Associate Ii, Quality Control
4 months ago
**Responsibilities**:
- Support studies to assess iPSC β cell aggregates, primary pancreatic islets, primary hepatocytes, and cell lines (Min6, Ins1, HepG2, etc.) viability in vitro and ex vivo including the development of quantitative measures for cell viability, purity, and potency.
- Execute routine analytical assays such as ELISA, fluorescent microscopy, qPCR, flow cytometry, cytotoxicity, osmolality, viscosity, purity, rheology and other QC Analytics functions as needed.
- Execute raw material testing and aid in the further development of the raw material testing program in coordination with quality assurance and other stakeholders.
- Participate in assay development and validation activities for R&D and manufacturing purposes.
- Support the transfer of analytical assays out of and into the QC Analytics team.
- Participate in laboratory and product excursion investigations (Alert, Action, and Out of Spec/Out of Trend) in coordination with Quality Assurance.
- Conduct peer review of analytical data, maintain data trending records, and execute statistical process control methods to evaluate cells, clusters, islets, and bioprinted tissue therapeutics throughout the manufacturing process.
- Support development and execution of drug substance/product process optimization and characterization projects to achieve specific project and company milestones.
- Support the production and assessment of bioprinted tissue therapeutics to Aspect’s R&D and Manufacturing groups. Duties may include equipment readiness and maintenance as well as product monitoring.
- Perform laboratory-based studies to qualify biocompatible materials for incorporation into bioprinted pancreatic tissues.
- Work with the Aspect’s Manufacturing, R&D, and Engineering teams to generate, optimize, and characterize analytical assays which are suitable for specific tissues/indications.
- Execute cGMP compliant documentation of analytical assays, primary/stem cell manufacturing, and biomaterial development activities in compliance with Good Documentation Practices (GDP).
**Qualifications**:
- ** Education Experience**:Master’s degree in life sciences or engineering with 2+ years of industry experience and/or a BSc with 5+ years of industry experience.
- ** Professional Experience. **This position will require moderate experience in assay development in a GLP/GDP environment.Additional experience in aseptic mammalian cell culture, protein expression and quantification assays (ELISA, multi-colour flow cytometry), assay/method development and troubleshooting, maintaining GLP/GDP practices, and the ability to analyze datasets to interpret and communicate findings to management and other key stakeholders are critical to the current position.
**Who You Are**:
- Intellectually Curious: You have a burning desire to learn more and aren’t afraid to ask questions.
- 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
**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 caree
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