Director, Process Development

at  Aspect Biosystems

We are seeking a Director, Process Development to lead the strategy and execution of process development activities for our pipeline of Bioprinted Tissue Therapeutics. Reporting to the Chief Technical Operating Officer, this role requires a deep understanding of biopharmaceutical process development and regulatory requirements associated with cell-based therapies and combination products. This role will oversee the process development of therapeutic cells, biomaterials, and Bioprinted Tissue Therapeutic (BTT) products and is ultimately accountable for the successful manufacturing of drug substances and drug products for multiple Bioprinted Tissue Therapeutics.

WHO WE ARE

Aspect Biosystems is a Canadian biotechnology company creating bioprinted tissue therapeutics to transform how we treat disease. Our bold team of innovators and entrepreneurs have joined us from all over the globe to create a new class of regenerative medicine and work towards a future where our bioprinted tissues are used to save lives and make people healthier. We are endlessly curious and wildly passionate about what we do. Every person on our team is a key contributor to our success and is eager to roll up their sleeves to make a difference in the ever-changing world of biotech. If you are committed to making a real impact and accelerating the development of life-changing therapies, we want to hear from you!
Curious about our current perks and benefits? Learn more here.
At Aspect Biosystems, our strength has always been in our diversity. Different people, thinking differently, unified in creating a world that is better for us all. We are committed to creating an inclusive environment for everyone on our team. All aspects of employment — including the decision to hire, promote, discipline, or terminate — are based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, colour, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, provincial, or local law.
If you’re interested in joining our team but don’t see a job posting that matches your experience or background, we encourage you to submit a general application to be considered for future opportunities

Qualifications

• Education + Experience: PhD with 10+ years or MSc/BSc with 15+ years directly related experience in process development within the field of cell therapy.
• GMP & Regulatory Knowledge: You are knowledgeable about GMP requirements for biologic or cell manufacturing and have experience writing or contributing to regulatory filings.
• Beneficial Experience: You have experience with scaling cell therapy processes, operations, and activities. Preferably, you also have experience working with pluripotent cells and biomaterials/bioinks.
• Drug Development Knowledge: Advanced knowledge of the drug development process and the interdependencies of individual development activities and projects.
• Computer Skills: Proficiency with MS Office, utilization of PM software (Smartsheet or other Gantting software

• Provide strategic, efficient, high-quality leadership and technical expertise in the process development of cell-based combination products, ensuring alignment with our company’s vision and regulatory requirements.
• Directly manage the Process Development team and be accountable for ongoing high-quality delivery or work and effectiveness of the teams.
• Forecast, schedule, and track all process development activities to ensure timely disposition and accountability for Key Performance Indicators, ensuring alignment with Company objectives directly and through the management of others.
• Provide input to the overall Technical Operations strategies and operational planning.
• Lead a team of cross-functional stakeholders to drive strategic decisions into process development execution.
• Spearhead the design and execution of process development strategies for stem cell culture, differentiation, and integration with biomaterials using our bioprinting manufacturing technology.
• Facilitate alignment with senior leadership and appropriate prioritization within process development priorities.
• Liaise with various internal and external stakeholders to generate and execute preclinical and clinical project plans.
• Author, review, and approve process development, transfer, validation study protocols and reports to ensure high quality documentation to support regulatory filings.
• Enable and communicate the team’s mission, strategic direction, business goals, objectives, and priorities.
• Foster a culture of flexibility, nimbleness, efficiency, and a strong compliance mindset while promoting positive collaboration among all team members, partners, and key stakeholders.
• Ensure processes are transferred and products are delivered in a safe, timely, and financially responsible manner in compliance with FDA, Health Canada, and EMA regulatory requirements.
• Analyze operating costs and drive towards efficiency improvement.
• Successfully attract, develop, and retain key talent.
• Develop and maintain departmental budget.
• Present to senior leadership and cross-functional teams across Aspect.

Qualifications

• Education + Experience: PhD with 10+ years or MSc/BSc with 15+ years directly related experience in process development within the field of cell therapy.
• GMP & Regulatory Knowledge: You are knowledgeable about GMP requirements for biologic or cell manufacturing and have experience writing or contributing to regulatory filings.
• Beneficial Experience: You have experience with scaling cell therapy processes, operations, and activities. Preferably, you also have experience working with pluripotent cells and biomaterials/bioinks.
• Drug Development Knowledge: Advanced knowledge of the drug development process and the interdependencies of individual development activities and projects.
• Computer Skills: Proficiency with MS Office, utilization of PM software (Smartsheet or other Gantting software.