Senior Principal Engineer/Associate Director, Drug Product MSAT

<div class="content-intro"><p></p> <p><strong>About Summit:</strong></p> <p>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.</p> <p>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:</p> <p><strong>Non-small Cell Lung Cancer (NSCLC)</strong></p> <ul> <li> <p>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.</p> </li> </ul> <ul> <li> <p>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.</p> </li> </ul> <ul> <li> <p>HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.</p> </li> </ul> <p><strong>Colorectal Cancer (CRC)</strong></p> <ul> <li> <p>HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.</p> </li> </ul> <p><em>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.</em></p> <p></p></div><p><strong>Overview of Role:</strong></p> <p>We are seeking a highly experienced and strategic Senior Principal Engineer/Associate Director of MSAT - Drug Product to join the CMC team and be a key contributor to ongoing process development, technology transfer, process validation, BLA/MAA/IND/IMPD authoring and readiness, and agency interaction activities, in preparation for commercialization and incremental clinical/commercial batch production of our main asset. This role will focus on leading DP Tech transfer(s), authoring technical reports and on providing content to the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met. The ideal candidate will bring significant experience in biologics manufacturing, sterile drug product operations, and regulatory expectations.&nbsp;&nbsp;</p> <p>&nbsp;</p> <p><strong>Role and Responsibilities:</strong></p> <ul> <li>Provide technical&nbsp;expertise&nbsp;for&nbsp;phase-appropriate&nbsp;drug product&nbsp;process development, characterization,&nbsp;validation, and technology transfer for&nbsp;sterile&nbsp;drug&nbsp;product&nbsp;(DP).&nbsp;</li> <li>Assess and manage process risks arising from manufacturing or process changes.&nbsp;</li> <li>Serve as a primary&nbsp;or supporting&nbsp;technical interface with external CDMOs and internal manufacturing teams.&nbsp;&nbsp;</li> <li>Lead or significantly contribute to implementation of process, product, and site changes across the product lifecycle.&nbsp;&nbsp;</li> <li>Support and guide execution of clinical and commercial batch manufacturing activities to meet development and supply timelines.&nbsp;&nbsp;</li> <li>Assist&nbsp;in the authorship,&nbsp;data verification,&nbsp;update, and/or review of regulatory filings.&nbsp;</li> <li>Provide technical feedback during regulatory agency inquiries.&nbsp;&nbsp;</li> <li>Lead PPQ execution and manufacturing oversight in alignment with GMP and quality system requirements through person in plant.&nbsp;&nbsp;</li> <li>Collaborate closely with Regulatory, Quality, Supply Chain, and other CMC functions to ensure integrated planning and execution.&nbsp;&nbsp;</li> <li>Ensure GMP compliance across all assigned activities.&nbsp;&nbsp;</li> <li>Support audits, inspections, and continuous improvement initiatives.&nbsp;&nbsp;</li> <li>Manage process deviation investigations and change controls.&nbsp;</li> <li>Travel&nbsp;as&nbsp;needed to support technology transfer, process scale-up, and collaboration with external partners.&nbsp;</li> <li>All other duties as assigned</li> </ul> <p><br><strong>Experience, Education and Specialized Knowledge and Skills:</strong></p> <ul> <li>Bachelor’s&nbsp;degree&nbsp;in chemical engineering, biotechnology, pharmaceutical science, or&nbsp;a related&nbsp;field&nbsp;required.&nbsp;Advanced degree (Masters&nbsp;or PhD) preferred.&nbsp;</li> <li>Minimum of&nbsp;10+ years of relevant experience&nbsp;within the life sciences industry&nbsp;&nbsp;</li> <li>Demonstrated experience in process development, MSAT (Manufacturing Science and Technology), and/or manufacturing&nbsp;with a focus on sterile drug&nbsp;product&nbsp;and late-phase development&nbsp;(preferably&nbsp;mAbs) is essential.&nbsp;&nbsp;</li> <li>Experience with technology transfer across different systems, scales, and sites is highly valued&nbsp;</li> <li>Experience in late-stage process development, characterization and validation is highly valued&nbsp;</li> <li>IND/IMPD and BLA/MAA Module 3 authorship experience and Continuous Process Verification planning and execution highly preferred&nbsp;</li> <li>Data Analytics experience including JMP and other data organization (AI-based or not)&nbsp;platforms a strong plus&nbsp;</li> <li>Strong communication, management, and interpersonal skills to effectively influence across the organization and with CDMOs/CMOs.&nbsp;</li> <li>Excellent attention to detail and organizational skills, with a focus on quality and technical excellence.&nbsp;</li> <li>Good information&nbsp;management and data organization skills&nbsp;</li> <li>Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.&nbsp;</li> <li>A track record&nbsp;of working under pressure and delivering high-quality results to tight deadlines.&nbsp;</li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>This is the pay for this position</p></div><div class="title">Pay Transparency</div><div class="pay-range"><span>$180,000</span><span class="divider">&mdash;</span><span>$195,000 USD</span></div></div></div><div class="content-conclusion"><p>&nbsp;</p> <p>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.</p> <p>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&nbsp;<a href="mailto:recruiting@smmttx.com" target="_blank">recruiting@smmttx.com</a>&nbsp;to obtain prior written authorization before referring any candidates to Summit.</p> <p><span data-teams="true">Summit Therapeutics Inc.&nbsp;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.</span></p></div>