Sr. Director, Global Engineering
Reporting to the SVP Facilities and Engineering, based at our Norwood, MA site, the Senior Director of Global Engineering is a technical leadership position at the organization, one which has primary responsibility for leading the conceptual and detailed engineering of new manufacturing and R&D facilities worldwide. The candidate will lead a group of subject matter 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-paced and demanding environment. Candidate must have a strong process approach and an eye toward continuous improvement with 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 Will Do:
- Partner with the Capital Project Delivery and Project Control Team in the delivery of manufacturing, Office, and R&D facilities worldwide.
- Lead a combined technical team of mRNA Drug Substance process engineers, 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 manufacturing 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) 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.
- Work 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 ensure 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.
Here’s What You Will Bring to the Table:
- 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.
- 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).
- Experience 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 of key Drug Substance manufacturing technologies such as Fermentation, Tangential Flow Filtration, Chromatography.
- Working knowledge of 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.
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.
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.
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