Full-Time

Executive Director

Global Engineering

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines and therapies

Biotechnology
Healthcare

Senior, Expert

Norwood, MA, USA

70% in-office presence required.

Category
Data Engineering Management
DevOps Engineering Management
Security Engineering Management
Quality Assurance Management
Engineering Management
Software Development Management
Product Engineering Management
Systems Engineering Management
Requirements
  • 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).
  • 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.
Responsibilities
  • 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.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a molecule that provides instructions for cells to produce proteins essential for various biological functions. Their approach involves creating a new class of medicines that leverage mRNA to potentially enhance the discovery, development, and manufacturing of drugs. Unlike traditional methods, which often rely on proteins or other biological materials, Moderna's use of mRNA allows for a more versatile and efficient way to create treatments. The company's goal is to improve patient outcomes by harnessing the power of mRNA to address a wide range of health issues.

Company Stage

Grant

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

N/A

Growth & Insights
Headcount

6 month growth

3%

1 year growth

12%

2 year growth

54%
Simplify Jobs

Simplify's Take

What believers are saying

  • Moderna's expansion into combination vaccines and autoimmune therapies showcases its potential for diversified revenue streams and market leadership.
  • The company's continuous innovation and FDA approvals for updated COVID-19 vaccines highlight its resilience and adaptability in a rapidly changing market.
  • Moderna's educational initiatives, like the free mRNA course, position it as a thought leader and advocate for mRNA technology.

What critics are saying

  • The collapse in demand for COVID-19 vaccines could significantly impact Moderna's revenue and growth prospects.
  • Ongoing class action lawsuits alleging securities fraud could damage Moderna's reputation and financial stability.

What makes Moderna unique

  • Moderna is pioneering the use of mRNA technology to create a new class of medicines, setting it apart from traditional pharmaceutical companies.
  • The company's focus on mRNA as the 'software of life' allows for rapid development and manufacturing of vaccines and therapies, unlike conventional methods.
  • Moderna's ability to secure regulatory approvals for mRNA vaccines beyond COVID-19, such as for RSV, demonstrates its leadership in mRNA technology.

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