Associate Director, Packaging Operations at Summit Therapeutics, Inc.

Princeton, NJ (US)Full-timeCMCPosted 2 months ago

About the Role

<div class="content-intro"> About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) <ul> <li> HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. </li> </ul> <ul> <li> HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. </li> </ul> <ul> <li> HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. </li> </ul> Colorectal Cancer (CRC) <ul> <li> HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. </li> </ul> Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. </div>Overview of Role:  The Associate Director of Packaging Operations will support development of the strategy and participate in the execution of Summit’s Packaging Operations for commercial product(s). This role is pivotal in ensuring the efficient and compliant delivery of high-quality pharmaceuticals to customers worldwide. The successful candidate will oversee the Operational delivery of commercial products in US and global markets, lead the tactical aspects of Summit’s engagement with external packaging operations partners, including managing vendor operational relationships.    Role and Responsibilities:  <ul> <li>Manage post launch related activities for US and global markets including delivery of Summit’s packaging production plan. </li> <li>Act as the main point of contact for managing manufacturing operational interactions with all commercial packaging vendors. </li> <li>Collaborate with internal launch teams to ensure all post launch related operational goals are met. </li> <li>Oversee ongoing packaging operations with the commercial packaging vendors to ensure on time delivery of finished goods at commercial distribution facility. </li> <li>Ensure cycle time from delivery of DP to the Packaging Vendor through to release of the packaged finished product are measured and meet required timelines. </li> <li>Track vendor performance against established KPIs, identify performance trends, and collaborate with vendors on corrective actions and continuous improvement opportunities. </li> <li>Support the implementation of the Technical Operations strategy to further manufacturing goals, including product availability, cost optimization, and customer satisfaction. </li> <li>Collaborate with CMC, Commercial, Finance, QA and operational teams, ensuring high levels of compliance, performance, and alignment with business objectives. </li> <li>Drive continuous improvement initiatives to enhance supply chain efficiency, sustainability, and resilience in the commercial packaging domain. </li> <li>Ensure the forecasted demand as presented by the Commercial SC team is aligned, managed and delivered, optimizing inventory levels and minimizing excess or shortages. </li> <li>Monitor packaging vendor execution against production schedules and communicate potential risks or delays to cross-functional stakeholders.  </li> <li>Participate in business review meetings with commercial packaging vendors to review operational performance, key metrics, and improvement initiatives.  </li> <li>Support supplier selection, onboarding, operational oversight, and performance management activities as needed.  </li> <li>Identify opportunities to improve packaging operations, reduce cycle times, and enhance operational efficiency while maintaining product quality and compliance. </li> <li>Proactively identify and resolve issues within the packaging operations chain that could affect the delivery of commercial products. </li> <li>Lead efforts to streamline processes, reduce lead times, and improve cost-efficiency without compromising product quality. </li> <li>Ensure that all packaging operations activities comply with relevant regulatory requirements, including cGMP (current Good Manufacturing Practices), GDP (Good Distribution Practices), and country-specific regulations. </li> <li>Stay current with industry trends and evolving regulatory standards to ensure compliance and alignment with best practices. </li> <li>All other duties as assigned.  </li> </ul>     Experience, Education and Specialized Knowledge and Skills:  <ul> <li>Qualification: Bachelor’s degree in Supply chain management, Engineering, Operations, or a life sciences industry related field. </li> <li>MBA or advanced degree in Supply Chain, Logistics, or a related field is preferred. </li> <li>Minimum of 7+ years of experience in global supply chain management and manufacturing operations in the pharmaceutical/ biotech area. </li> <li>Extensive experience in managing packaging operations, including expedited launches, demand forecasting, inventory management, manufacturing operations and distribution logistics. </li> <li>Proven experience working with third-party manufacturers (CMOs) and logistics providers, ensuring quality standards and on-time delivery. </li> <li>Strong understanding of regulatory and compliance standards in the biotech industry (e.g., cGMP, GDP, and other global regulations). </li> <li>Experience in managing global teams and driving cross-functional collaboration. </li> <li>Excellent analytical and problem-solving skills with the ability to make data-driven decisions. </li> <li>Expertise in supply chain management software (ERP, SAP, etc.) and advanced Excel skills. </li> <li>Strong communication skills, both verbal and written, with the ability to convey complex ideas clearly and effectively. </li> <li>Ability to thrive in a fast-paced, dynamic environment, managing multiple priorities simultaneously. </li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="description">This is the pay for this position</div><div class="title">Pay Transparency</div><div class="pay-range">$175,000—$200,000 USD</div></div></div><div class="content-conclusion">  Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at <a href="mailto:[email protected]" target="_blank">[email protected]</a> to obtain prior written authorization before referring any candidates to Summit. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.</div>

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