Qu Biologics Hiring for Director/Vice President Manufacturing at Burnaby, BC Full Time

TITLE

Director/VP Manufacturing

TERMS OF EMPLOYMENT

This is a full-time position (1.0 FTE)

COMPANY PROFILE

Qu Biologics is a private, Phase 2 clinical-stage biopharmaceutical company located in Burnaby, BC developing Site Specific Immunomodulators (SSIs), a novel immunotherapy platform designed to restore normal immune function to reverse the immune dysregulation underlying many conditions including cancer and chronic inflammatory diseases.

IS QU FOR YOU?

Do you love doing something that you can feel passionate about? Are you excited by innovation, new ideas, and working with a creative, fun, and inspired team? Then, this is for you! We’d love to hear from you if:

• You are well-organized, understand the importance of detail, and can multi-task and prioritize duties effectively
• 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 are innovative, practical, and enjoy finding the most efficient and cost-effective solutions to real- world problems
• You value respectful, open communication and inspired teamwork to achieve shared goals
• You always ask “Why?”

POSITION DESCRIPTION

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 time management skills and the ability to interact positively with other team members are absolutely required.

The position requires a proven ability to multi-task efficiently in the area of biologics manufacture, to ensure that Qu’s SSI Technology Platform is fully supported and led in all CMC activities, including GLP toxicology materials through to Phase 1, Phase 2 and Phase 3 clinical trial material, as well as outsourced contract manufacturing of aseptically manufactured drug substances in all stages of development and scale-up.

The successful candidate will provide proven leadership and support with cross-functional duties across the organization including preclinical and translational research, Finance, and Operations; this includes extensive interactions with outsourced fermentation, formulation, and analytical teams, preclinical and clinical translational teams as well as project leadership responsible for the development of Qu Biologics SSI’s. The Director/VP Manufacturing will report directly to the CEO.

The successful candidate will play an essential role in creating documentation and maintaining compliance consistent with GLP and cGMP standards for pre-clinical, early and late-stage clinical development, including pre-IND/CTA meetings from early stage through Phase 3 clinical development and support regulatory submissions.

The successful candidate will also play an essential role in communicating CMC progress and strategy to Qu Biologics’ Board of Directors, shareholders, and potential investors and Pharma partners.

Specific duties and responsibilities include:

• Establish and lead the implementation of Qu Biologics’ CMC strategy for all of Qu Biologics’ SSIs in all development stages ranging from preclinical GLP studies through to Phase 3 clinical trials.
• Directly manage and oversee all activities of the CMC department and team.
• Lead and oversee the development, transfer and qualification of cGMP compliant processes and methods for sterile and aseptic produced drug products.
• Oversee Qu’s internal fermentation manufacturing activities.
• Lead outsourcing of manufacturing and development activities, contract drafting, review and negotiation.
• Lead and oversee the management and distribution of regulated drug product supplies to internal and external partners.
• Lead and oversee SOPs, Protocols/Reports, BPRs and Specifications for Pharmaceutical Development and Manufacturing activities.
• Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of CPPs and CQAs, development of drug product specifications and shelf-life estimates for drug product formulations.
• Review CMC project plans and timelines to ensure all projects are appropriately prioritized and key goals are met on time.
• Develop and maintain an in-depth knowledge of drug product manufacturing and development technology and the associated regulatory requirements.
• Author and review CMC regulatory submissions.
• Communicate project status and concerns to the CEO and Board of Directors
• Effectively work within the Process Development department and with cross-functional team leaders to achieve corporate and program goals.
• Ensure overall operational budget is within the approved budget and timeline.
• Communicate CMC progress and strategy to Qu Biologics shareholders and potential investors and Pharma partners.

REQUIRED QUALIFICATIONS

• Advanced degree in a relevant pharmaceutical science, or related field.
• Minimum of 10-15+ years of industry experience with increasing responsibilities in biopharmaceutical manufacturing/fermentation and drug product development.
• Extensive experience with development and optimization of manufacturing processes, and oversight of distribution campaigns for supplies ranging from GLP toxicology supplies to cGMP Phase 3 clinical trial materials.
• Successful management track record with oversight of entry level to executive director personnel.
• Previous experience with both aseptically produced drug substances and drug products is a plus.
• Excellent interpersonal verbal, written, and presentation skills in communication with internal and external stakeholders.

LANGUAGE REQUIREMENTS

Fluent English

DESIRED START DATE

ASAP. The position is open so please apply!

COMPENSATION

Salary and vacation commensurate with experience.

COMPANY & LOCATION OF WORK

Qu Biologics Inc.
4475 Wayburne Drive, Suite 305
Burnaby, British Columbia
V5G 4X4 Canada

While we thank all applicants for their interest, only short-listed candidates will be contacted. Please note that we will not be fielding inquires by phone.

Job Type: Full-time

Additional pay:

• Bonus pay

Benefits:

• Casual dress
• Commuter benefits
• Dental care
• Disability insurance
• Extended health care
• Life insurance
• On-site gym
• On-site parking
• Paid time off
• Stock options
• Vision care

Schedule:

• Monday to Friday

Application question(s):

• Do you have extensive fermentation drug development experience?
• Have you led drug development manufacturing through Phase 1, Phase 2, and Phase 3?

Experience:

• drug product development: 10 years (required)
• biopharmaceutical manufacturing/fermentation: 10 years (required)