Process Development Manager, GMP Cells
Aspect Biosystems
Vancouver, BC, Canada
Posted on Thursday, October 26, 2023
We are seeking a Process Development Manager, GMP Cells to join Aspect’s GMP Cells team. In this role, you will focus on supplying multiple cell substrates across Aspect’s GMP and Research &Development Groups. You will drive process optimization and scale up to enable progress toward IND submission for multiple Bioprinted Therapeutic Tissue product candidates.
Responsibilities
- Collaborate with internal and external resources to develop qualification strategies for incoming primary and pluripotent cells.
- Leadership responsibility for the overall performance of the team including metric development to measure progress toward objectives and key results (OKRs), adherence to budget, adherence to cGMPs where applicable and development of CMC content to support IND submissions.
- Design and execute studies to assess islet (and other cell types) viability and function in vitro, including the development of quantitative measures for cell viability and potency.
- Develop and execute cell substrate process optimization and characterization projects to achieve specific project and company milestones.
- Optimize and scale processing of therapeutic cells for bioprinting.
- Ensure compliance of optimization and scaling strategies with cGMP regulations.
- Work with Aspect’s R&D and Engineering teams to generate, optimize and characterize bioprocessing processes which are suitable for specific therapeutic indications.
- Ensure proper cGMP compliant documentation of primary/stem cell manufacturing and biomaterial development activities.
- Ensure compliance with Good Documentation Practices (GDP) for all process documents.
- Provide technical leadership and direction to the GMP Cells team.
- Develop a team wide Professional Development strategy.
- Develop training activities on new technologies and processes as needed.
- Ensure team training levels exceed 90% of required SOPs and policies.
- Mentor GMP Cells staff including training and management of development projects.
- Working with Quality Assurance, lead the compliant transfer of new materials and processes into GMP Cells.
- Represent GMP Cells team in cross functional development, optimization or troubleshooting activities.
- Other duties as assigned.
Qualifications
- Education: Bachelor’s or Master’s degree in life sciences or engineering.
- Professional Experience: 5 years of experience in a cGMP setting OR 3 years industry experience + an advanced degree in life sciences/engineering.
- Extensive experience in cell bioprocessing including process optimization, process closure, and process automation.
Who You Are
- Detail-Oriented: You have outstanding attention to detail as well as experimental and process rigour. You take pride in your work and strive for excellence.
- Meticulously Organized: You can multitask, prioritize competing deadlines, and have a track record for delivering work on time.
- Collaborative: You thrive in a multi-disciplinary team environment and believe that we can get further, faster by working together.
- Effective Communicator: You are an active listener who can communicate to different audiences in diverse situations.
- Experienced Leader: You have a proven track record in leading a team with demonstrated ability to develop and motivate high performing teams.
- Critical Thinker: You excel at evaluating complex challenges, seeking input from different sources, and confidently making well-informed decisions.
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!
Why Aspect?
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.
At Aspect Biosystems, we celebrate diversity and are committed to creating an inclusive environment for all employees. All aspects of employment including the decision to hire, promote, discipline, or terminate, will be 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.