About Nucleus Biologics:
At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations.
Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability.
About the role
- The Commercial Operations Project Lead will manage and lead cross-functional projects that span custom media formulation, GMP and excipient manufacturing, customer onboarding, product development, and scale-up to meet commercial demand. This role partners closely with technical, regulatory/quality, manufacturing, and commercial teams to ensure projects meet timelines, quality standards, and business objectives.
RESPONSIBILITIES:
- Lead end-to-end project management of commercial project initiatives, including custom media/buffer launches, scale-up manufacturing runs, and customer onboarding.
- Collaborate across departments (R&D, quality/regulatory, manufacturing, supply chain, sales/business development) to ensure seamless execution of manufacturing projects.
- Develop, maintain, and own project documentation: project plans, Gantts/timelines, milestones, risk assessments, stakeholder communications, status reports, and post-launch reviews.
- Ensure all projects align with the company’s quality and regulatory standards, leveraging Nucleus Biologics’ ISO 13485, Excipient GMP / EXCiPACT certified systems.
- Identify bottlenecks in commercial operations workflows (e.g., order fulfillment, manufacturing scheduling, supply-chain coordination) and propose process improvements to increase efficiency, reduce turnaround time, and improve customer satisfaction.
- Support business development team with technical inquiries and strategic bids for external projects and manage customer relationships.
- Facilitate effective communication and coordination with external customers (biotech, cell and gene therapy developers), contract development/manufacturing organizations (CDMOs) and internal stakeholders to ensure alignment and timely delivery.
REQUIREMENTS:
EDUCATION:
- Bachelor’s degree in Business, Operations, Life Sciences, Biotechnology Management or a related field. Advanced degree (MBA, MS in Biomanufacturing/Regulatory Affairs) is a plus.
REQUIRED EXPERIENCE:
- 2-5+ years of project management or operations management experience — ideally in biotech/pharmaceutical/CGT or life-sciences manufacturing environment.
- Strong understanding or exposure to cell therapy and gene therapy manufacturing, cell culture media/buffers/reagents production, GMP requirements, regulatory compliance, or supply-chain for biologics is a strong advantage.
- Proven track record of delivering complex, cross-functional projects on time and within scope, in regulated environments.
- Excellent communication, stakeholder management, and collaboration skills — able to coordinate across scientific, operational, regulatory, and commercial teams as well as with external stakeholders.
- Proficiency with project management tools (e.g., Asana, Smartsheet, Microsoft Project, or equivalent) and familiarity with documentation/control systems (Quality Management Systems -QMS) common in GMP/life-sciences settings.
- Analytical mindset, comfort with data, able to define and monitor KPIs, identify inefficiencies or process gaps, and recommend improvements.
- Ability to adapt in a fast-growing, dynamic environment — comfortable with ambiguity, scaling operations, and rapid change.
- Strong attention to quality, detail, and compliance standards.
SKILLS & ABILITIES:
- Deep appreciation for the mission-driven nature of CGT balancing scientific rigor, manufacturing quality, and commercial impact.
- Strategic thinker with operational execution ability to translate business goals into actionable operational plans.
- Cross-functional collaborator who can lead without direct authority while fostering alignment across departments.
- Problem-solver with a proactive mindset to anticipate challenges, manage risks, and navigate complex regulatory/quality constraints.
- Resilient and organized, with strong time management, communication, and prioritization skills.
PHYSICAL REQUIREMENTS:
- Ability to hear and speak to employees and external associates on the phone and in person.
- Ability to see the letters and numbers on a personal computer screen and on memos, reports, and other documents (near vision)
- Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego-based positions
- Ability to lift at 25 lbs. to a height of 3-4 feet on a regular basis.
TRAVEL REQUIREMENTS:
- May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position.
NOTE: The above statements describe the general nature and level of work being performed. They are not an exhaustive list of all responsibilities, duties, or skills required. Duties may change at any time, and reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
