Vice President, Vertical Leader & CMC Advisor, Allogeneic Therapies
Description
The Business Leader & CMC Advisor, Allogeneic Therapies will spearhead OmniaBio’s allogeneic cell therapy business, driving go-to-market (GTM) initiatives for our CDMO business. The GTM will define the necessary differentiators and influence the market buyers and stakeholders on scalable manufacturing solutions for allogeneic products, including iPSC-based therapies. This role is critical in positioning OmniaBio as an industry leader at the intersection of cell and gene therapies (CGT), artificial intelligence (AI), and advanced manufacturing technologies such as robotics and automation.
- Lead Allogeneic Business Strategy: Define and execute the strategic roadmap for OmniaBio’s allogeneic therapies portfolio, with a focus on iPSC-based products and cutting-edge manufacturing solutions that leverage AI, automation, and robotics. Understand key challenges customers face, develop and build strategies to overcome the challenges, and collaborate with the business development team to reduce time and cost of goods (COGs) related to allogeneic therapy manufacturing.
- Drive CMC Excellence: Oversee the development and implementation of CMC strategies for allogeneic products, ensuring efficient and scalable manufacturing processes, regulatory compliance, and high-quality outcomes. Act as a subject matter expert (SME) on iPSC technologies, offering technical guidance and thought leadership to teams working on process and analytical development, technology transfer and GMP manufacturing.
- Champion Innovation in AI & Automation: With the support of our AI and automation engineering team, leverage the latest advancements in artificial intelligence, robotics, and process automation to enhance manufacturing efficiency, product consistency, and scalability in the production of allogeneic therapies.
- Industry Thought Leadership: Serve as a thought leader within the CGT industry, keeping OmniaBio at the forefront of scientific, regulatory, and market developments. Influence the future direction of cell therapies through innovative insights and strategic initiatives. Represent OmniaBio at key industry conferences, workshops, and author publications, contributing to the organization’s standing as a thought leader in the iPSC and CGT fields.
- Business Development & Customer Engagement: Jointly with our BD team, lead direct interactions with customers and collaborators, helping to develop and expand relationships. Guide negotiations, close strategic partnerships, and ensure customer satisfaction while driving business growth. Provide technical and strategic business input during contract negotiations, ensuring alignment with customer requirements and facilitating the development of work plans, project budgets, and service contracts.
- Cross-Functional Collaboration: Partner closely with Marketing, Business Development, and R&D teams to align and prioritize strategy, ensure successful execution, and capture market opportunities. Act as a bridge between technical, business, and operational teams to drive cohesive growth.
- Intellectual Property: Lead allogeneic IP strategy, guiding patent filings, internal IP processes, and contractual agreements. Provide strategic advice on IP-related matters to ensure protection and commercialization of OmniaBio’s innovations.
- 10+ Years Expertise in Allogeneic Therapies: Proven track record in the development and commercialization of allogeneic cell therapies, with deep expertise in CMC processes, including iPSC-based products.
- Educational Background: PhD or Master’s degree in bioengineering, chemical engineering, bioprocessing, biotechnology, cell biology, immunology, organic chemistry, or a related discipline.
- Cell & Gene Therapy Expertise: In-depth knowledge of iPSCs, gene editing, and related technologies, with a proven track record in process development, manufacturing, and product characterization.
- Advanced Knowledge of AI & Automation: Strong understanding of how AI, robotics, and automation are transforming biomanufacturing, with experience in implementing these technologies in a therapeutic or biotech context.
- Business Acumen: Experience leading business strategy and development within the CGT or biopharma industries, with a focus on customer acquisition, relationship management, and revenue growth.
- Leadership & Influence: Demonstrated ability to lead cross-functional teams, collaborate with key stakeholders, and influence senior leadership to achieve company goals.
- Strategic Vision & Execution: Ability to define long-term strategies while driving day-to-day execution, ensuring alignment with organizational objectives and delivering measurable business results.
- Regulatory & Compliance Knowledge: Strong understanding of GMP, ICH guidelines, and relevant FDA regulatory frameworks applicable to cell and gene therapies.
- Industry Reputation: An established international reputation within the cell and gene therapy community, with a network of industry contacts and recognition for significant contributions.
OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.
Applicants must be legally eligible to work in Canada.
An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.
OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.