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Director, INT Manufacturing, DNA - Burlington, United States - Moderna
Description
The RoleIn this role, you will lead the manufacturing team for the DNA Plasmid manufacturing group at the Moderna site in Burlington, MA, and play a key role on the INT Site Leadership Team.
You will also support build of DNA operations at Norwood Moderna Technology Center for initially 20% of the time. You are accountable for the development, implementation, and ongoing support of manufacturing business systems and clinical production activities.In this role you will apply knowledge of bioprocess unit operations and cGMPs to enable technical success with a focus on Operational Safety and adherence to a Quality System respecting global regulatory expectations.
You will play a vital role in the continuing operations and maturation of our Burlington and Norwood, MA facility by procuring and qualifying equipment, developing SOPs, and improving electronic batch records and training materials.
You will hire, train, develop and retain a high-performing, flexible manufacturing team capable of meeting a fast-manufacturing operation timeline.Here's What You'll Do
Lead a team of Managers and Technical Specialists to safely produce DNA Plasmid to support mid-to-late-stage clinical programs.
Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to manufacture and deliver on time.
Lead the strategy and delivery for hiring, training, development, retention, and performance of staff for the leadership and execution of manufacturing operations.
Provide on-the-floor coaching of the manufacturing and support teams on execution of the process and operation within a GMP environment.
Ensure the work center remains in a constant state of inspection readiness.
Closely partner with QA peers for rapid disposition of batches, including ensuring timely batch record, protocol, and log reviews, deviation investigation support, etc.
Working closely with cross-functional peers, develop comprehensive operating plans and monitor the achievement of business and financial goals.
Lead and manage multiple projects alongside operations in a fast-paced environment.
Collaborate in a dynamic, cross-functional matrix environment.
Additional duties as may be assigned from time to time
Here's What You'll Need (Minimum Qualifications)
A BS in engineering or sciences and 15+ years of experience in all manufacturing processes in a pharmaceutical or biotechnology environment or 20+ of relevant GMP experience.
Previous Management experience is requiredHere's What You'll Bring to the Table (Preferred Qualifications)
Project Management experience is preferred
Experience with cell culture / fermentation operations
Excellent communication and presentation skills
Strong leadership, collaboration, and team building skills
Skilled in conflict resolution and crucial conversations (within the team and between functions)
Fluency in digital systems such as SAP, DeltaV, MES, etc.
Technical writing skills and proficient in investigations and root cause analysis.
Strong understanding of manufacturing supply chain systems, including production planning, scheduling, and material management
Proven ability to assess risk and collaborate with support groups to develop suitable action plans and minimize potential impact
Experience in cGMP inspections (with partner companies and/or regulatory agencies)
Subject Matter Expert on the set up/use/process of Bioreactors, TFF Systems, Chromatography systems, single-use process materials/consumables is preferred.
A desire to make an impact as part of a high-growth, transformational company that is
Bold, Relentless, Curious, and Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including:
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team.
We believe in giving our people a platform to change medicine and an opportunity to change the world.By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.
Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visitto learn more about our current opportunities.
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 contact the Accommodations team at. (EEO/AAP Employer)
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