Sr. Specialist, International Fill Finish – Manufacturing Sciences & Technology

☞ Moderna

View: 158

Update day: 26-03-2024

Location: Basel Basel-Stadt BS

Category: IT - Software

Industry: Financial Services Biotechnology Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

The Role

Reporting to the Director, International Fill Finish, the International Fill Finish Senior Specialist is a newly created position and will have the opportunity to collaborate in the definition and buildup of the External Manufacturing Fill Finish function in Europe and Rest of World for Moderna. The International Fill Finish Senior Specialist will liaise with Moderna’s International Fill Finish Contract Manufacturing Organizations (CMOs) to ensure on-time and in-full deliveries. This includes supporting the (Associate) Director, International Fill Finish to ensure all operational related activities at the Fill Finish CMOs are conducted to meet all of Moderna’s requirements. This role will collaborate with other functions locally and in the US to continue to execute on Moderna’s production strategy.

Here’s What You’ll Do
  • Support the (Associate) Director, International Fill Finish in various tasks related to the buildup of GMP production at Fill Finish Contract Manufacturing Organizations (FF CMOs).
  • Act as a counterpart for FF CMOs team members to ensure on-time and in-full deliveries. Partner with Quality, Technical Development, Manufacturing Science and Technology, and Regulatory colleagues on specific aspects of the relationships with the FF CMOs.
  • Ensure operational related activities at the FF CMOs are conducted to meet Moderna’s requirements (Compliance, Meeting Orders, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx).
  • Ensure externally manufactured drug products are produced and stored according to the appropriate documentation in order to obtain the required quality.
  • Ensure that instructions relating to external production operations are strictly implemented by the CMOs
  • Ensure in collaboration with quality that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate Moderna requirements.
  • Support and perform the reviews for process performance at FF CMOs.
  • Monitor Key Performance Indicators of FF CMOs.
  • Support preparation of periodic business and operations review meetings.
  • Drive for and implement agreed continuous improvements at FF CMOs.
  • Coordinate reviews and approvals of various documentations from FF CMOs.
  • In collaboration with Quality coordinate investigations and troubleshooting efforts at FF CMOs
  • Write or revise the appropriate GMP documentations.
  • Frequently visit and maintain presence at the external partners’ sites and build strong interdependent relationship with the CMO Counterparts in order to assess the as is state & risks for action-oriented improvement plans.
  • Performs other administrative duties as required.
Here’s What You’ll Bring To The Table
  • Bachelor’s Degree with 5-8 years of experience in biopharmaceutical operations or a Master’s Degree with 2-5 years industry experience; Degree in Engineering or Life Sciences is preferred
  • Proficiency in English required. Spanish and German are a plus.
  • Good communication skills (verbal and written) to collaborate with other CMC team members and managers in a dynamic, cross-functional matrix environment
  • Ability to work with members of partner organizations (CMOs)
  • Well organized – a natural ability to be organized in how you think, communicate and conduct your work
  • You drive for results – you set a high bar for yourself and others
  • Good critical thinker that can anticipate the needed next step and therefore can work independently
  • A curious mindset that allows you to constantly learn and challenge the status quo
  • Ability to navigate through ambiguity and rapid growth and adapt to change.
About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, 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. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit

Moderna is a smoke-free, alcohol-free and drug-free work environment.
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Deadline: 10-05-2024

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