Employment 

Associate Director, Pharmaceutical Development - Ref # PS-1119

August 13, 2010

QLT Inc.

1. Evaluates manufacturing processes and equipment in order to develop lab, pilot and commercial-scale manufacturing processes and equipment. This includes activities such as evaluation of equipment for scalability and performance as well as examining multiple vendors for equipment and scalability of processes.
2. Plans project execution strategies and evaluates process technologies for applicability to clinical and developmental needs.
3. Assesses current and future staffing needs based on organizational goals and budget realities. Recruits, trains, and retains team members. Establishes performance criteria, monitors results and recommends corrective action where appropriate. Coaches and develops knowledge and competencies of team members.
4. Manages ongoing operations of the Pilot Manufacturing Facility to ensure compliant and economic operation.
5. Coordinates personnel and establishes schedules to conduct experiments and produce development and clinical batch materials.
6. Directs external groups and individuals, including third party development and manufacturing facilities, to access expertise not available within the Company. Ensures that projects undertaken at third party facilities are completed in a fiscally responsible manner and in accordance with internal standards and established timelines. Participates in vendor selection, contract negotiations, and technical issues resolution.
7. Develops and maintains budgets for projects and manufacturing campaigns.
8. Manages process development projects in support of clinical development programs and commercial supply chain initiatives.
9. Directs the preparation of and reviews reports including proposals for studies, protocols, standard operating procedures and manufacturing documents.
10. Contributes to strategic planning for the Pharmaceutical Development Department.
11. Reads pertinent literature to maintain awareness and understanding of developments related to current or anticipated research activities.
12. Ensures that the responsibilities of the position are carried out in accordance with the Company's policies, operating and performance standards, ethical and professional values, and current Good Manufacturing/Laboratory Practice regulations. Follows all appropriate safety regulations required for both internal and external activities. Ensures that laboratory facilities and equipment are maintained in a clean, safe and productive manner.
13. Collaborates and interacts with others in a mutually supportive and co-operative manner that reinforces the concept that staff at all levels are expected to seek ways in which they can support and assist others to achieve expected results, as well as to be effective in their own accountability areas.

1. A B.Sc. and a minimum of 8 years of related experience in a similar work environment. Experience must include API and Drug Product development and at least 2 years in a management role.
2. Detailed working knowledge of pharmaceutical process development/design and pharmaceutical manufacturing. Experience in development of various dosage forms (oral, topical ophthalmic, parenteral) and sustained release drug delivery systems highly preferred.
3. Ability to analyze manufacturing operations and take effective action for successful completion of production.
4. Ability to analyze and evaluate technologies for creative and cost-effective process solutions.
5. High level of competency in generating validatable processes and procedures.
6. Demonstrated ability to deliver high quality results under tight timelines.
7. Highly effective English communication skills including listening, written, oral and presentation.
8. A demonstrated ability to be resourceful in accessing expertise outside QLT.
9. Flexible and adaptable.
10. Proven leadership skills including the ability to train, coach and develop employees, and to assess resource allocation for project execution.
11. Demonstrated ability to work effectively in a team environment by treating others with respect, valuing differences, contributing ideas, willingly assisting others in the pursuit of team objectives, following through on commitments, and collaborating across functional lines in order to achieve corporate goals.
12. Comprehensive knowledge of cGMP requirements (APIs through to parenterals).