Senior Director, CMC Development, Biologics

Company Description

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.

Role Summary

Metaphoreis seeking aSenior Director CMC Development & External Manufacturingtolead end-to-end CMC strategy and execution forourbiologicsprograms. This individual will haveprimary accountability for developing fit-for-stage drug substance and drug product processeswith 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 intolate stageCMC work andensure CMC deliverables support regulatory submissions and clinical supply needs.

Key Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Required Qualifications

• Advanced degree (PhD preferred; MS withsignificant experienceconsidered) in Chemical Engineering Biochemistry Pharmaceutical Sciences or related discipline.15 years ofbiologicsCMC experience spanning development through GMP manufacturing and external manufacturing oversight (drug substance and/or drug product).
• 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.
• Demonstrated success managing external collaborations/CDMOs to deliver CMC development and manufacturing outcomes in fast-paced matrixed environments.
• 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.
• Deep working knowledge of cGMP/GxPand quality systems with clear concise communication and stakeholder influence skills.

Desired Skills

• Define and execute strategic vision to advance scientific innovation translating emerging insights into high-impact initiatives roadmaps and measurable outcomes.
• Act decisively and own end-to-end accountability making timely data-informed decisions taking responsibility for results and delivering against commitments in dynamic environments.
• 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.

About Flagship Pioneering

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 humanitys 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.

Flagship has been recognized twice on FORTUNEs 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 Companys annual list of the Worlds Most Innovative Companies. Learn more about Flagship at.

At Flagship we accept impossible missions to enable bigger leaps. Ourcore valuesguide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. 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.

We recognize that great candidates often bring unique strengthswithout fulfilling every qualification. 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 backgroundand interest in Flagship.

Recruitment & Staffing Agencies: 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 Pioneerings 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.

The salary range for this role is $213000 - $280500. Compensation for the role will depend on a number of factors including a candidates 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.

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