Director, Biologics Manufacturing
TERMS OF EMPLOYMENT
This is a full-time, permanent position (1.0 FTE; min. 40 hours/week)
Qu Biologics is a private, clinical-stage biopharmaceutical company located in Vancouver, BC, that develops Site Specific Immunomodulators (SSIs) which are designed to restore the body’s normal immune function to reverse the chronic inflammation underlying many conditions including cancer and inflammatory bowel diseases (IBD).
IS QU FOR YOU?
Love doing something that you can feel passionate about? Excited by innovation? Love new ideas and working with a creative, fun and inspired team? Want to make a difference in the world and work with people who feel the same? Then this is for you!
• You are innovative and also practical and enjoy finding the most efficient and cost-effective solutions to real-world problems
• You understand the importance of identifying and overcoming rate-limiting steps to ensure that projects are moving forward as quickly as possible, without sacrificing quality
• You value respectful, open communication and inspired teamwork to achieve shared goals
• You are well-organized, understand the importance of detail, and are able to multi-task and prioritize duties effectively
• You always ask “Why?”
Take a look at our core values and meet the Qu team in this video where Qu’s Research Operations Manager, Momir Bosiljcic, takes you on a tour of Qu Biologics!
This job posting is for a full-time (1.0 FTE) position. The successful candidate must be a results-oriented “do-er” who is happy to roll up their sleeves and do whatever it takes to get the job done. Excellent organizational and project management skills, alongside the ability to interact positively with other team members are absolutely required. This position requires a proven ability to seamlessly manage outsourced activities with North American and European vendors on multiple time zones, to ensure that Qu’s manufacturing projects are conducted as quickly and as cost-effectively as possible. You will report to the VP, Operations.
Specific duties and responsibilities will include:
• Oversight and project management of all aspects of GMP biologics manufacturing. This also includes significant involvement and support for quality control and quality assurance aspects of product characterization for Qu’s Site Specific Immunomodulators (SSIs), used in Phase 1-3 clinical trials in Canada, the US and Europe
• Strategic input with regards to the overall product development plan for Qu’s lead candidate SSI
• Ensure availability of Standard Operating Procedures, Qualification and Validation protocols and reports sufficient to ensure robust, reproducible product manufacture and testing, meeting or exceeding regulatory requirements and expectations.
• Direct completion of documentation to support CMC components of regulatory submissions for Health Canada, the FDA and the EMA and interact with regulatory authorities, as needed, to support CMC submissions
• Oversight of in-house product development activities including: production of SSIs for preclinical research purposes; further development of critical assays to define drug product and ensure characterization of Qu’s drug products and optimization of drug product formulations
• CMC support to Qu’s business development team for discussions and due diligence with potential pharma and biotech partners, as needed
• Strategic input with regards to ‘next generation’ product development, as required.
• Graduate degree (MSc or PhD) in biochemistry or chemical, biochemical or bioprocess engineering
• A minimum of ten (10) years of experience in an industrial-scale microbial fermentation & purification facility with commercial manufacturing capabilities (or an equivalent role in a pharmaceutical or biotechnology company), with at least five (5) years in a project management and/or leadership role
• Demonstrated competency in development of Quality Assurance strategies and structures which provide both:
>> the flexibility necessary for clinical progression of biologics
>> and the requirement to meet or exceed future regulatory requirements for commercial products
• Experience in all stages of product development for a biologic and/or vaccine, from product prototype, Phase 1-3, through to a market application
• Experience with regulatory guidelines and submissions (e.g., INDs, NDA/BLAs) for biologics and/or vaccines in the US (FDA) and Europe (EMA); experience with guidelines and submissions (e.g., CTA) in Canada (Health Canada) an asset
• Working knowledge of bacterial fermentation processes, preferably including experience with BioSafety Level 2 (BSL-2) organisms; experience with whole-cell killed bacterial vaccines is strongly preferred
• Experience developing analytical methods and purification processes for bacterial components including HPLC/IC and small-scale preparative chromatography, mass spectrometry and bacterial fractionation (including vesicle generation and purification) is a welcome asset
• Ability to thrive in a collaborative environment, taking into account multiple opinions from both in-house team members and external advisors, while maintaining departmental direction and focus
• Strong delegation and people management skills with a genuine interest in training and growing in-house CMC personnel
• Flexibility to travel within North America and to Europe for site visits to CMO and other vendors, as deemed appropriate, to ensure success and efficiency of manufacturing activities
DESIRED START DATE
June 1st 2017
Salary will be negotiable, depending upon professional profile, qualifications, experience, performance and leadership. Anticipated range; $100,000 – $140,000 per annum, corresponding to $48.08-$67.31/hr. Complete compensation package will include stock options, three (3) weeks annual vacation, a health and wellness spending account and free onsite parking.
Qu Biologics Inc.
CRA Business Number 842333817
BUSINESS ADDRESS & LOCATION OF WORK
Suite 138 – 887 Great Northern Way
Vancouver, British Columbia
Canada V5T 4T5
Note: this position requires an on-site presence, and is not suitable to working remotely
HOW TO APPLY
Please e-mail a cover letter and a copy of your curriculum vitae in pdf format to the attention of Gillian Vandermeirsch, VP, Operations at: firstname.lastname@example.org. Applications may also be sent by regular mail to the business address provided above. Applications will not be accepted by fax or over the phone.
We thank all applicants for their interest in this position. We regret that only those selected for an interview will be contacted. Please note that we will not be fielding inquires by phone.