Senior Director, CMC Development, Biologics

<p> </p> <p><strong>Company Description</strong></p> <p><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Metaphore Biotechnologies, Inc. is a privately held biotechnology company building the next generation of biological therapeutics. Inspired by nature, our mission is to transform patient lives by unlocking the power of biological therapeutics with a new mimic-discovery platform.</span></span><span data-ccp-props="{"134233117":true,"134233118":true}"> </span></p> <p> </p> <p><strong><span data-contrast="auto">Role Summary</span><span data-ccp-props="{}"> </span></strong></p> <p><span data-contrast="auto">Metaphore is seeking a Senior Director, CMC Development & External Manufacturing to lead end-to-end CMC strategy and execution for our biologics programs. This individual will have primary accountability for developing fit-for-stage drug substance and drug product processes with external manufacturing CDMOs. This leader will own the integrated CMC plan (strategy, timeline, budget, and risks), partner with key internal stakeholders to enable seamless transition into late stage CMC work and ensure CMC deliverables support regulatory submissions and clinical supply needs. </span><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="auto">Key Responsibilities</span><span data-ccp-props="{}"> </span></strong></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Own end-to-end CMC strategy and execution, including governance, integrated plans (timeline/resources/interdependencies), scenario planning, supply forecasting, and risk management to deliver program and company milestones. </span><span data-ccp-props="{}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Lead external CDMO strategy and oversight for drug substance and drug product (scope setting, operating cadence, deliverables/action tracking, issue escalation/resolution), ensuring execution success. </span><span data-ccp-props="{}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Provide technical leadership across upstream/downstream, analytical, formulation, fill/finish, and stability, guiding fit-for-stage development decisions (e.g., scale-up strategy, formulation/container strategy, stability approach) and tech transfer readiness. </span><span data-ccp-props="{}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Ensure phase-appropriate GMP readiness and campaign execution at the CDMO, including deviation/change/CAPA alignment with Quality and ensuring testing and disposition timelines support clinical needs. </span><span data-ccp-props="{}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Drive CMC regulatory deliverables (CMC sections of submissions/amendments) and executive-level communication of status, decisions, risks, and mitigation plans; build/lead high-performing internal and matrixed teams. </span><span data-ccp-props="{}"> </span></li> </ul> <p><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="auto">Required Qualifications</span><span data-ccp-props="{}"> </span></strong></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Advanced degree (PhD preferred; MS with significant experience considered) in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline. 15+ years of biologics CMC experience spanning development through GMP manufacturing and external manufacturing oversight (drug substance and/or drug product).</span><span data-ccp-props="{}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Proven ability to define CMC strategy and translate it into cross-functional deliverables, integrated plans, timelines, and budgets, with strong program leadership and operating rigor. </span><span data-ccp-props="{}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Demonstrated success managing external collaborations/CDMOs to deliver CMC development and manufacturing outcomes in fast-paced, matrixed environments. </span><span data-ccp-props="{}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Strong technical breadth in at least one major CMC area (and ability to lead across all), including upstream/downstream, analytics, and/or fill/finish/drug product with stability/tech transfer exposure. </span><span data-ccp-props="{}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Deep working knowledge of cGMP/GxP and quality systems, with clear, concise communication and stakeholder influence skills. </span><span data-ccp-props="{}"> </span></li> </ul> <p><span data-ccp-props="{"335559685":720}"> </span></p> <p><strong><span data-contrast="auto">Desired Skills</span></strong><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1268,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Define and execute strategic vision to advance scientific innovation, translating emerging insights into high-impact initiatives, roadmaps, and measurable outcomes.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":810,"335559740":278,"335559991":450}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1268,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Act decisively and own end-to-end accountability, making timely, data-informed decisions, taking responsibility for results, and delivering against commitments in dynamic environments.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":810,"335559740":278,"335559991":450}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1268,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Build change-agile, high-performing teams and networks, growing others through coaching and development, modeling strong self-awareness, and cultivating relationships with external thought leaders to accelerate learning and partnerships.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":810,"335559740":278,"335559991":450}"> </span></li> </ul> <p> </p> <p><strong>About Flagship Pioneering</strong></p> <p>Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.  </p> <p>Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship at <a href="https://nam12.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.flagshippioneering.com%2F&data=05%7C02%7Cemccurdy%40flagshippioneering.com%7C8e54295c994c4d440a7b08ddc94a4a72%7Cd00b8682fc8b4548b82dda0524788e9b%7C0%7C0%7C638888043086011906%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=gknIK%2BmYfQpsSi0%2FyQmhzNBo4DurYfmbUQpruIKf6Mc%3D&reserved=0">www.flagshippioneering.com</a>.</p> <p>At Flagship, we accept impossible missions to enable bigger leaps. Our <a href="https://www.flagshippioneering.com/values">core values</a> guide us through uncertainty and toward lasting impact.</p> <p> </p> <p><strong>We are an equal opportunity employer</strong>. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.</p> <p>We recognize that great candidates often bring unique strengths <strong>without fulfilling every qualification</strong>. If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background<strong> and interest in Flagship.</strong></p> <p><strong><em>Recruitment & Staffing Agencies</em></strong><em>: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.</em></p> <p> </p><p id="pay-transparency" style="margin: 0 !important; padding: 0 !important; float: none !important; clear: both !important; display: block;">The salary range for this role is $213,000 - $280,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Metaphore Biotechnologies, Inc. currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Metaphore Biotechnologies, Inc.'s good faith estimate as of the date of publication and may be modified in the future.</p>