Sr. Manufacturing Associate
ModernaTX, Inc.

Job Info

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The Role:

A Manufacturing Associate I, in the Fill Finish Operations, Drug Product group is responsible for final sterile filtration, vial filling, visual inspection, label and packaging (Fill Finish) of Moderna's mRNA Drug Products. This position is located at Moderna's GMP Manufacturing site in Norwood, MA.

The individual in this role will be part of a cohesive team responsible for supporting GMP mRNA-based medicines for evaluation in human clinical trials through execution of sterile filtration, vial filling, visual inspection, and labeling and packaging activities. The successful candidate will be able to document all activities performed following cGMP guidelines and interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Manufacturing Sciences and Technology, Quality Control, Quality Assurance, Logistics and Process Development Technology Transfer counterparts.

Here's What You'll Do:

• Routinely execute sterile filtration, filling, visual inspection, and packaging/shipping using disposable technologies, automation, and Manufacturing Execution Systems (MES).
  
• Demonstrate general knowledge of standard manufacturing practices and equipment.
  
• Tracking and reorder of all filling, labeling, and packaging materials.
  
• Perform fill finish activities for multiple drug product vial types and packaging configurations.
  
• Collaborate with Supply Chain, and maintain inventory and review process orders.
  
• Closely partner with QA and QC peers for execution of fill finish activities.
  
• Support the investigation and troubleshooting of technical and compliance issues.
  
• Maintain individual training compliance as well as support training of various supporting functional groups.
  
• Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.
  
• Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
  
• Practice safe work habits and adhere to Moderna's safety procedures and guidelines.
  
• Ability to manage multiple projects in a fast-paced environment and drive for continuous improvement.
  
• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
  
• Flexibility to work off hours and overtime if needed to meet clinic demand and process schedules.
  

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

• Associates Degree / Biotechnology Certificate / Bachelors of Science with cGMP plus 7 years experience.
  
• Ambitious and self-starting attitude to take on responsibilities and own process improvements.
  
• Experience in electronic batch records, Syncade, OSI PI, eDMS, and SAP preferred.
  
• Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP.
  
• Express Moderna's core values: Bold - Curios - Relentless - Collaborative.
  

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.

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