Vice President, Biologics Commercial Supply Chain Management Waltham, MA (Waltham)

Vice President, Biologics Commercial Supply Chain Management

Waltham, MA

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally,Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipelinecontinues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation !

Position Summary:

The Vice President of Biologics Commercial Supply Chain Management will provide strategy, direction, prioritization, and hands on subject matter expertise in biologics commercial supply chain management, while building and leading a high-performing team. S/he will work with internal and external teams to develop a biologics commercial supply chain strategy to meet the evolving needs of the business and will effectively deploy resources to execute the strategy. In accordance with Zenas’ outsourcing model for drug development and commercialization, the incumbent will oversee the planning, execution, and management of outsourced commercial supply chain activities and will work proactively with external partners to define project scope, mitigate risks, and ensure successful delivery as it relates to product quality, project timelines and budgets. S/he will work within a cross-functional commercial team environment to support Zenas’ short-term, intermediate, and long-term strategic goals.

Key Responsibilities:

• Establish the biologics commercial supply chain strategy and lead an integrated commercial supply chain to successfully launch Zenas’s first biologic combination product that requires cold chain logistics.
• Create and maintain commercial demand forecast and supply plan with a robust commercial inventory management system to facilitate on-time delivery and availability of commercial products.
• Partner with Commercial Teams, Technical Operations, Quality Assurance, Regulatory Affairs, Strategic Sourcing and Vendor Management, and external business partners to ensure seamless integration of supply chain strategies.
• Define standards and approach for business process management across the commercial supply chain and drive excellence in end-to-end operations through identification and management of commercial supply chain key performance indicators (KPIs). Drive operational efficiency and continuous improvement across the commercial supply chain to reduce COGs and deliver a best-in-class commercial supply chain. Establish CDMO risk mitigation strategies to ensure continuity of supply.
• Lead and manage shipping logistics of products and materials across the global commercial supply network and all aspects of the commercial labeling, packaging, kitting, serialization, and distribution activities at CDMOs.
• Play a key role in the Sales & Operations Planning (S&OP) process to align cross-functional teams and drive business plans to improve supply planning, increase service levels, optimize inventory levels, and achieve the company’s financial targets.
• Provide user requirements to the development and design of the ERP and serialization systems to comply with FDA Drug Supply Chain Security Act.
• Develop and manage budget/scope related to commercial supply chain.
• Maintain a high level of compliance with applicable quality standards, global regulatory requirements, and industry best practices.
• Pro-actively collaborate with internal stakeholders and external business partners to achieve group, departmental and corporate goals. Support business partner obligations.
• Develop and maintain SOPs, policies, and guidance documents relevant to areas of responsibility.
• Manage and execute personnel qualification/training program relevant to areas of responsibility.

Qualifications:

• BS/BA in science or engineering or a related field with a minimum of 20 years hands-on working experience in biologics commercial supply chain management in the biopharmaceutical industry is required. Advanced degree preferred.
• APICS certification is strongly favored.
• Must have hands-on working experience with ERP and serialization systems and setting up MRP systems.
• Must have experience in developing and managing commercial forecast, and commercial supply plan
• Must have experience working with CDMOs for commercial labeling, packaging, kitting, serialization, and distribution
• Proven track record of launching commercial products including building and scaling supply chain functions
• Demonstrated experience in presenting commercial supply chain systems, processes, and governance during inspections.
• Ability to cultivate a solution-oriented culturein which team members are developed and motivated to proactively identify solutions and to create an environment of continuous improvement
• Ability to recognize the importance of team effectiveness and hold team members accountable for operating collaboratively with others
• Ability to draw on deep industry network and experience in leading with confidence, driving innovation, and achieving operational excellence
• Ability to take responsibility for cultivating and enabling a culture of transparency by ensuring effective communication and collaboration within and across functions
• Experience in mentoring and coaching junior team members and conducts oneself in a way that encourages team members to ask for advice and help when needed
• Lead by example, giving team members a clear direction and model to follow and inspire employees to exceed expectations. Has a strong command for change management.
• Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
• Ability to work flexible business hours to communicate with global business partners (up to 20% of the time)

#LI-Hybrid

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $237,600 to $297,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.

Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.

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Equal Opportunity Employer

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, creed, sex, sexual orientation, pregnancy or pregnancy-related conditions, gender identity, genetic information, marital status, familial status, national origin, ancestry, ethnicity, protected veteran status, age, disability or any other factors prohibited by law.

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We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Zenas BioPharma.

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