid, semi-solid and liquid product experience.
• Strong organizational skills.
• Able to work well independently and in a team environment.
• Established interpersonal and communication skills.
• Communicates and co-operates with others to meet project and team objectives.
• In this role, it is essential to perform shift work.
• Demonstrated commitment to our fundamental principles of Integrity, Respect & Excellence.
• Proficiency with the English language.
• Actively acquires new skills/knowledge relevant to the drug development process.
• Draws on experience and demonstrates innovative approach.
• Interested in developing leadership skills.
• Established quality, regulatory and production mindset including an appreciation for client service and the contract manufacturing industry.

Duties:

• To supervise a Group of Analysts who are responsible for the development of analytical procedures in support of client pharmaceutical product development projects.
• To provide technical leadership for analytical challenges during product development
• To ensure that the validation studies, analyses of experimental samples, GMP batches and stability samples are conducted by the Group strictly in accordance with cGMP and Patheon SOPs, protocols and CTMLPs
• To ensure that all AD laboratory documentation within the group are completed to the highest quality standards and that any formal investigations e.g. Out of Specifications or QIR/QDR are conducted promptly and thoroughly
• To convey results of analytical studies and participate in project discussions with colleagues within other Departments within PDS and during teleconferences with clients
• To supervise the schedules for each analyst in the Group to ensure that studies are completed in accordance with project timelines and client expectations
• To supervise the training of all analysts within Group to ensure that they are fully competent to conduct the studies assigned to them and that they are provided with a career development plan
• To make recommendations to Manager for additional personnel and equipment resources that might be needed to meet our project commitments
• To keep up to date with advances in analytical, pharmaceutical and regulatory developments and to make recommendations to Manager for any new types of Analytical technology that should be considered within AD
• Other duties as assigned

Qualifications:

• Ph.D or M.Sc in a science related to pharmaceutical Analysis and at least 3 years of pharmaceutical analytical development experience or, B.Sc.in a science related to Pharmaceutical Analysis and at least 5 years of pharmaceutical analytical development experience.
• Supervision and/or leadership and training experience
• Previous method and analytical instrumentation validation experience in the pharmaceutical industry.
• Exceptional cGMP, GLP, and FDA compliance knowledge.
• Superior interpersonal and communication skills (both oral and written), leadership ability and organizational skills.
• Works well independently and in a team environment
• Proficiency with the English language
• Proficient with MS Word applications.

Duties:

• To successfully lead the management of project-related activities of multiple teams/groups in Pharmaceutics & Process Technology (PPT) and Analytical Development (AD).
• As a member of the management team, support the management of the PPT and AD departments and the PDS business.
• Lead the development of infrastructures in PPT and AD to:
• Ensure that the facility and personnel comply with GMP and EH&S requirements
• Ensure efficient execution of projects
• Ensure that all documentation is generated efficiently and in accordance with the required quality standards.
• Encourage strategic, scientific, technical discussions through correlating activities between PPT and AD that would accelerate development process
• Provide leadership in establishing and developing scientific and technical initiatives relevant to the PDS business.
• Provide leadership for regulatory reports and client/regulatory audits as appropriate for PDS.
• Develop and maintain infrastructure for setting and monitoring performance objectives and career development plans for PPT and AD staff.
• Periodically review PPT and AD organizational chart; if necessary recommend changes to meet departmental objectives and career development needs. 
• Lead scientific/technical discussions during meetings with prospect clients; match PPT/AD capabilities and expertise with prospect client needs where possible; ensure prospect clients are aware of PPT/AD capabilities and expertise where relevant.
• Maintain working relationships and scientific/technical dialogue between PPT/AD and established clients.
• Maintain collaborative, working relationships with departments outside PDS, both internally and cross-site

Qualifications:

• Ph.D. in pharmaceutical science or technology or related discipline.
• Minimum 10 years experience in developing formulations and manufacturing processes for pharmaceutical products from early phase to validation.
• Experience in developing and/or implementing quality systems in an R&D environment.
• Experience in organizational development.
• Demonstrable ability to help others develop skills required in an R&D environment.
• Demonstrable experience in establishing relationships with prospect and new clients.
• Results oriented with ability to manage multiple demands under challenging timelines.
• Proficiency with the English language 
• Possesses a highly developed quality, regulatory and production mindset including an appreciation for client service and the contract manufacturing industry.