PRINCIPAL DUTIES:

• Water sampling and testing to USP, EP, BP, JP or other pharmacopoeia standards.
• Media preparation/glassware cleaning.
• Temperature Chart changes and daily incubator readings.
• Environmental monitoring at all Patheon facilities.
• USP Limit test, including preparatory testing of all raw materials and finished product.
• USP Preservation Effectiveness Testing (PET’s)
• Train technicians in new techniques and oversee the progress as required.
• Documentation control, i.e. proper laboratory notation for data entry to log books and report writing.
• Other related duties as assigned

SKILLS/EXPERIENCE REQUIRED:

• Minimum B.Sc. degree in Microbiology.
• Minimum 3 years demonstrated microbiology laboratory experience in the pharmaceutical field.
• Proficiency with the English language.
• Must be able to work independently and possess excellent organizational skills.
• Must have excellent verbal and written communication skills.
• Computer proficiency.

Principal Duties:

• Manage 10-15 active medium clinical packaging projects with minimal assistance from Senior Manager/Associate Director, Clinical Project Management. 
• Manage projects with 5000 or greater accrued project hours per quarter
• Coordinate the dispensing, packaging, labelling, dispatch and quality of clinical trials supplies
• Develop and implement packaging/labelling strategies
• Ensure packaging/labelling documentation are of high quality, generated in a timely fashion, and comply with GMP
• Design, create and generate clinical labels utilizing a computerized clinical trial labelling system
• Resolves project issues and resource constraints within the team and with moderate assistance.
• Facilitate positive team member interactions and manage conflict with minimal assistance.
• Establish/practice standard project reporting procedures to client and management (i.e. minutes, agendas).
• Make presentations and contribute to team and department meetings and occasionally to rest of PDS Canada.
• Author, revise and train on Standard Operating Procedures (SOPs) relating to job responsibilities

Client Management:

• Manage client satisfaction by managing client expectations efficiently with minimal assistance from Senior Manager/ Associate Director, Clinical Project Management.  Maintain very good relationship with client and grow it positively.

Product Development:

• Make recommendations on clinical packaging and regulatory guidelines to client.
• Keep abreast of current trends and literature, share with team.

Business Management:

• Plan, monitor and ensure completion of all activities outlined in the client quote for each project.  Prepare amendments for changes of scope in a timely manner.
• Create and maintain client timelines within MS Project.
• Contribute to Unit monthly forecasts by managing project EMVs.

 SKILLS/EXPERIENCE REQUIRED:

• Minimum B.Sc., ideally B. Pharmacy with 5 years industry experience preferably in pharmaceutical industry
• Alternately, a Pharmacy Assistant Diploma with 5-10 years experience in clinical packaging
• One of the following:
  • MBA, M.Sc.,  Ph. D. or PMP certification
  • 5 years product development experience
  • 5 years PM experience
  • 5 years client management experience
  • 2 years experience in managing department in pharmaceutical industry.
• Well organized and detail oriented
• Ability to prioritize multiple project deliverables
• Strong interpersonal and communication skills, as well as the ability to motivate and influence.  Client interface experience and strong negotiating skills are an asset.
• Ability to meet deadlines and prioritize
• Strong attention to detail.
• Excellent written and oral communication skills
• Ability to work both in a team environment as well as independently as required
• Strong team skills
• Good knowledge of GMP requirements in adherence to TPP, FDA and MAA standards.
• Strong problem solving and evaluation skills.
• Experience in leading clinical packaging teams.
• Candidates with an M.Sc., MBA, or PhD with less industry experience will be considered

PRINCIPAL DUTIES:         

·         Documentation Review (manufacturing, packaging, in-process analytical, component). 

·         Master documentation preparation & management. 

·         Co-ordination of finished product/raw material release.

·         Co-ordination of QA activities in Clinical Packaging project. 

·         Co-ordination of validation projects. 

·         Maintain SOP, DR, Complaint, Audit Management, programs (prepare for approval, maintain annual review, updates, and training schedule/records).

·         Manage training program. Complete and document New Employee Orientation/GMP/SOP training.

·         Prepare, co-ordinate and execute IQ/OQ, Validation as required.

·         Complete in-process analytical testing, bulk and packaging material sampling and inspection

·         Responsible for safety and to protect themselves and fellow employees from harm.

SKILLS/EXPERIENCE REQUIRED:

·         University Degree in a recognized science, or alternatively sufficient industry experience (5-7 years) in QA.

·         Previous experience quality assurance, compliance, validation experience.

·         Strong computer skills including, Microsoft Word, and Excel a must.

·         Effective verbal and written communication skills

·         Extensive understanding of GMPs and SOPs, and their application.

·         Well organized and detail oriented with the ability to prioritize multiple tasks.

·         Good math and communication (verbal and written) skills.

·         Strong interpersonal skills

·         Previous MRP experience. (e.g. CINCOM) and previous experience in electronic data management systems (e.g. Trackwise)

Principal Duties:

• Lead management of the global clinical packaging project management and clinical packaging and label design functions. Includes oversight of day-to-day work and communication to stakeholders.
• Manage revenue stream
• Lead the development of the infrastructures for the above business, including but not limited to Quotations and Project Management to:
  - ensure efficient execution of projects.
  - ensure that all documentation is generated efficiently and in accordance with the required quality standards.
• Oversee implementation of clinical labeling system and establish processes for packaging and label design activities
• Develop and maintain infrastructure for setting and monitoring performance objectives and career development plans for PM staff. Be a resource for direct reports and train and coach as required; lead, guide and motivate all members of the unit
• Periodically review unit organizational chart; if necessary recommend changes to meet departmental objectives and career development needs. 
• Lead scientific/technical discussions during meetings with prospect clients; match team and staff capabilities with prospect client needs where possible; ensure prospect clients are aware of capabilities where relevant.
• Maintain working relationships and scientific/technical dialogue (including collaborations and negotiation) between PDS PM, Clinical Packaging Project Management and established clients.
• Keep abreast of new global clinical packaging regulations and their impact on current practices. Recommend and implement changes where necessary. Represent Patheon on the Canadian Clinical Supplies Association within Canada and other such associations, as necessary.

SKILLS/EXPERIENCE REQUIRED:

• Minimum 10 years pharmaceutical industry experience
• 5-7 years clinical supplies project management and packaging experience
• Minimum B.Sc.; MBA, M.Sc. or PhD an asset
• 3 years of project management experience
• Well organized, and detail oriented
• Strong leadership and conflict resolution skills
• Ability to prioritize multiple tasks across a portfolio of projects
• Excellent interpersonal and communication skills (both oral and written), computer skills, leadership, motivation and organizational qualities.
• Strong presentation skills
• Proven people management experience (5-7 years managing direct reports) within a pharmaceutical R&D environment.
• Proven client interface experience and strong negotiating skills – a “solution oriented” mindset
• Experience in organizational development
• Strategic thinker and planner.
• Has a mindset for practical systems that add value.
• Helps others to understand their potential and areas for improvement.
• Exemplary team building and motivational skills.
• Uses established scientific/technical acumen, strong interpersonal skills and thorough knowledge of clinical supplies packaging business to favorably influence discussions with prospect/new clients.