At Aspect Biosystems, we are pioneering Bioprinted tissue therapeutics (BTTs), the next frontier in cell-based combination products, that harness the power of cell therapy, biomaterials, bioengineering, and advanced manufacturing to address currently incurable diseases.

We are seeking a Senior Director Process Development and Manufacturing to lead the strategy and execution of process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics. Reporting to senior leadership, this role requires a deep understanding of biopharmaceutical process development, cGMP manufacturing, and regulatory requirements associated with cell-based therapies and combination products. This role will oversee the process development and supply of therapeutic cells, biomaterials, and Bioprinted Tissue Therapeutic products and is ultimately accountable for the successful manufacturing of multiple Bioprinted Tissue Therapeutic drug substances and drug products.

Responsibilities

Provide strategic leadership and technical expertise in the process development and manufacturing of cell-based combination products, ensuring alignment with our company’s vision and regulatory requirements.
Spearhead the design and execution of process development and manufacturing strategies for stem cell culture, differentiation, and integration with biomaterials using our bioprinting manufacturing technology.
Ensure efficient and compliant functioning of BTT manufacturing, including direct responsibility for biomaterial and cellular drug substances as well as BTT (i.e., drug product) manufacturing functions.
Author, review and/or approve process development/transfer/validation study protocols and reports to ensure high quality documentation to support regulatory filings.
Forecast, schedule, and track all manufacturing activities to ensure timely disposition and accountability for Key Performance Indicators.
Lead a team of cross-functional stakeholders to drive strategic decisions into manufacturing execution.
Facilitate alignment with senior leadership and appropriate prioritization within manufacturing priorities.
Enable and communicate a site mission and the strategic direction, business goals, objectives, and priorities.
Foster a culture of flexibility, nimbleness, efficiency, and a strong compliance mindset while promoting positive collaboration among all team members, partners, and key stakeholders.
Ensure processes are transferred, and products are manufactured and delivered in a safe, timely, and financially responsible manner in compliance with FDA, Health Canada, and EMA regulatory requirements.
Analyze operating costs and drive towards efficiency improvement.
Successfully attract, develop, and retain key talent.
Develop and maintain departmental budget.
Present to senior leadership and cross-functional teams across Aspect.
Complete other duties and projects as assigned to meet company goals.

Skills and Abilities

Excellent interpersonal, communication, and organizational skills.
Enthusiasm for learning and growth; proactively identifies opportunities and takes initiative to resolve issues.
Tendency to meet challenges with a problem-solver mindset.
Demonstrated ability to manage concurrent deliverables and work effectively in a dynamic, fast-paced environment.
Ability to work collaboratively as a member of cross-functional teams and to establish and maintain effective working relationships.
Ability to lead by example and to establish an environment fostering effective and collaborative working relationships at all levels of the organization.
Ability to successfully prioritize and manage competing demands.
Ability to refine project plan/timelines to meet critical milestones.
Proficiency with MS Office, utilization of PM software (Smartsheet or other Gantting software).

Qualifications

Education + Experience: PhD with 5+ years or MSc/BSc with 10+ years directly related experience in cell therapy process development and manufacturing, or combination of experience and education.
Manufacturing Expert: Solid performance in managing quality events, such as deviations, CAPA, change controls. Proficient in budgeting, FTE projection and production forecasting.
GMP & Regulatory Knowledge: You are knowledgeable about GMP requirements for biologic or cell manufacturing and have experience writing or contributing to regulatory filings.
Beneficial Experience: You have experience with scaling manufacturing processes, operations, and activities. Preferably, you also have experience working with pluripotent cells and biomaterials/bioinks.
Knowledge: Advanced knowledge of the drug development process and the interdependencies of individual development activities and projects.

Who You Are

Detail-Oriented: You have outstanding attention to detail as well as experimental and process rigor. You take pride in your work and strive for excellence.
Meticulously Organized Planner: You have excellent planning and organizational skills, with the ability to balance production, development, and continuous improvement needs. You can multitask, prioritize competing deadlines, and have a track record for delivering work on time.
Effective Communicator: You are an active listener who can communicate to different audiences in diverse situations.
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 $176,000 - $251,000, 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.

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!

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.

This job is no longer accepting applications

See open jobs at Aspect Biosystems.See open jobs similar to "Senior Director Process Development & Manufacturing" Work In Tech.

See more open positions at Aspect Biosystems

Privacy policy Cookie policy