Principal Engineer, Pharma CMC Manufacturing & Tech Transfer

<div class="content-intro"><h2><span data-contrast="none">About Varda</span></h2> <p>Low Earth orbit is open for business. Varda is accelerating the development of commercial space infrastructure, from in-orbit pharmaceutical processing to reliable and economical reentry capsules. <strong>Varda’s W-Series vehicles are built, designed, and operated by Varda in-house, including the pharmaceutical processing payloads, the capsules, the C-PICA heat shields, and the satellite buses.</strong></p> <p>From life-saving pharmaceuticals to more powerful fiber optics, there is a world of products used on Earth today that can only be manufactured in space. Varda is accelerating innovation in the orbital economy by creating both the products and infrastructure needed so space can directly benefit life on Earth. Our mission is to expand the economic bounds of humankind.  </p> <p>Our team is uniquely suited to accomplishing this goal, with leadership and staff comprised of veterans from SpaceX, Blue Origin, major pharmaceutical companies and Silicon Valley. Varda was founded in January 2021 by Will Bruey and Delian Asparouhov with significant backing from world class investors including Khosla Ventures, Lux Capital, Founders Fund, Caffeinated Capital, General Catalyst, and Also Capital.  </p> <p>Varda is headquartered in El Segundo, California, where we have offices and a production facility where our vehicles, equipment, and materials are built, integrated, and tested. Varda also has offices in Washington, DC and Huntsville, AL. </p> <p>Join Varda, and work to create a bustling in-space ecosystem.</p></div><h2><span data-contrast="none">About This Role</span></h2> <p><span data-contrast="auto">Our CMC team is looking for a highly motivated and experienced Principal Engineer, Pharma CMC Manufacturing & Tech Transfer to lead process transfer, CDMO qualification, pilot scale manufacturing, and GMP manufacturing oversight for Varda's crystallization and drug product pipeline. Reporting to the VP, CMC, this role owns the path from a lab-characterized process to a validated, transferable manufacturing package executed reliably across a network of external partners. This position requires close collaboration with Pharma R&D, Quality & Regulatory, and external CDMO partners to stand up and run the manufacturing network.</span><span data-ccp-props="{"335559739":120}"> </span></p> <p><span data-contrast="auto">This is an opportunity to build a CMC manufacturing function from the ground up — selecting and qualifying CDMO partners, executing technology transfer, running engineering & pilot scale batches, and ultimately delivering GMP clinical material — while helping shape how Varda's terrestrial and orbital manufacturing strategies come together.</span><span data-ccp-props="{"335559739":120}"> </span></p> <p><strong><span data-contrast="none"><span data-ccp-parastyle="heading 2">Responsibilities</span></span></strong><span data-ccp-props="{"335559738":280,"335559739":120,"335572079":6,"335572080":4,"335572081":6567967,"469789806":"single"}"> </span></p> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Own technology transfer execution: translate R&D developed processes into robust, CDMO-ready transfer packages</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Lead pilot plant production of material to support nonclinical development</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Lead selection, qualification, and ongoing management of CDMO partners across the manufacturing network (Crystallization, Fill-Finish, and DS Partner), including RFPs, technical due diligence, and capability assessments</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Lead tech transfer of drug product fill-finish processes for the crystalline suspension, partnering with R&D on process- and product-specific technology transfer coordination</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Negotiate and manage Manufacturing Services Agreements with CDMO partners, defining scope, key terms, and deliverables, in partnership with Legal and Quality</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Establish the CDMO oversight model, including defined chain of custody across CDMO handoffs</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Lead engineering run execution and acceptance at CDMO sites, including comparability protocols confirming CDMO-produced material matches Varda-characterized material</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">As volumes increase, build and lead an internal Manufacturing Sciences & Technology (MS&T) function to support process transfer, engineering runs, and GMP manufacturing oversight</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto">Oversee GMP manufacturing campaigns through batch release, partnering with Quality on batch record review, change control, deviation management, and release testing coordination</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto">Manage CDMO manufacturing timelines and budget; report progress regularly to the VP, CMC and executive team</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="Calibri" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="auto">Partner with Quality & Regulatory on control strategy, release specifications, and CMC sections of regulatory filings related to manufacturing and tech transfer</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <p><strong><span data-contrast="none"><span data-ccp-parastyle="heading 2">Basic Qualifications</span></span></strong><span data-ccp-props="{"335559738":280,"335559739":120,"335572079":6,"335572080":4,"335572081":6567967,"469789806":"single"}"> </span></p> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="auto">10+ years of CMC manufacturing and/or technology transfer leadership experience advancing drug product development programs to successful clinical trials</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="auto">B.S. or M.S. in life sciences, chemical engineering, or related field</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="14" data-aria-level="1"><span data-contrast="auto">Firm understanding of cGMP and FDA regulatory guidelines as they pertain to CMC manufacturing and tech transfer</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="15" data-aria-level="1"><span data-contrast="auto">Demonstrated experience managing external CDMO/CMO relationships, including technical oversight and contract negotiation</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <p><strong><span data-contrast="none"><span data-ccp-parastyle="heading 2">Preferred Skills and Experience</span></span></strong><span data-ccp-props="{"335559738":280,"335559739":120,"335572079":6,"335572080":4,"335572081":6567967,"469789806":"single"}"> </span></p> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="16" data-aria-level="1"><span data-contrast="auto">13+ years of CMC manufacturing leadership experience, including direct responsibility for process transfer and CDMO network management</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="17" data-aria-level="1"><span data-contrast="auto">Experience with small molecule and/or biologics crystallization processes and/or high-concentration suspension drug products</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="18" data-aria-level="1"><span data-contrast="auto">Hands-on experience standing up a CDMO network from selection through GMP manufacturing for an early-stage or growth-stage biotech/pharma company</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="19" data-aria-level="1"><span data-contrast="auto">Experience with aseptic fill-finish operations and engineering/media fill run execution</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="20" data-aria-level="1"><span data-contrast="auto">Advanced understanding of cGMP and FDA regulations and guidance relating to CMC manufacturing and comparability</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="21" data-aria-level="1"><span data-contrast="auto">Excellent leadership, managerial, and communication skills in a cross-functional, multi-site environment</span><span data-ccp-props="{"335559739":60}"> </span></li> </ul> <ul> <li data-leveltext="•" data-font="" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":504,"335559991":288,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="22" data-aria-level="1"><span data-contrast="auto">Experience in an aerospace regulatory environment (e.g., AS9100) is a plus<br></span><br> <h2>Pay Range</h2> <ul> <li>Salary range: $187,000 - $239,000/per year</li> <li>This role is on-site<strong> </strong>in El Segundo, CA</li> <li>Leveling and base salary is determined by job-related skills, education level, experience level, and job performance</li> <li>You will be eligible for long-term incentives in the form of stock options and/or long-term cash awards</li> </ul> <br><br></li> </ul><div class="content-conclusion"><h2>ITAR Requirements</h2> <p>Varda, like all employers, must ensure that its employees working in the United States are lawfully authorized to work in the U.S. Additionally, our employees are exposed to and have access to certain export-controlled items. Because our employees are provided access to export-controlled items, our policy is to only hire “U.S. persons” who are permitted to have access to our technology without an export license.<br><br>“US person” means: U.S. citizen, U.S. lawful permanent resident, or protected individual as defined by 8 U.S.C. 1324b(a)(3) (i.e., individual admitted to the U.S. as a refugee or granted asylum).</p> <p> </p> <div> <h2><span data-contrast="none">E-Verify Statement</span></h2> <p><span data-contrast="none">Varda Space Industries, Inc. participates in the U.S. Department of Homeland Security E-Verify program. The E-Verify program is an Internet-based employment eligibility verification system operated by the U.S. Citizenship and Immigration Services. Learn more about the <a href="https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.e-verify.gov%2Femployees%2Fe-verify-overview&data=05%7C01%7Ctyree%40varda.com%7C22201ef47a8142f3b0a708dbd0f6e47b%7C1b36161382e94a8784f78a213228882f%7C0%7C0%7C638333531041144158%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=3toCq47V%2FiQtV%2B5rEKFG0tfg0yXkNTv4SuLE2Xy40Rk%3D&reserved=0" data-auth="Verified" data-linkindex="5">E-Verify</a> program.</span></p> <p>E-Verify Notice                                                               Right To Work Notice</p> <p><a>Read more</a>                                                                             <a>Read more</a></p> <p>Varda Space Industries is an Equal Opportunity Employer.  We celebrate diversity and are committed to creating an inclusive environment for all employees. Candidates and employees are always evaluated based on merit, qualifications, and performance. We will never discriminate on the basis of race, color, gender, national origin, ethnicity, veteran status, disability status, age, sexual orientation, gender identity, martial status, mental or physical disability, or any other legally protected status.</p> </div></div>