Sr. Manager, Process Engineering, Small Scale Mrna

The Role:
Reporting to the Senior Director of F&E – MTC-S, the Senior Manager Process Engineering will be the subject matter expert (SME) for the Small-Scale mRNA Manufacturing Unit Operations at Moderna, including Plasmid, Drug Substance and Drug Product Manufacturing. The candidate will lead a team of Small-Scale mRNA manufacturing System Owners which collaborate with Global Engineering in the process equipment acquisition and delivery effort while once turnover for operations they remain accountable for process improvement, equipment performance and reliability, and overall ownership of the specific manufacturing unit operations. The system owner team acts as the owner of the Small-Scale mRNA process equipment throughout its lifecycle by working closely with Manufacturing, Facilities & Engineering, MS&T, Quality, and other applicable disciplines.
Additionally, candidate will also play an active role in providing guidance to existing manufacturing clinical and small-scale operations and provide technical guidance in overall aspects of cGMP manufacturing.
Candidate should have knowledge of regulatory and performance requirements for process equipment used in the manufacture of pharmaceutical products and able to generate or review and approve project documentation such as URS, functional descriptions, as well as complete Factory Acceptance Testing (FAT) in vendor locations or in the commissioning phase of projects in the field. This individual may lead small scale projects in the Small-Scale mRNA Process Engineering discipline and will likely drive more than one project at a time. The Senior Manager Process Engineer will interact closely with vendors, consultants, clients, and project leadership in providing leadership, technical and engineering solutions.
Here’s What You’ll Do:

• Drive development of Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required
• Provide technical guidance, coaching, and work prioritization assistance with the Process Engineers.
• Manage and lead the System Owner team responsible for Small Scale mRNA Plasmid, Drug Substance and Drug Product Manufacturing support for the Moderna Norwood MTC-S Building
• Responsible for process equipment specification development.
• Troubleshooting equipment to determine root cause of failure modes, providing input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.
• Drive results by owning and completing capital projects and meeting the project timelines to ensure the schedule is not impacted.
• At the level of Senior Manager the candidate must be able to drive results on multiple complex assignments simultaneously, in addition to reviewing and guiding the work and performance of vendors and consultants.
• Provide direct engineering and Subject Matter Expertise for process equipment including Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, Small Scale Fermentation Process and small batch Sterile Filling, clinical DP Inspection, Labeling and Packaging.
• The Senior Manager Process Engineering will participate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.

Here’s What You’ll Bring to the Table:

• Familiarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred.
• 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.
• Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence decisions. Technical writing skills required.
• Minimum of 10 years relevant experience in a Process Engineering related role
• Must be able use his/her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems.
• 10 years of experience in a GxP environment preferred
• Experience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc)
• A bachelor’s degree in Chemical or Mechanical Engineering or other Life Science related field

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Location-specific perks and extras!
• Paid sabbatical after 5 years; every 3 years thereafter
• Dedicated care coordination support for our LGBTQ+ community
• Discretionary year-end shutdown
• Exclusive preferred pricing on Peloton fitness equipment
• Generous paid time off, including:
• 401k match and Financial Planning tools
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Free premium access to fitness, nutrition, and mindfulness classes
• Volunteer time to participate within your community
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Highly competitive and inclusive medical, dental and vision coverage options
• Vacation, sick time and holidays
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Adoption and family-planning benefits
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
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 www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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