Associate Director, Formulation Development

<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><strong>Associate Director, Formulation Development</strong> </p> <p>As the Associate Director, Formulation Development reporting to the Sr. Director, Drug Product, you will lead pre-formulation, formulation development, tech transfer, scale-up, and manufacturing activities at Olema’s CMOs or CDMO partners. This role provides scientific expertise in solid oral dosage formulation development, early to late-stage process development, oversight of GMP drug product manufacture at contract development sites, authoring global regulatory filings (INDs, IMPDs, NDA, etc.) and technical oversight of packaging validation, shipping validation and transportation studies in preparation for commercial launch.  This position will collaborate with cross functional departments and other CMC functions in a fast-paced high growth environment to ensure progression of Olema’s small molecules from discovery through development/commercialization. </p> <p>This role is based out of our Dublin, Ireland office and will require <strong>25-30%</strong> <strong>travel</strong>.  </p> <p><strong>Your work will primarily encompass:</strong> </p> <ul> <li>Lead preclinical and early clinical phase formulation development effort at CMO and provide oversight of tech transfer to GMP vendor for clinical drug product manufacture and scale up </li> <li>Design and provide oversight of development and characterization studies in evaluating formulation development and drug product unit process feasibility </li> <li>Work closely with CMOs to address and refine formulation and process related challenges over the entire course of product development </li> <li>Develop strategies and execution plans for drug product development from first time in human through development of NDA ready formulations in accordance with timelines and requirements of program strategy </li> <li>Partner with clinical supply team to ensure uninterrupted drug product supply for ongoing studies and risk-mitigate strategically any supply constraints </li> <li>Work closely with project management for alignment on study timeline and corresponding drug product supply plan in terms of adequately securing GMP production slots at CDMOs </li> <li>Work closely with project management to identify critical CMC decision points, gain alignment at Program Team (PT) level and final endorsement from Executive Commitment (EC)  </li> <li>Work closely with regulatory CMC team (or consultants) to align on filing strategies from the perspective of being able to provide drug product for studies by clearing regulatory responsibilities  </li> <li>Engage in identifying high quality drug product manufacture CMOs or CDMOs in expertise, capability and capacity for effective collaboration in developing and/or commercializing Olema molecule </li> <li>Lead formulation and process development, technology transfer, clinical manufacturing activities & scale-up at CMOs or CDMOs </li> <li>Review and approve manufacturing documents, protocols and reports </li> <li>Support manufacturing and quality function in solving technical issues and addressing deviation investigations </li> <li>Support the design of experiments (DoE) studies to evaluate formulations and process parameter at CDMOs to support NDA filing </li> <li>Support the late-stage process development and optimization activities to identity CPPs, CQAs etc. leading to process performance qualification and commercialization  </li> <li>Write technical reports and author CMC sections of regulatory submissions related to drug product from IND through NDA stage of development </li> <li>Lead packaging validation, shipping validation & transportation studies at drug product CDMOs in preparation for Olema drug product commercialization </li> </ul> <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 <em>knowledge</em>, <em>experience</em>, and <em>attributes</em> for this role.</p> <p><strong>Knowledge & Experience</strong> </p> <ul> <li>Ph.D. / M.S in Pharmaceutical Science, Chemical Engineering or related field </li> <li>8+ years' experience in pre-formulation and formulation development for small molecules, preferably solid dosage forms, 5+ years in managing outsourced development activities </li> <li>Experience in formulation and process development; preferably with direct experience with late-stage oral solid dose manufacturing process </li> <li>Good working knowledge of GMP requirements for drug product development and manufacturing </li> <li>Good understanding of ICH, FDA, EMA guidance's in CMC and Quality areas </li> <li>Effective written, oral communication and interpersonal skills </li> <li>Experience in leading formulation projects in pre-formulation, formulation development, process selection and scale up, and oversight of GMP manufacture </li> <li>Experience in leading packaging validation, shipping validation and& transportation studies  </li> <li>Be self-motivated, organized, detail-oriented, team-oriented, & problem-solving oriented </li> <li>Being proactive, strategic and skillful in multi-tasking </li> <li>Excel in team settings with ability to think critically, outside of box for problem-solving and work independently </li> </ul> <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>