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The Role:
Moderna is seeking a Drug Product leader to oversee the fill and finish expansion in support of Moderna’s expansive Clinical Research programs in Norwood, MA. She/he will lead, in partnership with Engineering, the start-up and operational readiness of our expanded clinical F/F facility and is responsible to build the needed capability in our clinical Drug Product Plant. She/he is accountable for the development, implementation, and ongoing support of manufacturing business systems and clinical production activities.
She/he will apply existing and new knowledge of Fill & Finish unit operations such as Compounding, Aseptic Filling, Visual Inspection, Labeling and Secondary packaging unit operations and phase appropriate cGMPs to enable technical success with adherence to a Quality System informed by global regulatory expectations. Experience with driving successful facility design and start up, paired with hands on operations experience in a broad range of DP technology are essential success factors for this role.
Here’s What You’ll Do:
Ensure safe and compliant manufacturing operations for the production of mRNA medicines and contribute to the delivery of the clinical demand plan for Moderna’s broad array of phase I, II and III clinical programs.
Develop an Operational Readiness Playbook for Fill & Finish Clinical Operations and lead a cross-functional team on its execution.
Develop the staffing strategy, hiring, onboarding and training for manufacturing employees in collaboration with the DP Plant Leader
Lead Clinical Fill & Finish Project Steering Committee ensuring project implementation timelines are met and aligned with our clinical program priorities
Manage the execution of deliverables, both short and long-term, via clearly defined milestones, and timelines. Minimize timeline deviations by clearly identifying program risks proactively and communication of strategies
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
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.
Foster a strong operations culture which is inclusive, collaborative, engaged, compliant, safety minded and highly personally accountable. Coach team for positive inter-departmental collaboration.
Support the 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.
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
Responsible for establishing the budget and maintaining control of costs
Here’s What You’ll Bring to the Table:
A BS in engineering or sciences and 10+ years of experience (or MS with 8-10 years of experience or PhD with at least 5 years of experience) in all Fill & Finish manufacturing processes in a commercial or clinical environment. Or MS with 8-10 years of ex
Demonstrated ability to build and lead high performing project teams and demonstrated ability to lead cross-functionally through influence with strong communication skills
Hands on operations management and project leadership experience required, Facility Operational start up would be preferred.
Strong ability to proactively define strategy and needed actions, identify & mitigate roadblocks and challenge the cross-functional team to build a best in class operation and drive execution in a very hands on way with dynamic range.
Operational Experience and Technical know-how of F&F units operation including Compounding, Aseptic Filling. Isolator Technology, Lyophilization, Visual Inspection, Label and Secondary Packaging.
Technical writing skills and proficient in investigations and root cause analysis.
Ability to manage multiple new product introductions in a fast-paced environment
Ability to effectively collaborate effectively in a dynamic, fast-paced cross-functional matrix environment
Leverage Lean and Six Sigma principles to foster and drive a culture of continuous improvement
Express Moderna’s core values: Bold – Curious – Relentless – Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
About Moderna
In over 10 years since its inception, Moderna has transformed from a 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 seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. 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 and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit (url removed).
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at (url removed). (EEO/AAP Employer)
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