The Role:
Moderna is seeking a senior leader of Clinical Manufacturing to oversee the production of mRNA medicines in support of Moderna s expansive Clinical Research programs (not including mRNA-1273 COVID Vaccine). He/she will lead the multiple manufacturing teams responsible for supplying clinical drug product to the Personal Cancer Vaccine Unit as well as the Therapeutic Areas teams with programs in the clinic. She/he is accountable for the development, implementation, and ongoing support of manufacturing business systems and clinical production activities. The individual in this role will lead a cohesive team of supervisors responsible for supporting the manufacturing of Clinical mRNA-based medicines. He/she will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with adherence to a Quality System informed by global regulatory expectations. She/he will play a vital role in the continuing operations and maturation of our new Norwood, MA facility by procuring equipment, developing SOPs, improving electronic batch records and training materials. They will oversee the hiring, training and capability building, team development and engagement a high-performing and flexible organization.

Here s What You ll Do:
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Ensure safe and compliant manufacturing operations for the production of mRNA medicines and contribute to the delivery of the clinical demand plan including Moderna s PCV and a broad array of phase I, II and III clinical programs.
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Manage the execution of deliverables, both short and long-term, via clearly defined milestones, and timelines. Minimize timeline deviations by clearly identifying program risks and communication of strategies
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Set clear objectives, monitor and report on performance of your team in key areas including Quality, Safety, Delivery, and People. Mitigate and escalate risks to the appropriate level
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Coordinate and integrate the activities of upstream and downstream operations colleagues and other cross-functional partners to ensure alignment in scope, schedule and budget. Ensure resources are being utilized on the most impactful activities.
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Foster a strong operations culture which is inclusive, collaborative, engaged, compliant, safety minded and highly personally accountable. Coach team for positive inter-departmental collaboration.
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Build and develop a high-performing manufacturing team, including operations management, ensuring the right skills are added at the appropriate time during periods of rapid growth.
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Drive continuous improvement activities and operational excellence, including reduction of cycle time and cost and contribute to the development of batch records, SOPs and training materials for the Norwood Facility
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Responsible for establishing the budget and maintaining control of costs

Here s What You ll Bring to the Table:
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A BS in engineering or sciences and 15+ years of experience in all manufacturing processes in a pharmaceutical or biotechnology environment.
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Demonstrated ability to build and lead high performing teams.
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management or project experience is required
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Subject Matter Expert on the set up/use/process of major bioprocess unit operations such as TFF Systems, Chromatography systems. Single-use process materials/consumables is preferred.
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Technical writing skills and proficient in investigations and root cause analysis.
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Experienced with cGMP in pre-clinical and commercial manufacturing environments.
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Experience of overseeing 24/7 operations preferred.
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Ability to manage multiple projects in a fast-paced environment
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Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
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Leverage Lean and Six Sigma principles to foster and drive a culture of continuous improvement

Here s What We ll Bring to the Table:
- On-site subsidized cafeteria or catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass or a subsidized commuter rail pass
- Free annual corporate membership to Bluebikes
- Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 16 weeks of 100% paid parental leave for all new parents
- 16 weeks 100% paid family caregiver leave
- 20 weeks 100% paid medical leave
- 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)
- Adoption assistance and discounts to local childcare centers, as well as access to care.com
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 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)

About Moderna:
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science s list of top biopharma industry employers for the past five years. To learn more, visit .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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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