Distinguished Fellow Technical Development

Profile

The Role: 

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Moderna is seeking a senior leader, Executive Director for Technical Development with a cross functional leadership responsibility for technical teams. This will involve defining and leading several Technical Development and CMC initiatives for defining and delivering on key development strategies and outcomes for Moderna’s mRNA platform, as well as working on the interface and transition of these initiatives from development to commercial. This role will report to the SVP, Technical Development and will be a member of the Technical Development Leadership team. To be successful in this role you’ll work highly cross-functional across Technical Development and beyond including GMP Operations, Supply Chain, Finance, HR, CMC and R&D Strategy. The role is based in Moderna’s new Moderna Technology Center campus in Norwood, MA.

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Here’s What You’ll Do:  

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  Lead several key technical development initiatives, including planning and implementation of product and process development strategies.

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  Lead strategic external relationships with academic and industry to supplement internal development efforts.

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  Provides strategic direction, oversight, and technical expertise for key initiatives.  

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  Based on strong scientific and engineering principles, define phase appropriate, and risk-based development strategies to lead and support key initiatives from clinical development to commercial manufacture.

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  Act as liaison (with regulatory and quality personnel) with FDA, EMEA and other regulatory agencies for the key initiatives.

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  Provide CMC strategy and guidance, as appropriate.

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  Mentor and develop the technical development staff to function effectively in cross-functional teams and collaborations.

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  Interact effectively and transparently with functional heads and stakeholders within Moderna, (TDLT, Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Clinical and Commercial Manufacturing, Project Leadership, Business Development, Alliance Management, etc.).

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  Hold reviewer/approver/author responsibility for appropriate CMC sections of regulatory submissions

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Here’s What You’ll Bring to the Table: 

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  PhD in Chemical/Biochemical Engineering, or a related discipline with technical experience relevant areas to Moderna’s mRNA platform.

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  Experience with cGMP, process development/ scale-up and methods /process validation is preferred with 15 years of industry experience in process development and/or manufacturing sciences and technology.

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  Demonstrated success building and leading cross-functional teams as well as mentoring staff.

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  Prior experience in a fast-paced environment with demonstrated ability to leverage external collaborations with industry and academic partners

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  Demonstrated understanding of the Development Lifecycle from R&D through commercialization, including an understanding of the interdependencies of functional groups.

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  Strong Experience in Product Development and commercialization

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  Experience in late-stage Development, corporate strategy, budget processes, project management, including outstanding executive communication skills and ability to operate effectively in ambiguity by anticipating and balancing needs of multiple stakeholders

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  Demonstrated experience managing interdisciplinary development teams; exceptional skills at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.

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  Current knowledge of US, EU, Japan and ICH regulatory requirements among others.

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  Strong written and oral communication skills

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  Experience with novel process and product development is desirable

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Here’s What We’ll Bring to the Table:

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• On-site subsidized cafeteria or catered lunches
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• Company-provided iPhone
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• Free parking, monthly subway pass or a subsidized commuter rail pass
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• Free annual corporate membership to Bluebikes
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• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
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• Flexible Spending Accounts for medical expenses and dependent care expenses
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• 16 weeks of 100% paid parental leave for all new parents
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• 16 weeks 100% paid family caregiver leave
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• 20 weeks 100% paid medical leave
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• Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
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• Adoption assistance and discounts to local childcare centers, as well as access to care.com
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• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
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• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
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• Voluntary legal assistance plan
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• 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)
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Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

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About Moderna

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In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic.

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Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit ****rel=no-follow target=_blank>****is a smoke-free, alcohol-free and drug-free work environment.

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Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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