Senior Executive, Bioprocessing & Manufacturing
Location: Vancouver, BC
We are seeking a proactive and results-oriented Senior Executive to advance Aspect’s bioprinted cell therapy production from manufacturing to patient application. Reporting to the CEO, you will oversee and build out Aspect’s clinical and commercial scale GMP for cell therapy manufacturing. You will also be responsible for optimizing and transferring processes from research to manufacturing. Liaising with cross-functional leaders from R&D, Engineering, and Quality, you will establish these processes to ensure Aspect’s bioprinted cell therapies are manufactured to the utmost quality. This includes overseeing process sciences, analytical development, MSAT, early phase clinical manufacturing functions, and final packaging unit operations.
WHAT YOU'LL DO
- Spearhead and execute Aspect’s GMP strategy for bioprinted cell therapies, translating our manufacturing processes from research to production.
- Collaborate cross-functionally to define and achieve quality target product profile.
- Provide technical leadership for the development of scientifically robust, fit-for-purpose processes and CMC strategies for cGMP, including process design and optimization, formulation development, and product relevant materials and characterization.
- Liaise with various internal and external stakeholders to generate and execute preclinical and clinical project plans, including tech transfer, analytical development, process development, and manufacturing.
- Implement phase-appropriate and risk-based studies for the process development and manufacturing of bioprinted cell therapies, including characterization, critical process parameters, optimization, scale-up, and process validation using DoE (Design of Experiments), and QbD (Quality by Design).
- Prepare and present results and progress of process development studies.
- Write, review, and finalize technical reports, SOPs, tech transfer documents and relevant sections of Regulatory Filings.
- Stay up-to-date and continually improve best practices to build and establish cost effective operations, that are stage appropriate, robust, and scalable.
- Provide superior leadership, direction, and management for the manufacturing and process development team.
- Support operational planning and organization, prioritize organization, prioritize projects to ensure Aspect achieves our short- and long-term objectives.
- Develop and maintain all necessary systems and procedures to ensure Aspect’s operations comply with all FDA requirements and meet ISO13485 and cGMP standards.
WHO YOU ARE
- Education: BSc, MSc, or PhD in biochemical engineering, chemical engineering, biological sciences, cell therapy, molecular biology, or similar discipline.
- Professional Experience: 10+ years of progressive leadership experience in cell therapy process development and manufacturing.
- Process Development Experience: Leadership experience in bringing cell therapy equipment and processes from design through to clinical and GMP operations. This includes technology transfer from research to manufacturing between facilities/sites, from/to partners.
- Master of Analytical Methods: You are data driven and use FMEA and other analytical methods to drive cross-functional strategies to address technical challenges and support process development as well as the quality control of cell therapy products.
- Champion in Regulatory Guidelines: Experience writing regulatory submissions, process reports and technical transfer documents and an extensive knowledge base of cGMP and GLP Regulatory Guidelines. You understand the importance of having a strong relationship with Regulatory Authorities (ICH, FDA, EMA, and PDMA).
- Quality Advocate: Committed to establishing an industry leading quality culture, including scientifically robust and data-driven study design and execution, you are committed to compliance and continuous improvement.
- Leader: You lead by example and inspire high performance. You have outstanding organizational and leadership abilities with a demonstrated record of both building and leading world class teams through clinical and commercial scale GMP cell therapy manufacturing.
- Go-Getter: You think strategically, work with a sense of urgency, are results-driven, and thrive in a fast-paced, interdisciplinary, and entrepreneurial environment. You are willing to roll up your sleeves, dig into the details, and do what it takes to get the job done.
WHO WE ARE
Aspect Biosystems is a Canadian biotechnology company combining the power of microfluidics and 3D bioprinting to create bioprinted therapeutics. Our bold team of innovators and entrepreneurs have joined us from all over the globe to move the needle on 3D bioprinting and work towards a future where our technology is used to save lives and make people healthier.
We are endlessly curious and wildly passionate about what we do. Our team is always excited to learn and roll up our sleeves to make a difference in the ever-changing world of biotech. We believe that every person on our team is a key contributor to our success. If you are committed to make a real impact and accelerate the development of biotechnology, we want to hear from you!
The environment at Aspect is fast-paced, collaborative, ever-changing, and supportive. We are looking for team players who bring substantial expertise and competency in their field. We offer competitive compensation packages and benefits with excellent opportunities for personal growth and career development.
We very much appreciate your interest in a position at Aspect and thank all candidates for applying. Only candidates selected for an interview will be contacted.