Sr./Engineer, Manufacturing Sciences and Technology
This position is part of Moderna's Manufacturing Science and Technology (MST) team responsible for ensuring the robust technology transfer and technical support of our mRNA platform in cGMP Manufacturing. The individual will work closely within MST, and with Process Development, Manufacturing, Regulatory, and Quality, to ensure all aspects of technology transfer and technical support are successfully executed. The individual will also participate in qualification and startup of process equipment used at Moderna's new cGMP manufacturing operations in Norwood, MA.
Here's What You'll Do:
- Support technology transfer projects including coordination of process information exchange, documentation of process parameters, and tracking process performance.
- Provide technical support of cGMP manufacturing including authoring of technology transfer documents, change control, and manufacturing investigations. Collaborate with process development on studies to determine root cause for deviations.
- Analyze manufacturing performance through data review and analyses. Author manufacturing summary reports. Establish and maintain data repositories.
- Support implementation of new process equipment in manufacturing. Support includes review of design, review of engineering drawings, review / creation of FAT/SAT protocols, technical support of commissioning and validation activities, and lead engineer on startup/engineering runs. Lead cross functional troubleshooting for manufacturing equipment.
- Assist in design and engineering of disposable systems used in bioprocessing including aseptic bioprocessing bags and tubing manifolds. Review design and engineering drawings. Execute studies to demonstrate equipment fit and process performance.
- Author and execute protocols supporting process characterization and equipment scale up in cGMP Manufacturing.
Here's What You'll Bring to the Table:
- Biochemical engineer, Chemical engineer, or Biochemistry background. BS with 5-8 years of experience or MS with 2-5 years experience in a pharmaceutical or biotechnology company.
- Process development or operational experience in chromatography and tangential flow filtration.
- Prior experience providing technical support in a cGMP manufacturing environment.
- Experience in biologics process development or cGMP manufacturing of biologic products.
- Experience in single use bioprocessing technologies.
- Knowledge of data management tools and statistical analysis.
- Experience in cGMP equipment commissioning and validation.
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.
- 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.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.