We are looking for an enthusiastic Scientist to join our Quality Control & Analytical Development team in Fremont, California. In this role, you will be a subject matter expert in and cell-based analytical methods, supporting the development, optimization, and qualification of assays used to characterize our bioprinted tissue therapeutics. Reporting to our Head, Quality Control and Analytical Development, you'll play a critical role in establishing robust analytical methods while partnering closely with QC, Process Development, and Research as programs advance toward clinical readiness.

Responsibilities 

• Leading the end-to-end development and optimization of complex bioanalytical methods, such as ddPCR, qPCR, and flow cytometry. 
• Thorough execution of cell-based assays and ELISAs, ensuring all analytical platforms meet the highest standards of precision, scalability, and regulatory compliance.
• Designing and executing analytical experiments to support product characterization, comparability, and process understanding for raw materials, in-process samples, and drug products.
• Participating in and executing experiments for the qualification and validation of analytical methods, contributing experimental data, protocols, and technical expertise.
• Performing routine analytical testing as needed to support process development, product characterization, and early-stage stability studies.
• Accurately record, analyze, interpret, and present experimental data. Author and review technical reports, study protocols, and standard operating procedures (SOPs) in compliance with GxP principles.
• Identifying and troubleshoot analytical method issues, propose solutions, and implement corrective actions.
• Acting as a subject matter expert, advising cross-functional teams on assay design, controls, and data interpretation.
• Working cross functionally with Process Development, Quality Control, Research & Development, and Manufacturing to support product development milestones and resolve analytical challenges.
• Performing routine maintenance and calibration of analytical instruments and ensuring proper functioning.
• Adhering to and contributing to the development of robust analytical quality systems, ensuring data integrity, traceability, and compliance with internal and external regulations.
• Other duties as required. 

Qualifications & Experience

• Education & Experience: Bachelor's or Master's degree in a relevant scientific discipline with 3+ years of relevant experience in analytical development within the biotechnology or pharmaceutical industry with hands-on experience in cell therapy, gene therapy, or combination products. 
• Analytical Expertise: Proven hands-on experience with a range of analytical techniques, such as flow cytometry, ELISA, and/or cell-based assays.
• GxP Knowledge: Familiarity with GxP principles (GLP, GMP) and an understanding of regulatory expectations for analytical method development, qualification, and validation for biologics or advanced therapies.
• Problem-Solver: You have a keen eye for detail and a methodical approach to troubleshooting analytical challenges.
• Innovation Mindset: You're eager to learn new techniques and contribute to the continuous improvement of analytical processes.

The hiring range for this role is $90,000 - $96,300, annually. Our pay scales are based on market data to ensure that compensation is competitive and fair. 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. Base salary is just one part of the overall compensation at Aspect, team members also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.

We are seeking a Supply Chain Lead to join our technical operations team. This is a leadership role responsible for the end-to-end integrity of our supply chain, encompassing strategic procurement, warehouse operations, and complex logistics for our bioprinted tissue therapeutics. Reporting to the Chief Technical Operations Officer, you will be accountable for building a scalable, GMP-compliant materials management framework that supports our transition from research through to clinical manufacturing.

Responsibilities

• Design and execute a comprehensive supply chain strategy that ensures material availability for R&D, New Product Introductions (NPIs), and clinical production.
• Establish and oversee phase-appropriate, GMP/GDP-compliant warehousing and inventory control systems, ensuring adherence to safety and regulatory protocols.
• Lead strategic purchasing operations, including vendor selection, contract negotiation, and the development of a resilient supplier network to mitigate lead-time risks.
• Serve as the functional owner for the ERP system, driving optimization initiatives, data integrity, and cross-departmental training to ensure seamless digital workflows.
• Implement advanced tracking and predictive analytics to optimize inventory levels, reduce waste/expirations, and manage the materials budget in partnership with Finance.
• Oversee all inbound and outbound logistics, ensuring the cold chain integrity and secure transport of sensitive biological materials and finished products.
• Maintain documentation for regulatory inspections (FDA, EMA, Health Canada) and lead materials-related investigations, deviations, and CAPAs.
• Partner with Manufacturing, Quality, and R&D to ensure production readiness and provide technical expertise for technology transfers.
• Directly execute all daily warehouse operations, serving as the primary hands-on resource for receiving, picking, packing, and physical inventory management. 

Qualifications & Experience 

• Expert knowledge of Good Manufacturing Practices and Good Distribution Practices for sensitive biological materials.
• Experience as a functional lead or power user for ERP software (e.g., SAP, NetSuite, or Oracle). Experience optimizing the workflows and ensuring data integrity.
• Technical understanding of temperature-controlled shipping and storage, specifically for cell therapies or biologics.
• 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.
• You have outstanding attention to detail as well as experimental and process rigour. You take pride in your work and strive for excellence.
• Proven ability to pivot between high-level strategic planning and tactical, hands-on execution; must be comfortable performing physical labor, including the ability to lift and move materials up to 50 lbs [~23 kg] on a regular basis. 

The hiring range for this role is $132,000 - $140,000, annually. Our pay scales are based on market data to ensure that compensation is competitive and fair. 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. Base salary is just one part of the overall compensation at Aspect, team members also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.

We're looking for a highly motivated Senior/Lead Engineer to join our dynamic Technical Operations team in Fremont, California. Reporting to the Chief Technical Officer, you will be instrumental in evolving our GMP processes and instrumentation for clinical manufacturing. You’ll be joining a company committed to developing regenerative medicines that deliver life-changing, functional cures for patients living with serious diseases. 

Responsibilities

• Owning the site-wide metrology program, ensuring all instrumentation is calibrated, maintained, and performing within established tolerances to support a validated state of operation.
• Leading the commissioning and qualification (C&Q) of systems for pre-clinical and clinical cell therapy manufacturing, applying risk-based strategies. Ensure all systems meet GAMP5 and Data Integrity standards.
• Generating and defending lifecycle documentation, including System Impact Assessments, URS, FMEAs, and IQ/OQ/PQ protocols. Standardize and improve business processes for equipment intake, periodic reviews, and change control to increase site efficiency and compliance.
• Serving as the primary engineering partner for R&D and Manufacturing during the design and modification of new systems, participating in design reviews and technology transfers.
• Successfully defend engineering and validation packages during internal and regulatory inspections (FDA, EMA, Health Canada), serving as the Subject Matter Expert (SME) for equipment reliability and data integrity.
• Directing resource allocation and test scheduling for complex engineering projects, ensuring timelines are met without compromising quality or safety.
• Implementing an effective Maintenance Management System including asset registry, PM schedule, work order tracking, replacement parts inventory and tracking, and metrology and calibration tracking. Lead root-cause investigations into equipment failures. 

Qualifications                                                                         

• Education & Experience: You hold a Bachelor's or Master's in Engineering or another relevant discipline and 6-8+ years of progressive experience. 
• You have demonstrated success in leading complex technical projects and providing mentorship to junior team members.
• Engineering Lifecycle & C&Q Leadership: Extensive experience leading Risk-Based Commissioning and Qualification (C&Q) for cell therapy manufacturing, including the generation and defense of URS, FMEA, and IQ/OQ/PQ protocols in compliance with GAMP5 and Data Integrity standards.
• Metrology & Asset Management: Proven track record owning site-wide metrology and maintenance programs, including the implementation of CMMS for asset tracking, PM scheduling, and root-cause investigations within a validated FDA/EMA/Health Canada regulated environment.
• 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.

The hiring range for this role is $128,452 - $136,000, 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.

We are seeking a highly motivated Site Operations Manager to join our team in Fremont, California. As the Site Operations Manager, you will play a vital role in ensuring the smooth operation of our laboratories, maintaining the safety and integrity of our facilities, and supporting our scientists in their mission to the clinic. You’ll be joining a company committed to developing regenerative medicines that deliver life-changing, functional cures for patients living with serious diseases. 

Responsibilities

• Coordinating with external vendors, managing service contracts for waste disposal, and specialized facility repairs (electricity, water, HVAC, etc.)
• Supporting EHS and Compliance programs, ensuring the site meets local fire codes, OSHA standards, and environmental regulations. Maintain organized records for all facility inspections and supply chain documentation.
• Monitoring operational budgets, tracking spend on utilities, supplies, and shipping costs as well as overseeing vendor relationships, troubleshooting issues and presenting optimization recommendations while ensuring budget alignment. 
• Developing and implementing comprehensive facility management strategies, policies, and procedures specific to laboratory operations, safety, utility management, and procurement in alignment with our companywide operation strategy.
• Providing technical input to purchasing and other functional areas. Responsible for development of tracking procedures, establishment and maintenance of service contracts and warranties with vendors. 
• Owning the Procurement lifecycle, from vetting new vendors and negotiating service level agreements (SLAs) to processing purchase orders and resolving billing discrepancies to maintain healthy supplier relationships
• Establish and facilitate an environment that supports our fast-paced, mission-driven team, to do their best work each day, with a particular focus on operational excellence, continuous improvement, and a thriving workplace culture.

Qualifications & Experience

• Education & Experience: You hold a Bachelor's or Masters degree in Life Sciences, Engineering or another relevant discipline and 4-6+ years of progressive experience as a leader within a biotech, pharmaceutical, or scientific R&D environment. 
• Knowledge: Proven expertise in managing the end-to-end logistics of temperature-sensitive biological materials, including the execution of LN2/Dry Ice protocols and the validation of calibrated data loggers.
• You have demonstrated success in supporting multidisciplinary teams and managing large-scale initiatives.
• You are experienced in overseeing lab-specific infrastructure (HVAC, MEP, gas manifolds) and ensuring continuous site compliance.
• You have hands-on experience as a functional lead for ERP/Inventory systems, with the technical ability to build and maintain Bills of Materials (BOM), part-numbering schemas, and real-time stock tracking.
• You thrive in a multi-disciplinary team environment and believe that we can get further, faster by working together.
• You are highly adaptable, agile, and poised when faced with change, ambiguity, and competing priorities.

The hiring range for this role is $132,000 - $140,000, annually. Our pay scales are based on market data to ensure that compensation is competitive and fair. 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. Base salary is just one part of the overall compensation at Aspect, team members also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.

We are seeking a highly motivated and detail-oriented Manufacturing Technician to join Aspect’s Technical Operations team. You will be responsible for the preparation, formulation, and in-process testing of biomaterials used across all of Aspect’s bioprinted tissue therapeutic programs. This role is critical to ensuring consistent and high-quality biomaterial supply to enable preclinical research, process development, and manufacturing activities.

Responsibilities

• Perform end-to-end biomaterial production, including formulation, compounding, filtration, and aliquoting, under standardized protocols and cGMP guidelines.
• Prepare and operate manufacturing equipment and instrumentation used in biomaterial preparation.
• Maintain accurate and detailed batch records, logs, and production documentation in accordance with Standard Operating Procedures (SOPs) and quality standards.
• Collaborate with R&D and Quality teams to onboard new materials and processes.
• Support inventory management and ordering of raw materials, reagents, and consumables required for biomaterials manufacturing.
• Provide materials for in-process quality checks and quality control tests to ensure batch conformity and sterility.
• Perform filter integrity tests and other tests to verify equipment and process integrity.
• Monitor and report any deviations, non-conformances, or equipment malfunctions promptly to the supervisor.
• Participate in cleaning, calibration, and routine maintenance of production equipment, and process qualification as needed.
• Follow aseptic and cleanroom best practices to ensure material integrity and contamination control.
• Identify and propose improvements to process efficiency, material consistency, and documentation practices.
• Ensure a safe working environment by following all health and safety procedures and contributing to hazard assessments.

Qualifications & Experience

• Education + Experience: 1–2 years of hands-on experience in a regulated environment or manufacturing environment, preferably in biomaterials, biologics, or pharmaceutical production.
• Technical Knowledge: Familiarity with laboratory equipment, formulation techniques, and aseptic/cleanroom practices.
•  Intellectually Curious: You have a burning desire to learn more and aren’t afraid to ask questions.
• 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.

The hiring range for this role is $50,000 - $60,000 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.

We're looking for a highly motivated Senior Process Engineer to take on an important role in our dynamic and dedicated Process Development team. Reporting to the Head of Process Development, you will work on developing an aseptic manufacturing workflow for our bioprinted tissue therapeutics. You’ll be joining a company committed to developing regenerative medicines that deliver life-changing, functional cures for patients living with serious diseases. 

Responsibilities 

• Leading the conceptualization, design, implementation and characterization of complex fluidic systems, bioreactor scaling strategies, and automated cell processing workflows (wash, concentrate, harvest) to reduce process risk and improve robustness.
• Working with Process Development, Bioengineering, Engineering and Manufacturing to ensure seamless technical integration of the cell therapy process into the final device platform, focusing on closed-system design and single-use technologies.
• Leading process risk assessments (e.g., FMEA, PHA) for both the cell manufacturing process and its interaction with the medical device component.
• Developing mathematical models and implementing approaches such as DOE (Design of Experiments) to help define critical process parameters (CPPs) and critical quality attributes (CQAs).
• Supporting technology transfer to Manufacturing including support for process qualification as well as assisting in early phase clinical manufacturing as needed.
• Providing technical support for troubleshooting and participating in out-of specification and root cause analysis during manufacturing deviations or process improvements.
• Working with our Quality team to define the validation strategies for sterilization, biocompatibility, and extractables/leachables (E&L) as well as providing the technical backbone for regulatory filings (CTA/IND).
• Identifying gaps in current cell therapy manufacturing and developing patentable technologies to improve yield, purity, and scalability.
• While an individual contributor role, you will mentor others and foster a culture of technical excellence and rigorous data-driven decision-making.

Qualifications & Experience

• Education + Experience: M.S. or Ph.D. in Chemical Engineering, Bioengineering, Biomedical Engineering, or a related life science field with 6-8+ years of relevant industry experience, in cell therapy, bioprocess development, or biologics manufacturing.
• Knowledge: Strong hands-on background in the development, characterization, and optimization of biomanufacturing processes is required, preferably within cell therapy. 
• You have expertise in the design, implementation, and characterization of complex fluidic systems, including automated cell processing workflows (e.g., wash, concentrate, harvest). Proven ability to develop mathematical models and apply statistical methods (such as Design of Experiments, or DOE) for process characterization and defining Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). Experience with bioreactor systems and scaling strategies is desirable.
• You have thorough knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Familiarity with regulatory requirements for cell therapy products (e.g., providing technical content for CTA/IND filings).
• You have strong analytical, problem-solving, and data-driven decision-making skills. Excellent written and verbal communication skills, including the ability to present complex data and mentor junior team members.
• You thrive in a multi-disciplinary team environment and believe that we can get further, faster by working together.
• You are an active listener who can effectively communicate to different audiences in diverse situations. 

The hiring range for this role is $124,737 -  $131,689 CAD 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.

We are looking for an enthusiastic, experienced Engineer to join our team in Fremont. Reporting to the Senior Engineer, you will provide essential technical support for the Fremont site’s metrology program and facility operations. This role is a mix of hands-on technical execution and project coordination, ensuring that manufacturing equipment and site utilities (HVAC, electrical, and mechanical) are calibrated, maintained, and compliant with site standards. You will be directly contributing to our groundbreaking programs and our mission to develop bioprinted tissue therapeutics to transform the lives of people with serious diseases.

Responsibilities

• Executing the site-wide metrology program, coordinating the calibration and maintenance of all instrumentation to ensure systems remain within established tolerances and support a validated state of operation.
• Supporting the Commissioning, Qualification, and Validation (CQV) of manufacturing equipment and facility utilities (HVAC, water, and gas systems) under the guidance of the Senior Engineer, applying risk-based strategies and GAMP5 standards.
• Drafting and maintaining lifecycle documentation, including URS, FMEAs, and IQ/OQ/PQ protocols. Assisting in the standardization of equipment intake processes and periodic reviews to increase site efficiency.
• Coordinating with the Manufacturing team during the installation and modification of new systems, acting as a technical resource for equipment design reviews and technology transfers.
• Monitoring facility operations and utilities as well as supporting the maintenance of HVAC and mechanical systems to ensure cleanroom environments and production areas meet performance specifications.
• Managing and handling facility gas systems, including under GMP requirements (daily checks, inventory control of gas cylinders/spares, physically changing/replacing cylinders, etc).
• Assisting in regulatory inspection readiness by organizing engineering and validation packages (FDA, EMA, etc.) and acting as a secondary Subject Matter Expert (SME).
• Administering the Maintenance Management System (CMMS), BMS, FMS, performing data entry and tracking for the asset registry, PM schedules, and replacement parts inventory. Assisting in root-cause investigations for equipment failures or out-of-tolerance events will be among your duties. 
• Facilitating vendor management and test scheduling, ensuring third-party contractors complete calibrations, repairs, preventive maintenance, equipment install, and external IQ/OQ testing on time and in compliance with site safety, quality, and Good Documentation Practice (GDP) standards.
• Overseeing the security of site, facility maintenance and cleaning of controlled and non-controlled areas.
• Creating and maintaining accurate documentation, SOPs, and records for calibrations, maintenance, facility, and utilities. 
• Other duties as required.

Qualifications & Experience

• Experience & Education: A bachelors or masters in engineer and 3–5 years of experience in a regulated industry (Biotech, Pharma, or Med Device), with a strong preference for experience in metrology or facility engineering. We will consider applicants with a mix of industry and educational background.
• Skills: Knowledge of NIST standards, HVAC, Utility Systems (including WFI, gases), and the ability to coordinate multiple vendor schedules simultaneously.
• You have familiarity with reading and interpreting P&IDs, drawings, specifications also, reviewing turnover packages, vendor documentation.
• You have familiarity with conducting or coordinating FAT and SAT testing
• 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.
• You have outstanding attention to detail as well as experimental and process rigour. You take pride in your work and strive for excellence.

The hiring range for this role is $94,000 - $102,000, 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.

We're looking for a Scientist, Analytical Development to join Aspect's technical operations team. In this role, you'll be instrumental in developing, optimizing, and qualifying analytical methods that support our cutting-edge bioprinted tissue therapeutics. Reporting to a Head, Quality Control and Analytical Development, you'll play a crucial part in ensuring the quality and characterization of our innovative products as we advance toward clinical development.

Responsibilities 

• Design, execute, and optimize a variety of analytical methods (e.g.cell-based assays, bioanalytical and flow cytometry methods) for the characterization, release, and stability testing of raw materials, in-process samples, and final drug products.
• Participate in and execute experiments for the qualification and validation of analytical methods in accordance with phase-appropriate regulatory guidelines (e.g., ICH, FDA, Health Canada, EMA).
• Perform routine analytical testing as needed to support process development, product characterization, and early-stage stability studies.
• Accurately record, analyze, interpret, and present experimental data. Author and review technical reports, study protocols, and standard operating procedures (SOPs) in compliance with GxP principles.
• Identify and troubleshoot analytical method issues, propose solutions, and implement corrective actions.
• Work cross functionally with Process Development, Quality Control, Research & Development, and Manufacturing to support product development milestones and resolve analytical challenges.
• Perform routine maintenance and calibration of analytical instruments and ensure proper functioning.
• Adhere to and contribute to the development of robust analytical quality systems, ensuring data integrity, traceability, and compliance with internal and external regulations.

Qualifications & Experience

• Education & Experience: Bachelor's or Master's degree in a relevant scientific discipline with 3-5 years of relevant experience in analytical development within the biotechnology or pharmaceutical industry with hands-on experience in cell therapy, gene therapy, or combination products. 
• Analytical Expertise: Proven hands-on experience with a range of analytical techniques, such as flow cytometry, ELISA, and/or cell-based assays.
• GxP Knowledge: Familiarity with GxP principles (GLP, GMP) and an understanding of regulatory expectations for analytical method development, qualification, and validation for biologics or advanced therapies.
• Problem-Solver: You have a keen eye for detail and a methodical approach to troubleshooting analytical challenges.
• Innovation Mindset: You're eager to learn new techniques and contribute to the continuous improvement of analytical processes.

The hiring range for this role is $90,000 - $96,300, annually. Our pay scales are based on market data to ensure that compensation is competitive and fair. 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. Base salary is just one part of the overall compensation at Aspect, team members also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.

Thank you for your interest in joining Aspect Biosystems! This job posting serves as a general application for candidates who are eager to explore opportunities with our company. By submitting your application here, you're expressing your interest in potential future roles with Aspect Biosystems.

We're always on the lookout for talented individuals who share our passion for innovation and are excited about the possibility of contributing to our mission to transform the treatment of disease with bioprinted tissue therapeutics. While there may not be specific openings available at the moment, we encourage you to submit your application so we can keep your information on file for future opportunities that align with your skills and experience.

Please note that submitting your application through this posting does not guarantee immediate consideration for a specific position. However, it allows us to review your profile and reach out to you when relevant opportunities arise.

Thank you again for considering Aspect Biosystems as a potential employer. We look forward to reviewing your application and potentially welcoming you to our team in the future!