Sr. Associate, GMP Manufacturing Support

The Role:

Reporting to the Senior Manufacturing Manager, the Manufacturing Associate will be part of a dynamic team responsible for Moderna’s manufacturing activities at 3rd-party mRNA Drug Substance contract manufacturing organizations (CMO). The candidate will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The candidate will coordinate cGMP manufacturing activities and documentation for the acceleration of the COVID mRNA-1273 project internationally, and further projects coming via our pipeline. The role will work cross-functionally with other partner groups (MS&T, Quality, Supply Chain, etc.) to assist in planning activities, deviation management, and document coordination.

Here’s What You’ll Do:

• Work cross-functionally to assist in planning CMO activities, batch record review, deviation management, and project initiatives.

• Perform batch record review and approval at CMO to support on time batch release.

• Coordinate reviews and approvals of various CMO documentation as required.

• Write or revise and approve the appropriate GMP documentations. e.g.: change request, deviations, master batch records.

• Coordinate and support investigations and troubleshooting efforts at CMOs, in collaboration with Quality and MS&T

• Lead small cross-functional teams to drive manufacturing operations changes or improvements

• Attend daily operational meetings at the CMO.

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

• Education: University degree in a technical discipline related to Pharmaceutical Manufacturing (e.g. Pharmacy, chemistry, biotechnology, engineering)

• Experience: entry-level position

• Ability to manage multiple competing priorities in a fast-paced environment

• Strong proficiency in English. German or Spanish as an advantage.

About Moderna:

In 10 years since its inception, Moderna has 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. 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 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. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com .

Moderna is a smoke-free, alcohol-free and drug-free work environment.