Director, CMC Drug Substance Manufacturing at Olema Oncology

<div class="content-intro"><p>Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.&nbsp;&nbsp;</p> <p>Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for <strong>our patients, for your career, for what’s beyond</strong>.&nbsp;</p> <p>You can view our latest corporate deck and other presentations <a href="https://ir.olema.com/" target="_blank">here</a>.</p></div><p>About the Role &gt;&gt;&gt; Director, CMC Drug Substance Manufacturing</p> <p>As the Director, CMC Drug Substance Manufacturing reporting to the Sr Director, Drug Substance Development and Manufacturing, you will provide technical leadership and hands-on execution to support late-stage development, technology transfer to CDMOs, and commercial readiness including NDA filing for small molecule drug substances. This role is critical to ensuring successful scale-up, validation, and regulatory approval of drug substance processes. The individual will work cross-functionally and externally with CDMOs to deliver robust, compliant, and efficient manufacturing processes suitable for commercial supply.</p> <p>This role is based out of our Dublin, Ireland office and will require 10-15% travel.</p> <p>Your work will&nbsp;<em>primarily</em>&nbsp;encompass:&nbsp;</p> <ul> <li>Lead technology transfer of drug substance processes (RSM/API) to CDMOs, including strategy, execution, and risk management to support late-stage development and commercial manufacturing&nbsp;</li> <li>Provide technical oversight of CDMO activities, including process validation, manufacturing campaigns, and on-site support; serve as the primary technical point of contact&nbsp;</li> <li>Review and approve key manufacturing and development documentation (batch records, protocols, reports, specifications, and deviations) to ensure compliance and data integrity&nbsp;</li> <li>Lead deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs) to support reliable manufacturing performance&nbsp;</li> <li>Drive process robustness, control strategy development (e.g., DOE, PAR), and PPQ readiness to enable successful validation and commercial supply&nbsp;</li> <li>Leverage process and manufacturing data to enhance process understanding,&nbsp;monitor&nbsp;performance across sites, and&nbsp;identify&nbsp;opportunities for continuous improvement&nbsp;</li> <li>Support commercial supply readiness, including supply continuity, cost of goods optimization, and lifecycle management activities&nbsp;</li> <li>Author and review CMC sections of IND/NDA submissions, and support regulatory interactions, responses, and inspection readiness&nbsp;</li> <li>Identify&nbsp;technical risks and proactively develop mitigation strategies to ensure timelines for NDA filing and commercial launch are achieved&nbsp;</li> <li>Partner cross-functionally with Quality, Regulatory, Analytical, Drug Product, and Supply Chain to ensure aligned execution and compliance with global regulatory requirements&nbsp;</li> </ul> <p><strong>Ideal Candidate Profile &gt;&gt;&gt;&nbsp;&nbsp;</strong></p> <p><strong>A love of challenging, important work.&nbsp;</strong>We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All&nbsp;employees&nbsp;within our company play a&nbsp;unique and&nbsp;crucial role&nbsp;in our success, both in&nbsp;accomplishing&nbsp;our mission and building&nbsp;a positive&nbsp;company culture. As such, we are looking for&nbsp;someone with&nbsp;the right combination of&nbsp;<em>knowledge</em>,&nbsp;<em>experience</em>, and&nbsp;<em>attributes</em>&nbsp;for this role.&nbsp;</p> <p><em>Knowledge&nbsp;and experience:</em>&nbsp;</p> <ul> <li>Ph.D. in Organic Chemistry or related discipline with ~10+ years of experience (or M.S. with ~15+ years) in small molecule CMC drug substance development and manufacturing&nbsp;</li> <li>Demonstrated experience leading technology transfer, scale-up, and validation of API processes to GMP manufacturing sites for late-stage and commercial programs&nbsp;</li> <li>Strong experience managing CDMOs, including vendor selection, technical oversight, and delivery of manufacturing campaigns aligned with quality, timeline, and cost objectives&nbsp;</li> <li>Proven success authoring and reviewing CMC sections of INDs, IMPDs, and NDAs/MAAs, and supporting regulatory interactions and responses with health authorities&nbsp;</li> <li>Strong technical foundation in small molecule process development, manufacturing, and control strategy, including DOE, PAR, and impurity control (e.g., fate and purge)&nbsp;</li> <li>Deep understanding of cGMP requirements and global regulatory expectations (ICH guidelines), with experience supporting inspection readiness and compliant manufacturing execution&nbsp;</li> <li>Demonstrated ability to&nbsp;identify&nbsp;technical risks and apply risk-based decision-making to drive&nbsp;timely&nbsp;and practical solutions&nbsp;</li> <li>Experience integrating process and manufacturing data to support process understanding, trend analysis, and continuous improvement&nbsp;</li> <li>Strong project management and communication skills, with the ability to influence cross-functional teams and external partners in a matrixed environment&nbsp;</li> </ul> <p><em>Attributes:</em>&nbsp;</p> <ul> <li>Curious, scientifically rigorous, and proactive with a strong “can-do” mindset&nbsp;</li> <li>Self-motivated and accountable, able to work independently and drive results&nbsp;</li> <li>Effective collaborator across cross-functional teams and external partners&nbsp;</li> <li>Highly analytical and detail-oriented, with a data-driven approach&nbsp;</li> <li>Organized and execution-focused, able to manage multiple priorities and timelines&nbsp;</li> <li>Committed to high scientific, quality, and ethical standards while driving continuous improvement&nbsp;</li> </ul> <p style="visibility: hidden;">#LI-MK1</p><div class="content-conclusion"><p><strong>Important Information </strong><strong>&gt;&gt;&gt;</strong><strong> </strong></p> <p>We provide <strong>equal opportunity to all employees and applicants for employment</strong> and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.</p> <p>We offer a <strong>competitive compensation and benefits package</strong>, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.</p> <p><em>Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.</em></p> <p><em><span style="text-decoration: underline;"><strong>Fraud Alert</strong></span>: &nbsp;</em><span data-olk-copy-source="MessageBody">We are aware of employment scams where individuals pose as representatives of Olema Oncology&nbsp;and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is&nbsp;</span><a class="x_Hyperlink x_SCXW164988465 x_BCX0" href="https://olema.com/" target="_blank" data-outlook-id="a6e0c82d-5429-4e8c-b591-752f2a6a6de4" data-auth="NotApplicable" data-linkindex="0">olema.com</a>; our careers page is&nbsp;<a class="x_Hyperlink x_SCXW164988465 x_BCX0" href="https://olema.com/careers/" target="_blank" data-outlook-id="d0a0a54e-53bc-4d3b-adf5-ae9c7e616cf0" data-auth="NotApplicable" data-linkindex="1">olema.com/careers</a>; our LinkedIn page is&nbsp;<a class="x_Hyperlink x_SCXW164988465 x_BCX0" href="https://www.linkedin.com/company/olema-oncology/" target="_blank" data-outlook-id="3d87665c-af14-40dc-bd98-9c9a4d15c43a" data-auth="NotApplicable" data-linkindex="2">linkedin.com/company/olema-oncology</a>.&nbsp;Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments&nbsp;of any kind, and does not make job offers without an in-person interview.</p></div>