The Role
In this technical leadership role, one which has primary responsibility for leading the conceptual and detailed engineering of new manufacturing and R&D facilities worldwide, you will lead a group of subject matters experts across multiple disciplines including Plasmid, mRNA Drug Substance, mRNA Drug Product Manufacturing, Plant and Clean Utilities including HVAC. The position requires broad engineering knowledge of the Drug Substance and Drug Product Manufacturing Technologies. It also requires strong project management skills with the ability to keep multiple projects on their timelines and on budgets in a fast based and demanding environment. Candidate must have a strong process approach and an eye toward continuous improvement with as are strong organizational skills and written and verbal communication skills.
Candidate should have knowledge of regulatory and performance requirements for pharmaceutical manufacturing facilities. Candidate will establish and lead a local team of project delivery and manufacturing support resources (Process Engineering for Drug Substance and Drug product Manufacturing, Plant and GMP Utilities) at remote locations for project execution. Candidate would be responsible for overall project delivery up to Operational Readiness milestone.
Travel to support global manufacturing expansion could be up to 25% at critical project phases.
Here’s What You’ll Do
- Partners with the Capital Project Delivery and Project Control Team in the delivery of manufacturing, Office, and R&D facilities worldwide.
- Lead combines technical team of mRNA Drug Substance process engineer, facilities and utilities engineers, process improvement, Sterile Filling, Automatic Inspection and Packaging, on capital projects delivery in compliance with regulatory standards.
- Ensure good engineering practices are followed through for the performance of control and coordination activities on all process phases (planning, development, approval, and implementation); integration and synergies between Global and local requirements; ensure maintenance and operations best practices and guidelines sharing across Moderna’s mfg. network
- Strategic and tactical leadership of design, construction, commissioning, qualification (if applicable) and operational readiness workstreams for capital project portfolio.
- Partner with MS&T (Manufacturing Sciences & Technology) (Manufacturing Sciences & Technology) and Technical Development organizations in the development of novel manufacturing technologies around Moderna’s mRNA platform.
- Provide input to short- and long-term capital planning
- Own and drive energy reduction program for the site through conservation, new equipment, and technologies to reduce overall costs and drive sustainability
- Working closely with procurement, direct the bid evaluation and contract award processes and coordinate the negotiation of contracts with engineering firms, process equipment vendors, skid, and oversight of equipment acquisition activities
- Provide leadership in the management of external design team professionals from project inception through completion and ensure they produce thorough and accurate drawings which comply with all established standards
- Ensure review of all construction drawing documents and specifications, coordinating necessary reviews with business unit representatives and regulatory authorities
- Coordinate with internal stakeholders to insure efficient and timely turnover of space for effective operations, including a maintenance and calibration package
- Oversee relationship with the local municipality authorities for project permitting and other business related to site improvements
- Recruit and hire top engineering talent
- Grow and mentor process engineering teams at manufacturing sites
- Work with the Engineering leadership to scale the engineering organization as required by Moderna’s growth.
- Additional duties as may be assigned from time to time
Here’s What You’ll Need (Basic Qualifications)
- At least 20 years of relevant experience working with engineering project delivery, construction capital projects or 15+ years with master's degree in engineering, preferably in a pharmaceutical/FDA-regulated work environment.
- A professional and advanced degree in Engineering. Chemical Engineering background is preferred.
- 10 or more years’ experience leading others on project teams, interfacing and influencing at executive levels.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
- Substantial operational engineering experience
- Broad knowledge of engineering aspects associated with pharmaceutical drug substance and drug product manufacturing
- Knowledge of Quality Assurance (QA) and Environmental, Health & Safety (EHS) standards
- Experience working to regulatory standards: FDA (Food and Drug Administration), Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP)
- Experienced working on all aspects of capital projects, including budgeting, design, construction, validation, start-up, and ongoing operations will be a plus.
- Relevant experience in Central Utilities including, but not limited to: WFI (Water for Injection), and Purified Water, Compressed Air, N2, Chilled Water, Steam, Heating Hot Water, Electricity and Sewage
- Excellent negotiation, organizational, interpersonal, and problem-solving skills
- Working Knowledge of Large and Small Molecule manufacturing including fermentation and chemical synthesis. Single use Systems for Upstream and downstream processing. Fill & Finish experience is a plus.
- Working knowledge if key Drug Substance manufacturing technologies such as Fermentation, Tangential Flow Filtration, Chromatography
- Working knowledge if key Drug Product manufacturing technologies such as Aseptic Filling, Isolator Technology, Automatic Visual Inspection, Label & Packaging and Robotics
- Demonstrates strategic enterprise thinking, finding innovative ways to deliver results, and build trust
- Must possess outstanding communication, analytical, and problem-solving skills, and the ability to work with enterprise-wide information systems
- Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.
- Ability to represent Moderna’s interests, objectives, and policies in a professional and responsible manner.
- Ability to make effective oral presentations and work as part of a team.
- Ability to represent Moderna’s interests, objectives, and policies in a professional and responsible manner.
- 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:
- Vacation, sick time and holidays
- Volunteer time to participate within your community
- Discretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 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, the infrastructure 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.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. 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 visit modernatx.com/careers to 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
