POSITION OVERVIEW:

The Business Leader & CMC Advisor, Autologous Therapies will spearhead OmniaBio’s autologous 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 autologous products, including CAR-T 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.
As a senior strategic leader, you will combine deep expertise in Chemistry, Manufacturing, and Controls (CMC) with a forward-looking approach to AI and automation, shaping OmniaBio’s business strategy from ideation through execution. Your leadership will empower the development of innovative, efficient, and cost-effective solutions that address key challenges our customers face in allogeneic cell therapy production.
Collaborating closely with cross-functional teams, including Marketing, Business Development, and R&D, you will drive customer engagement, foster strategic partnerships, and support business growth, all while ensuring the highest standards of manufacturing excellence. The Business Leader will report to the Chief Strategy Officer and Head of AI, working closely with both teams to align business and technological strategies.

QUALIFICATIONS & SKILLS:

• 10+ Years Expertise in Autologous Therapies: Proven track record in the development and commercialization of autologous cell therapies, with deep expertise in CMC processes, including (most importantly) CAR-T 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 CAR-T, ex-vivo 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 a keen desire for 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. Willing to learn relevant regulations around the use of artificial intelligence in life sciences/biopharma.
• 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 and/or in the United States. This role is open to remote location within North America and requires a minimum of 30% travel.
  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

• Lead Autologous Business Strategy: Define and execute the strategic roadmap for OmniaBio’s autologous therapies portfolio, with a focus on CAR-T based products and associated 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 continually optimize vein-to-vein time and cost of goods (COGs) related to autologous therapy manufacturing.
• Drive CMC Excellence: Oversee the development and implementation of CMC strategies for autologous products, ensuring efficient and scalable manufacturing processes, regulatory compliance, and high-quality outcomes. Act as a subject matter expert (SME) on CAR-T 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, understand and 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 CAR-T 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 the autologous 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.