Vancouver, BC, Canada
Posted on Tuesday, August 22, 2023
We are seeking a Head of Manufacturing to lead multi-product production of investigational bioprinted tissue therapeutics (BTTs). This role oversees compliant BTT production, team training, and cross-functional solutions. Reporting to the Senior VP for Manufacturing and Process Development, you will lead internal teams and collaborates on strategic initiatives. This role ensures seamless supply of pre-clinical and BTT products and is ultimately accountable for the successful manufacturing of multiple BTT drug substances and drug products.
WHAT YOU’LL DO
- Ensure efficient and compliant functioning of BTT manufacturing, including direct responsibility for drug substance and drug product manufacturing functions.
- 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 Aspect 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, EMEA, and Rest of World (ROW) 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.
- Become process subject-matter expert and work with process development and manufacturing teams to ensure technical compliance and adherence is maintained.
- Complete other duties and projects as assigned to meet departmental requirements.
WHO YOU ARE
- Education: BSc with 10+ years directly related experience in cGMP cell manufacturing environment, or combination of experience and education.
- Beneficial Experience: You have experience with scaling manufacturing processes, operations, and activities. Preferably, you also have experience working with pluripotent cells and biomaterials/bioinks.
- GMP & Regulatory Knowledge: You are knowledgeable about GMP requirements for biologic or cell manufacturing and have experience writing or contributing to regulatory filings.
- Manufacturing Expert: Solid performance in managing quality events, such as deviations, CAPA, change controls. Proficient in budgeting, FTE projection and production forecasting.
- 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
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 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.