Senior Director, Commercial Manufacturing & Operations

<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.  </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>. </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 >>> Sr Director, Commercial Manufacturing & Operations</p> <p>As the Sr Director, Commercial Manufacturing & Operations reporting to the SVP of CMC & Supply Chain, you will be an experienced manager with a track record of successful project leadership and oversight of late-stage (registrational, process validation, commercial) manufacturing of small molecule drug substances and drug products. You will be responsible for the execution of technical transfer (including process validation activities), oversight of manufacturing activities, document review, quality event support, etc. for drug substances and drug product.</p> <p>This role is based out of our Boston, USA and/or Dublin, IRL office and will require 20% travel.</p> <p>Your work will primarily encompass:</p> <p>· Support the US launch of palazestrant in 2027 by creating the commercial supply platform and strategy</p> <p>· Establish an operational commercial mapping of supply and partners (state licenses, 3PL & order-to-cash Services, shipping and import/export logistics, import/export compliance)</p> <p>· Provide technical and functional project leadership on drug substance (DS) and drug product (DP) commercial manufacturing, and CMO management</p> <p>· Develop business processes and systems to support and streamline all DS and DP commercial activities. Work globally to implement processes and systems within Olema’s global CDMO network. Develop metrics and continuous improvement initiatives.</p> <p>· Provide site leadership with awareness of employee needs at all levels of the site, ensuring employees are engaged and tied to the global Olema’s business strategy</p> <p>· Lead or manage documentation review and approval (MBRs, specifications, analytical methods, etc.), change controls and documentation for internal batch disposition</p> <p>· Oversee investigations related to deviations to assess impact to product and manufacturing process; ensures timely closure of such investigations</p> <p>· Partner with Commercial, Quality Assurance and CMC Regulatory Affairs SMEs to develop and operate appropriate commercial procedures to ensure the drug substance and drug product meets established quality standards and adheres to established and regulatory agency approved parameters</p> <p>· Work closely with SMEs and CMOs to execute shipment of drug substance batches and drug product lots</p> <p>· Partner with supply chain teams to design DS and DP production schedules while maximizing production and cost efficiencies</p> <p>· Develop, maintain and communicate product manufacturing plans, timelines, milestones and budgets. Integrate and align commercial manufacturing activities with corporate development program objectives. Develop and apply resource and capacity models</p> <p>· Stay current with state-of-the art approaches and applicable global regulations and industry standards</p> <p>Ideal Candidate Profile >>></p> <p>A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.</p> <p>Knowledge and experience:</p> <p>· BS/MS/Ph.D. in Chemistry, or related discipline with a minimum of 10+ years of experience, or a business degree with a minimum of 15 years of experience, in a CMC development and manufacturing organization</p> <p>· Sense of urgency, ability to recognize time sensitivity, appetite to lead aggressive activity within the manufacturing function</p> <p>· Flexible and adaptable style, achievement oriented by nature with a willingness and eagerness to take on challenges</p> <p>· Visionary as well as tactile and concrete at an operational level.</p> <p>· Demonstrated successful leadership in a pharmaceutical CMC drug substance and drug product development and manufacturing role</p> <p>· Broad experience working with CDMOs and managing external development and manufacturing partners</p> <p>· Expertise in oversight of GMP manufacturing, including tech transfer and process validation</p> <p>· Understanding of supplier performance management (quality metrics, adherence to supply and quality agreements) and familiarity with commercial supply agreement negotiations</p> <p>· Thorough understanding of global regulatory requirements for the manufacture, testing, and control of commercial drug substances</p> <p>· Strong communication, negotiation, problem solving and decision-making skills at all levels of the organization, verbally and in writing</p> <p>· Ability to work collaboratively to connect vision, strategy and goals and present plans, justifications and mitigation scenarios to executive management</p> <p>· Effective written, oral communication and interpersonal skills</p> <p>Attributes:</p> <p>· A high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally. Strong initiative and follow-through are essential for this job.</p> <p>· Specific personal characteristics include:</p> <p>o Highly analytical and detail oriented</p> <p>o Self-Starter</p> <p>o Goal and data driven</p> <p>o Ability to multi-task and shift priorities rapidly to meet tight deadlines</p> <p>o Aspires to the highest scientific and ethical standards</p> <p>o Keen to improve processes and overcome inefficiencies</p> <p> </p> <p>#LI-MK1</p> <p style="visibility: hidden;">#LI-MK1</p><div class="content-conclusion"><p><strong>Important Information </strong><strong>>>></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>:  </em><span data-olk-copy-source="MessageBody">We are aware of employment scams where individuals pose as representatives of Olema Oncology 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 </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 <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 <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>. 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 of any kind, and does not make job offers without an in-person interview.</p></div>