Director of CMC at Varda Space Industries

El Segundo, California, United StatesFull-timeProductPosted about 1 month ago

About the Role

<div class="content-intro"><h2>About Varda</h2> 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.  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.  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.  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. Join Varda, and work to create a bustling in-space ecosystem.</div><h2>About this Role</h2> Our pharmaceutical team is looking for a highly motivated and creative Director of Chemistry, Manufacturing and Control (CMC) to lead expansion and growth of partner pharma activities toward clinical production. This role will be responsible for all CMC activities across the external drug development pipeline of Varda’s partners. Reporting to the VP, Pharma Program Management), this position requires collaboration across multiple departments and external partners to design, develop, and implement novel approaches to manufacture drug products in low Earth orbit. This is an opportunity in an exciting area of growth for Varda, the role will shape Varda’s product culture and will play a significant role in establishing the low Earth orbit economy. The ideal candidate must create and lead the CMC development team for drug products from early stage through clinical manufacturing. <h2 style="line-height: 1.5;">Responsibilities</h2> <ul> <li>Develop and lead all GMP CMC-related activities (biologics and small molecule) including process chemistry, drug product, analytical, and formulation from lead optimization phase through to clinical development and commercialization  </li> <li>Build and lead internal GMP CMC team with functions around process development, quality control, and quality assurance. </li> <li>Manage external drug product manufacturing service providers and API supply chains to support clinical trial development  </li> <li>Collaborate with Varda pharma R&D teams to understand future CMC needs and handle internal tech transfers </li> <li>Author all CMC sections of regulatory filings including FDA, EMA and other national authorities to support the conduct of clinical trials </li> <li>Act as subject matter expert for non-clinical CMC to both preclinical and clinical development teams, interact with all internal and external stakeholders to support CMC needs </li> <li>Ensure high-quality standards, develop SOPs, implement GMP compliance and QC/QA </li> <li>Monitor progress and regularly report to the C-suite team </li> <li>Manage and monitor the CMC timelines and budget </li> </ul> <h2>Basic Qualifications</h2> <ul> <li>8+ years of CMC leadership experience advancing drug product development programs to successful clinical trials </li> <li>B.S. or M.S. in life sciences such as Chemistry, Biochemistry, or related fields </li> <li>Firm understanding of cGMP and FDA regulatory guidelines as they pertain to CMC </li> </ul> <h2>Preferred Skills and Experience</h2> <ul> <li>12+ years of CMC leadership experience advancing drug product development programs to successful clinical trials </li> <li>PhD in life sciences such as Chemistry, Biochemistry, or related fields </li> <li>Documented evidence of prior successful CMC project leadership from early phase, late phase leading to clinical trials. </li> <li>Experience in leading and direct management of research, analytical laboratories, process development, and manufacturing </li> <li>Advanced understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas </li> <li>Command of global CMC-related regulatory requirements and guidelines </li> <li>Excellent leadership, managerial and communications skills in a cross functional environment </li> <li>Hands-on experience in managing multiple internal and external stakeholders (e.g. working with CMOs on managing drug product development) </li> <li>Experience with writing CMC sections for regulatory filings and knowledge of current regulations in US and EU </li> <li>Fluent communication in English, written and verbal </li> </ul> <h2>Pay Range</h2> <ul> <li>Salary range: $200,000 - $230,000/per year</li> <li>This role is on-site 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 incentives in the form of stock options and/or long-term cash awards</li> </ul><div class="content-conclusion"><div> <h2>ITAR Requirements</h2> </div> <ul> <li> 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. At present, some of our technology to which employees have access requires a license to be exported to individuals other than “U.S. Persons” as defined in U.S. export regulations. Because our employees are provided access to export-controlled items, our current policy is to only hire “U.S. persons” who are permitted to have access to our technology without an export license.  “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 in the U.S.)  Learn more about the ITAR <a href="https://www.pmddtc.state.gov/?id=ddtc_kb_article_page&sys_id=24d528fddbfc930044f9ff621f961987">here</a>.  </li> </ul> <h2>Benefits</h2> <div> <ul> <li>Exciting team of professionals at the top of their field working by your side</li> <li>Equity in a fully funded space startup with potential for significant growth (interns excluded)</li> <li>401(k) matching (interns excluded)</li> <li>Unlimited PTO (interns excluded)</li> <li>Health insurance, including Vision and Dental</li> <li>Lunch and snacks provided on site every day. Dinners provided twice a week. </li> <li>Maternity / Paternity leave (interns excluded)</li> </ul>   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.   <h2>E-Verify Statement</h2> 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. E-Verify Notice                                                               Right To Work Notice <a>Read more</a>                                                                             <a>Read more</a>   </div></div>

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