Senior Scientist, Drug Product Development
SeniorSupply ChainOncologyADCs (Antibody-Drug Conjugates)
From $156K/yr(estimated)
Description
<div class="content-intro"><p><strong><u>Company Overview</u></strong></p>
<p><span data-olk-copy-source="MessageBody">Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets.</span></p></div><p><strong><u>Position Overview</u></strong></p>
<p>The Senior Scientist, Drug Product Development will lead formulation and drug product (DP) development for our ADC pipeline. This individual will play a key role in establishing internal lab capabilities, executing formulation studies, developing lyophilization cycles, and partnering cross-functionally within CMC and Clinical teams. The ideal candidate will thrive in a fast-paced, startup environment and be comfortable balancing strategic planning with hands-on laboratory execution.</p>
<p><strong><u>Responsibilities</u></strong></p>
<ul>
<li>Lead formulation development for antibody and ADC drug products, including stability-indicating formulation screening and optimization for early and late stage products.</li>
<li>Design, develop (internally and/or externally), and tech-transfer drug product processes including lyophilization, for ADC drug products to ensure manufacturability, and scalability.</li>
<li>Support building internal formulation lab capabilities, including equipment selection.</li>
<li>Serve as the internal subject matter expert (SME) for DP formulation and lyophilization, guiding both internal scientists, as the team expands, and external CDMOs.</li>
<li>Collaborate closely with ADC DS Development, Analytical Development, QC and QA teams to ensure end-to-end alignment across CMC.</li>
<li>Author and review CMC documentation, including development reports, regulatory submissions (IND/IMPD/BLA), and technical transfer packages.</li>
<li>Evaluate and implement emerging technologies for ADC formulation and lyophilization to drive innovation and efficiency.</li>
<li>Mentor and develop junior scientists as the team expands.</li>
</ul>
<p><strong><u>Qualifications</u></strong></p>
<ul>
<li>A minimum of industry experience in biologics or ADC formulation and lyophilized drug product development.</li>
<li>Proven expertise in lyophilization cycle development, characterization, and scale-up for biologics.</li>
<li>Experience with ADCs and establishing internal lab is preferred.</li>
<li>Strong hands-on experience in formulation screening, stability studies, and analytical data interpretation.</li>
<li>Demonstrated experience establishing or operating in an internal lab environment.</li>
<li>Excellent understanding of CMC principles and regulatory expectations for biologic and ADC drug products associated to the products’ phase.</li>
</ul>
<p><strong><u>Knowledge and Skills</u></strong></p>
<ul>
<li>Deep understanding of formulation principles for biologics and ADCs, including critical quality attributes (CQAs), thermal stability and compatibility considerations.</li>
<li>Proficiency in fill/finish and lyophilization process development, scale-up, optimization, tech-transfer and troubleshooting.</li>
<li>Strong analytical skills for interpreting data from formulation and stability studies.</li>
<li>Working knowledge of regulatory requirements for clinical and commercialization of sterile drug products, including application of Quality by Design principles</li>
<li>Excellent communication and collaboration skills to work cross-functionally and with external partners.</li>
<li>Ability to innovate and implement emerging technologies in drug product development.</li>
<li>Ability to manage multiple projects with tight deadlines and priorities.</li>
<li>Leadership skills to mentor junior scientists and/or manage projects effectively.</li>
</ul><div class="content-pay-transparency"><div class="pay-input"><div class="title">Washington State Pay Range</div><div class="pay-range"><span>$155,896</span><span class="divider">&mdash;</span><span>$192,334 USD</span></div></div></div><div class="content-conclusion"><p><strong><u>E/E/O</u></strong></p>
<p>Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.</p>
<p><strong><u>E-Verify</u></strong></p>
<p>Immunome, Inc. is a participant in E-Verify. Please review the following notices: <a href="https://immunome.box.com/s/bopxukipfidxjscs4bjxt75f90bvpppk" target="_blank">E-Verify Participation Poster</a> | <a href="https://immunome.box.com/s/r51g9subw1wqni9xkutbl6up635sjr8e" target="_blank">Right to Work Poster (English)</a> | <a href="https://immunome.box.com/s/r3ekbimwh988my9vzl76tnlbg60zvh9u" target="_blank">Right to Work Poster (Spanish)</a>.</p></div>