Associate II, Process Development (Bioprinting CMC)

We are seeking an Associate II, Process Development (Bioprinting CMC) to join our high-performing team focused on the manufacturing and process development of bioprinted tissue therapeutics (BTT). In this role, you will support Aspect’s therapeutic programs by assisting in the production of various BTTs, directly contributing to Aspect’s groundbreaking programs and our mission to develop bioprinted tissue therapeutics to transform the lives of people with serious diseases.

Responsibilities

• Support in the manufacturing of BTTs in-vitro and in-vivo for Aspect’s Good Manufacturing Practices (GMP) and research and development goals.
• Prepare materials and reagents for BTT processes in compliance with Good Documentation Practices (GDP).
• Help carry out process optimization and scale up activities to support IND-enabling work for multiple BTT product candidates.
• Perform routine maintenance of bioprinting equipment to support consistent production.
• Assist in developing and testing bioprinting processes and BTTs to meet project goals.
• Follow standard operating procedures (SOPs) and collaborate with process development teams to ensure compliance.
• Ensure compliance of optimization and scaling strategies with cGMP regulations.
• Work closely with R&D, CMC, quality, and regulatory teams to support Bioprinting Design Transfers (BDT) in compliance with regulatory requirements.
• Design and execute studies to qualify and characterize new BTTs.
• Perform data collection and analysis to contribute insights for process improvement.
• Collaborate cross functionally to help develop and refine bioprinting methods for different therapeutic applications.
• Create and follow experimental forms, SOPs, batch production records (BPRs), and other documentation as needed.

Qualifications                                                                         

• Education + Experience: A master’s in biomedical engineering, materials science, biochemistry, life sciences or related field; alternatively, a bachelor’s with at least 2 years of industry experience. 
• Process Development Exposure: Familiarity with biomanufacturing process development, including scale-up and optimization. Experience in a cGMP setting—especially in cell therapy—is a strong asset.
• GMP & GDP Knowledge: Basic understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), with experience working in regulated environments preferred.

Who you are

• Problem Solver: You love immersing yourself in difficult technical problems
  and coming up with solutions that work. You think outside the box and use
  your experience and intuition to identify when such solutions are realistic.
• Detail-Oriented & Meticulously Organized: You have outstanding attention
  to detail and take pride in your work. You can multitask, prioritize competing
  deadlines, and have a track record for delivering work on time.
• Thrive in Ambiguity: You are highly adaptable, agile, and poised when faced
  with change, ambiguity, and competing priorities.
• 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 effectively
  communicate to different audiences in diverse situations.
• Go-Getter: You 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 and do what it takes to get the job done.

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!

The hiring range for this role is $57,000-$82,000, annually. Our ranges are based on market data. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Note that base salary is just one part of the overall compensation at Aspect. Members of the Aspect team also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.