Engineer III, MS&T Drug Product
ModernaTX, Inc.

Job Info

---

The Role:

This is a newly created role in the Manufacturing Science and Technology (MST) department to support Moderna's aseptic (sterile) drug product fill and finish internal manufacturing and external Contract Manufacturing Organization activities in the USA. Based in Norwood, MA, this role will provide direct support for aseptic drug product fill and finish technology transfer, process start up, process validation and commercial cGMP manufacturing including cross site technical issues/investigations.

Reporting to the Director, Drug Product, MS&T, the incumbent will work alongside Moderna manufacturing operations and Quality Assurance to ensure robust, compliant cGMP drug product manufacturing performance internally and at CMOs within the USA to meet production schedules.

Here's What You'll Do:

• Be a subject matter expert (SME) for drug product fill/finish (aseptic manufacturing) processes at Moderna's CMOs.
  
• Work with a Moderna Drug Product team (Operations, QA, Supply Chain), to be a point of contact for technical issues that occur at CMOs.
  
• Provide technical support of cGMP manufacturing including supporting technology transfer documentation, 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.
  
• MS&T may periodically support weekend coverage for Manufacturing.
  

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

• BS, M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.). BS with 5 to 8 years of experience or MS with 2 to 5 years experience in a pharmaceutical or biotechnology company.
  
• Experience in cGMP aseptic (sterile) fill finish operations including prior experience supporting validation of aseptic manufacturing processes.
  
• Knowledge of data management tools and statistical analysis.
  
• Excellent judgment and ability to communicate manufacturing issues in a scientifically sound and understandable way along with ability to provide data driven solutions.
  
• A highly collaborative team player capable working in a cross-functional matrix environment.
  
• Ability to manage projects in a fast-paced environment.
  
• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
  

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

• On-site subsidized cafeteria or catered lunches
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Free annual corporate membership to Bluebikes
• 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
• Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
• 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 (includes 2 floating holidays)

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 10 years since its inception,Modernahas transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.Modernamaintains 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 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 auto-immune diseases.Modernahas been named a top biopharmaceutical employer bySciencefor 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.

#LI-KS1
-

This job has expired.