Vice President, Process Development & Manufacturing

We are seeking a Vice President, 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 the Chief Technical Operating Officer, 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 drug substances and drug products for multiple Bioprinted Tissue Therapeutics.

Responsibilities

Provide strategic, efficient, high-quality 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.

Directly manage the Process Development and Manufacturing teams and be accountable for ongoing high-quality delivery or work and effectiveness of the teams.

Forecast, schedule, and track all manufacturing activities to ensure timely disposition and accountability for Key Performance Indicators, ensuring alignment with Company objectives directly and through the management of others.

Provide input to the overall Technical Operations strategies and operational planning.

Lead a team of cross-functional stakeholders to drive strategic decisions into manufacturing execution.

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.

Facilitate alignment with senior leadership and appropriate prioritization within manufacturing priorities.

Liaise with various internal and external stakeholders to generate and execute preclinical and clinical project plans, including tech transfer, analytical development, process development, and manufacturing.

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.

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.

Excellent people manager with proven experience leading highly engaged teams.

Thorough knowledge of industry practices and standards; experience driving process improvements and best practices.

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 15+ years or MSc/BSc with 20+ years directly related experience in process development and manufacturing, with experience in cell therapy.

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 - $271,000, 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.

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