VP, Manufacturing

The Vice President, Manufacturing provides strategic and operational leadership for the Company’s manufacturing organization, including GMP Manufacturing, Supply Chain, and Manufacturing Science and Technology (MSAT). This role is accountable for reliable clinical and commercial supply of autologous induced pluripotent stem cell (iPSC)-derived cell therapy products by establishing scalable manufacturing operations, resilient supply chain systems, and science-based process optimization. The Vice President leads commercial readiness, manufacturing capacity and investment strategy, technology transfer, process lifecycle management, and operational excellence while ensuring quality, compliance, safety, cost, and delivery objectives are met. As a member of the Technical Operations leadership team, the role partners closely with Quality, Regulatory Affairs, Clinical Operations, Facilities and Engineering, Finance, Research, and external manufacturing and supply partners. This is an on-site role in Torrey Pines, CA that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.

DUTIES AND RESPONSIBILITIES:

• Lead manufacturing strategy and execution for clinical and commercial production of autologous iPSC-derived cell therapy products.
• Direct GMP Manufacturing, Supply Chain, and MS&T, aligning functional objectives, operating plans, and resources with corporate priorities, product-development timelines, and commercial-readiness requirements.
• Build, develop, and lead a high-performing technical operations organization capable of supporting global clinical and commercial manufacturing demand, including assessment of organization design, talent, workflows, development needs, and resource gaps.
• Establish manufacturing capacity plans, resource models, workforce plans, and operating strategies that support organizational growth and pipeline expansion.
• Ensure manufacturing operations comply with cGMP, applicable regulatory requirements, company quality systems, safety expectations, and industry best practices.
• Drive process performance, manufacturing robustness, and operational excellence to improve throughput, quality, cost, reliability, and scalability.
• Lead technology transfer from Process Development into GMP manufacturing and between internal operations and external manufacturing partners, as required.
• Direct MS&T activities supporting process monitoring, process characterization, validation, comparability assessments, investigations, continued process verification, and lifecycle management.
• Develop and implement manufacturing strategies for automation, digitalization, manufacturing execution systems, and data-driven process monitoring.
• Provide executive leadership for supply planning, procurement, inventory management, logistics, supplier relationship management, and supply continuity.
• Establish sourcing strategies and risk-mitigation plans for critical materials, consumables, raw materials, equipment, and service providers.
• Lead the selection, qualification, governance, and performance management of CDMOs and critical suppliers supporting manufacturing operations.
• Ensure effective Sales and Operations Planning (S&OP), demand forecasting, and supply planning to support clinical and commercial requirements.
• Partner with Quality to maintain inspection readiness and support regulatory inspections, internal audits, and supplier audits.
• Provide manufacturing leadership for regulatory filings, responses, and health-authority interactions, including INDs, BLAs, and global submissions.
• Partner with Facilities and Engineering to plan and execute manufacturing facility expansion, commissioning, qualification, and operational readiness.
• Develop and manage departmental budgets, capital plans, operating expenditures, and long-range manufacturing investment strategies.
• Establish key performance indicators and operational metrics to monitor manufacturing, supply chain, MS&T, supplier, quality, cost, and delivery performance.
• Communicate operational performance, material business risks, mitigation plans, and strategic recommendations to executive management and the Board of Directors, as appropriate.
• Foster a culture of safety, compliance, accountability, innovation, collaboration, employee development, and continuous improvement throughout the organization.
• Represent the company in regulatory meetings, industry conferences, partner engagements, and technical forums, as required.

EDUCATION AND EXPERIENCE:

• Bachelor's degree in engineering, life sciences, biotechnology, biochemical engineering, pharmaceutical sciences, or a related discipline required; advanced degree such as an MS, PhD, MBA, or equivalent preferred.
• Minimum 15 years of progressive experience in biopharmaceutical, cell therapy, gene therapy, regenerative medicine, or related manufacturing environments, including at least 8 years in senior leadership roles overseeing manufacturing or technical operations organizations.
• Demonstrated experience leading GMP manufacturing operations supporting clinical-stage and/or commercial biologics, cell therapy, or advanced therapy medicinal products.
• Significant experience developing, transferring, scaling, validating, and sustaining cell therapy manufacturing processes from clinical through commercial stages.
• Strong experience in MS&T, process validation, technology transfer, process characterization, comparability, and lifecycle process management.
• Experience leading complex supply chain operations, including supplier qualification, sourcing, materials management, forecasting, logistics, inventory control, and risk mitigation.
• Proven success selecting, governing, and managing CDMOs and strategic supply partners.
• Experience supporting regulatory inspections and interactions with the FDA, EMA, and other global health authorities.
• Demonstrated ability to lead large, multidisciplinary organizations and deliver complex strategic initiatives within approved budgets and timelines.
• Experience implementing manufacturing automation, manufacturing execution systems (MES), digital manufacturing solutions, and operational excellence programs highly desirable.
• Prior experience with autologous cell therapy manufacturing strongly preferred.

JOB SPECIFICATIONS:

• Executive and People Leadership: Ability to build, organize, develop, and lead high-performing teams and people leaders; set clear accountability; assess organization and workforce needs; and foster engagement, succession, and development.
• Manufacturing Strategy: Ability to align manufacturing capabilities, capacity, technology, supply, and investment priorities with product-development milestones, commercial readiness, and long-term corporate objectives.
• Technical Expertise: Comprehensive knowledge of cell therapy manufacturing, GMP operations, aseptic processing, technology transfer, process validation, process characterization, comparability, and lifecycle management.
• Operational Excellence: Strong knowledge of Lean manufacturing, continuous improvement, capacity planning, operating models, performance management, and scalable production systems.
• Supply Chain and External Partner Leadership: In-depth knowledge of sourcing, procurement, planning, inventory, logistics, supplier risk, CDMO governance, and strategic partner management.
• Regulatory and Quality Knowledge: Deep knowledge of FDA, EMA, ICH, cGMP, and global regulatory expectations applicable to cell and gene therapies, inspections, submissions, and commercial manufacturing readiness.
• Enterprise Judgment and Risk Management: Ability to evaluate ambiguous, cross-functional, and high-impact issues; balance quality, patient, compliance, supply, cost, schedule, and business risks; and recommend practical mitigation strategies.
• Financial Acumen: Ability to develop and manage departmental budgets, capital investments, operating expenditures, resource models, and long-range investment plans.
• Executive Communication and Influence: Ability to communicate complex technical and business matters clearly to executives, the Board, regulators, employees, external partners, and other stakeholders, and to build alignment on significant decisions.
• Data-Driven Decision Making: Ability to use KPIs, manufacturing data, trends, forecasts, and risk indicators to guide decisions and continuous improvement.
• Project and Portfolio Leadership: Ability to lead multiple complex, interdependent initiatives; establish priorities; allocate resources; and deliver results within quality, budget, and timeline expectations.
• Technical Proficiency: Proficiency with Microsoft Office and manufacturing-related enterprise systems, including ERP, MES, and quality management systems.

WORKING CONDITIONS

General office, manufacturing, laboratory, and cleanroom environment. This position requires occasional presence in GMP manufacturing areas and interaction with production operations. The employee may be exposed to standard laboratory materials and manufacturing equipment. Domestic and international travel may be required.

Some Cleanroom access is required

PHYSICAL DEMANDS

While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 10 pounds.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job.

EEO and Employment Eligibility:

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees. Aspen is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future.

Total Rewards and Culture:

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.

The anticipated salary range for candidates who will work in San Diego is $308,700-$377,300 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.