Associate Director, Formulation Development
<h3><strong>Who we are:</strong></h3>
<p>Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. </p>
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<h3><strong>How we work:</strong></h3>
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<li><strong>PIONEER</strong>: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.</li>
<li><strong>COLLABORATE</strong>: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.</li>
<li><strong>BELONG</strong>: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.</li>
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<h3><strong>How you’ll contribute:</strong></h3>
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<li>As a key member of the formulation development team, develop formulations to support pre-clinical and clinical development including oral and parenteral dosage form development and process optimization.</li>
<li>Oversee formulation/process development and manufacturing of clinical drug candidates with specific emphasis on mid to late state clinical development.</li>
<li>Design formulation studies and interpret data, oversee and coordinate CRO development and manufacturing activities.</li>
<li>Ensure physicochemical and material properties are incorporated as key aspect of rational formulation and process development.</li>
<li>Author technical reports, data summaries and CMC related documents required for regulatory submissions.</li>
<li>Manage related SOPs, change controls, deviations and CAPAs with thorough knowledge of Good Manufacturing Practices.</li>
<li>Represent the Pharmaceutical Development group in R&D teams, external interactions with CROs, and cross-functional teams.</li>
<li>Develop and maintain strong working relationships with key stakeholder groups in research and development to effectively support on-going programs.</li>
<li>Manage interactions with external CROs to ensure high quality and on-time execution.</li>
<li>Communicate program updates and status internally.</li>
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<h3><strong>Skills and experience you’ll bring:</strong></h3>
<ul>
<li>Advanced degree in pharmaceutical sciences, chemical engineering, or related scientific field with 7+ years of clinical stage <strong><span style="text-decoration: underline;">small molecule formulation development</span> </strong>experience.</li>
<li>Expert in small molecule formulation development with emphasis in oral solid and parenteral dosage forms.</li>
<li>Proficient in physicochemical and biopharmaceutical knowledge to assess drug candidate developability, pre-formulation, and formulation development.</li>
<li>Expertise in formulation process scale-up and optimization from lab to pilot scale.</li>
<li>Proven track record of applying scientific and engineering principles to formulation design, development, and process understanding.</li>
<li>Strong background in applying statistical approaches in the design and analysis of experiments.</li>
<li>Experience in applying a diversity of formulation and drug delivery technologies to improve the bioavailability of poorly soluble/permeable small molecule drug candidates.</li>
<li>Strong background in GMP manufacturing and experience with early and late stage drug product development and regulatory filings.</li>
<li>Experience in outsourcing and overseeing work done by CROs.</li>
<li>Experience with working in multidisciplinary teams.</li>
<li>Excellent communication skills and proficient in writing and reviewing technical reports.</li>
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<p><strong><em><span class="ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak">Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.</span></em></strong></p>
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