Sr. Manufacturing Associate I, INT Drug Product, Nights

The Role:

Moderna is seeking a cGMP Sr. Manufacturing Associate I, in the Personal Cancer Vaccines team responsible for manufacturing cGMP mRNA vaccines for evaluation in human clinical trials. This position will be an overnight shift from 6:00 PM to 6:00 AM on a rotating 12 hour schedule. This position is located at our GMP Manufacturing site in Norwood, MA. 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.

Heres What Youll Do:

• Independently executes sterile filtration, filling, visual inspection, labeling and packaging using disposable technologies, automation, and Manufacturing Execution Systems (MES).

• Demonstrates applicable and specific knowledge of standard manufacturing practices and equipment.

• Tracking and reorder of all filling, labeling, and packaging materials.

• Leads/participates in fill finish activities for multiple drug product vial types and packaging configurations.

• Collaborate with Supply Chain, maintain inventory and review process orders.

• Closely partner with QA and QC peers for execution of fill finish activities.

• Responds rapidly and trouble-shoots routine equipment process and digital issues.

• Maintain individual training compliance as well as train others in the manufacturing process.

• Ensure 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 Modernas safety procedures and guidelines.

• Lead/participate in multiple projects in a fast-paced environment and drive for continuous improvement.

• Effectively collaborate in a dynamic, cross-functional matrix environment.

• Adhere to and reinforce gowning procedures and maintain a clean general operating area.

• Flexibility to work off hours and overtime if needed to meet clinic demand and process schedules.

Heres What Youll Bring To The Table:

• Bachelor of Science typically with cGMP with 5-8 years of relevant experience or an Associates Degree, Biotechnology Certificate with 10+ years of relevant experience.

• Ambitious and self-starting attitude to take on responsibilities and own process improvements.

• Demonstrated ability to lead teams and/or projects.

• Experience in digital GXP systems such as Syncade, OSI PI 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 Modernas core values: Bold Curious Relentless Collaborative.

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

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

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 persons 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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