Process Biochemist (Process Sciences)
Vancouver, British Columbia, Canada
QLT Inc. is a global pharmaceutical company specializing in the discovery, development and commercialization of innovative therapies. Combining expertise in ophthalmology, oncology and photodynamic therapy, QLT has commercialized two products to date, including Visudyne therapy, which is the most successful ophthalmology product ever launched.
We are in the final construction phase of a new state-of-the-art Pilot Manufacturing facility in Vancouver which encompasses isolator-based manufacturing and a fully-integrated SCADA system.
You will be responsible for designing and executing laboratory studies, process development experimentation and characterization. You will also develop processes for the manufacture of clinical and commercial production of drug products as well as compile, analyze, prepare and summarize information in reports for in-house review. Integrating various information into a uniform style for regulatory compliance as well as assisting with documentation development for instructional, reference and/or informational purposes will also be part of the mix.
Specifically, you will:
- design, execute and oversee laboratory work according to applicable study protocols, work procedures, SOPs and GLPs;
- lead the creation of development approaches and coordinate the execution of development studies internally and at third party contract manufacturing sites or other contract agencies in support of product development, clinical and commercial batches;
- outline development studies within study protocols and accurately complete final development reports;
- analyze/evaluate development data gained from departmental experiments to form robust and rugged manufacturing processes;
- work with junior staff to accomplish development and validation projects;
- determine needs and solutions to support products at product development, clinical and commercial stages;
- liaise with external consultants, technical sales representatives or other contacts to obtain specific technical information;
- ensure that all regulated activities are conducted in compliance with any pertinent GMP requirements and in accordance with the scientific standards, ethical and professional values, management philosophy, established priorities, policies and practices;
- observe all laboratory safety regulations and guidelines and review any safety concerns with supervisors.
You bring to this role:
- a BSc and 8 - 10 years’ experience or an MSc and 5 - 7 years’ experience;
- coursework and laboratory expertise in Microbiology, Biochemistry, Chemistry or Biochemical Engineering;
- detailed knowledge of sterile and topical dosage form as well as process design/troubleshooting;
- experience developing pharmaceutical processes and parameters for commercialization;
- demonstrable knowledge of experimental design, analysis and technical reporting;
- the ability to critically assess technical situations and recommend paths to resolution;
- excellent team building and communication skills;
- working knowledge of GMP regulations;
- computer proficiency with Word, Excel, statistical software for trending and, ideally, Lotus Notes.
QLT Inc. offers a flexible and comprehensive compensation package geared toward individual lifestyles. For opportunities with QLT Inc. and to apply online, visit www.qltinc.com.
Reference Job Code: QLT32803
Attn: Human Resources
887 Great Northern Way
QLT Inc. is an Equal Opportunity Employer