Engineer II, PVU Technical Development

Engineer II, PVU Technical Development

The Role:

Moderna is seeking an experienced process engineer to join the Personalized Vaccines Unit (PVU) for a position based at their Cambridge, MA site. The incumbent will work closely with PVU management, focused on process development and technical transfer activities in support of manufacturing of Moderna's innovative personalized cancer vaccines. He/she will work with the PVU Process and Analytical development teams, GMP Operations and Quality Assurance groups.

At Moderna, we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. The Personalized Vaccines Unit (PVU) is focused on advancing Moderna's fundamental understanding of the science of RNA and LNP production and translating it to the application of patient-specific manufacturing.

The candidate will drive application of fundamental scientific and engineering principles to characterize our drug substance and drug product formulations and processes, with a focus on the Personalized Cancer Vaccine. Working closely with the Drug Substance Development and Drug Product Process Development teams, the applicant will take a lead role in establishing a new advanced manufacturing capability for personalized vaccines at Moderna's internal manufacturing sites, supporting the sending unit as a member of the joint process transfer team. The successful candidate must be able to work in a dynamic environment, will have strong technical skills in a related field, and will have strong written and verbal communication skills. May require some travel to Moderna's Norwood manufacturing facility during the process technical transfer as well as during the initial phase of GMP manufacturing campaigns.

Here's What You'll Do:

• Using risk-based approaches and a deep understanding of chemistry and engineering principles, design and conduct experiments to identify and optimize critical process parameters and characterize early and late stage drug product manufacturing processes
• Collaborates with the Automation Engineering function on concept development and detailed design of process specific custom cGMP manufacturing equipment.
• Collaborate on development of single use assemblies, and characterization of E&L for product contact components.
• Support personalized vaccines manufacturing at Moderna's internal manufacturing sites, representing the sending site as a member of the joint process transfer team
• Contributes to process definition, facility fit assessment, and development of Batch Production Records.
• Provide on-floor supervision and technical support throughout the technical transfer campaign, including pilot and engineering studies.
• Support investigational activities in support of GMP operations, including review of investigational reports. Contribute to change control and process improvement initiatives as needed.

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

• Bachelors 2-5 years, Masters 0-2 years relevant experience in research, development, or manufacturing of biologics
• Knowledgeable of bioprocess purification unit operations as applied to protein, viruses, DNA, RNA, or similar biomolecules.
• Proven ability to work on multi-disciplinary development, technical operations or manufacturing teams.
• Demonstrated ability to manage own time and deliver to program timelines.
• Familiar with cGMPs as applied to large biomolecule production and purification.
• Exceptional written and oral communication skills

• Prior experience with technical transfer (sending or receiving) to a GMP bio-manufacturing facility.
• Significant expertise with laboratory scale chromatography and tangential flow filtration unit operations.
• Experience with deviation management, process change control, and process improvement
• A proven track record of success in positions of increasing responsibility.

Here's What We'll Bring to the Table:

• Daily on-site catered lunches
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 16 weeks of 100% paid parental leave for all new parents
• 16 weeks 100% paid family caregiver leave
• 20 weeks 100% paid medical leave
• Adoption assistance and discounts to local childcare centers, as well as access to care.com
• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
• Voluntary legal assistance plan
• 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays

Why join Moderna Therapeutics

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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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.