Senior Director, Manufacturing Sciences & Technology

Asahi Kasei•Cary, NC

1d•$205 - $230•Onsite

About The Position

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility. Company: Veloxis Pharmaceuticals, Inc. Job Description: The Senior Director, Manufacturing Sciences and Technology (MS&T) serves as the technical leader for all commercial activities supporting EnvarsusTM. This includes end-to-end responsibility for technical oversight of commercial manufacturing, process performance, lifecycle management, and ongoing technical operations across all external suppliers, including API manufacturers, drug product sites, and testing laboratories. The incumbent leads the cross-functional team that supports commercial production at suppliers, including Quality, Supply Chain, Analytical, Manufacturing, and Technical Operations contributors. This is a matrix leadership role and involves communicating product needs, internally, coordinating internal and external activities and ensuring proper execution and monitoring via performance metrics. The role serves as a key Pharmaceutical Operations & Technology (PO&T) interface with the Company’s commercial partners in Europe and Canada, ensuring proper regulatory review and alignment for all filing impacting activities. These activities are in coordination with the Company’s Program Alliance Management team (PAM). The scope includes deviations and investigations, change controls, validation strategies, regulatory submissions, annual reports, and supply and lifecycle initiatives that impact commercial product supply. The position also leads PO&T’s Continuous Process Verification (CPV) program, with accountability for CPV strategy, execution, and data review for EnvarsusTM, as well as oversight of CPV implementation for all commercial products in the Company’s portfolio. Additionally, the role oversees the development and expansion of the Company’s process analytics capability, enabling data-driven technical decision-making in support of both commercial and clinical programs. This position plays a central role in the ongoing governance of strategic manufacturing partners. As appropriate, this role is responsible for coordinating business review meetings (BRM) with suppliers, communicating performance insights, driving process robustness, and advancing lifecycle strategies that ensure compliant and reliable commercial manufacturing. The role is in office, with expectations for being in the Cary office 4 days per week. This incumbent is also responsible for forecasting, maintaining and approving all Manufacturing and Technical Operations (MTO) budget items for EnvarsusTM,, CPV and Process Analytics, as well as creating detailed forecasts for each line item, obtaining spend approval in the Company’s system, updating Scopes of Work (SOW), change orders (CO) and Purchase Orders (PO) and obtaining approval in the Company’s system. The responsibilities also include reviewing and reconciling all invoices against plan and budget. The base compensation range for this role is $205 - 230K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

Requirements

Bachelor’s degree in relevant STEM discipline. Advanced degree (MSc, PhD, or MBA) strongly preferred.
Extensive experience in commercial manufacturing sciences & technology, technical operations, or process engineering in the biopharmaceutical industry.
Deep expertise supporting commercial products at external manufacturing sites (API and drug product).
Proven success leading teams in a matrixed technical environment.
Demonstrated capability in deviations, investigations, change control, validation, and lifecycle management.
Experience interfacing with global regulatory bodies and commercial partners.
Practical experience with CPV program ownership or comparable process monitoring systems.
Strong technical foundation in pharmaceutical manufacturing and process performance.
Excellent leadership, communication, and cross-functional coordination skills.
Ability to build trusted relationships with suppliers, internal teams, and commercial partners.
Strong analytical mindset with the ability to interpret and act on complex data sets.
Ability to travel internationally and work across cultures and time zones.
Fluent in English; additional languages beneficial.
Approximately five (5) international trips per year to European suppliers and partners.
Occasional travel to India to support API manufacturing.

Nice To Haves

Background in data analytics, process modeling, or process performance trending preferred.

Responsibilities

Commercial Manufacturing Technical Leadership Provides end-to-end technical oversight of commercial manufacturing processes for EnvarsusTM and life cycle management.
Lead all technical activities at external suppliers, including API, and Drug Product mfg sites and lead the PO&T matrix team that oversees manufacturing at packaging sites.
Serve as the primary technical authority for EnvarsusTM process, supplier performance, deviations, investigations, change controls, validation, and lifecycle management.
Ensure manufacturing processes remain compliant, robust, and capable as product matures.
Develop technical strategies to support process optimization and long-term reliability across the manufacturing network.
Cross-Functional Leadership Across Supplier Activities Matrix leadership and coordination of the Company functional team supporting supplier operations, including Quality, Analytical, Supply Chain, Process Development and Technical Operations contributors.
Ensure clear alignment of roles, deliverables, and expectations across internal team members.
Oversee the technical execution of planned campaigns, validations, and lifecycle work and ensure internal team alignment on all key PO&T EnvarsusTM objectives.
Support Supply Chain by adapting manufacturing to achieve supply objectives, capacity and trends and escalating risks proactively.
Regulatory Alignment and Commercial Partner Interface As a member of the PAM team and act as the primary PO&T interface with commercial partners in Europe and Canada on all process-related topics.
Ensure appropriate regional review and approval of deviations, investigations, change controls, and validation strategies.
Support preparation and review of regulatory submissions, including CMC sections, variations, supplements, and annual reports.
Coordinate technical communication to ensure full transparency and alignment with partner regulatory expectations.
Continuous Process Verification (CPV) Ownership Leads the CPV program for EnvarsusTM, including CPV strategy, annual reviews, data trending, and regulatory compliance.
Oversee implementation of CPV for all additional commercial products acquired or launched by the Company.
Drive ongoing process understanding using data analytics, risk assessments, and statistical process control methodologies.
Ensure CPV program supports the Company’s Annual Product Review and our process, the suppliers and their facilities all remain in a state of validation.
Process Analytics Capability Leadership Build and oversee a dedicated process analytics group responsible for advanced data analytics supporting commercial and clinical programs.
Implement tools, systems, and analytical approaches that enhance process monitoring, prediction, and control.
Ensure analytical outputs are aligned with commercial, clinical, and regulatory needs.
Supplier Governance and Performance Management (as appropriate) Coordinate BRM with key suppliers, including agenda development, performance reporting, and long-term strategic planning.
As necessary, include partners in these BRM and ad hoc meetings Establish and steward KPIs that measure process reliability, compliance, and execution quality across the network.
Drive continuous improvement initiatives at suppliers, including yield optimization, robustness improvements, and cost-reduction opportunities.
Lead or support technical due diligence and onboarding of new suppliers.
Risk Management & Compliance Identify and mitigate technical, compliance, and supply risks across the manufacturing network.
Partners with the PO&T team, ensure readiness for audits, inspections, and partner reviews.
Responsible for all MTO related audit items.
During a Company audit, this role is expected to be auditor facing and to represent all EnvarsusTM MTO items.
Maintain clear, data-driven visibility to process performance and escalation pathways.