Associate Director, Intl Manufacturing - Visp

Job content

The Role

Reporting to the Director of Manufacturing International, this position will coordinate and drive cGMP manufacturing activities at Moderna’s Drug Substance Contract Manufacturing Organizations (CMO) to ensure on-time and in-full deliveries. This includes responsibility to ensure all operational related activities at the CMOs are conducted to meet all of Moderna’s requirements.

Here’s What You’ll Do

• Lead supporting efforts at CMOs in executing operational and tactical plans. Partner with Quality, Technical Development, Manufacturing Science and Technology (MS&T), Supply Chain, Legal, Finance and Regulatory on all aspects of the relationships with the CMOs.

• Responsible for ensuring that all operational related activities at the CMOs are conducted to meet Moderna’s requirements (Compliance, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx).
• Oversee Contract Management Process with CMO. Partner with key Procurement, Legal and Finance in the preparation and negotiation of Statements of Work (SOW), Change Orders (CO) and supportive agreements. Ensure contract terms are executed including issuance of purchase orders, forecasts and other deliveries.
• Maintain the integrity of the Master Supply Agreement, ensuring alignment with Quality agreements and appropriate documents.
• Ensure externally manufactured products are produced and stored according to the appropriate documentation in order to obtain the required quality.
• Approve instructions relating to external production operations and ensure their strict implementation by the CMOs
• Ensure in collaboration with quality that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate Moderna’s requirements.
• In collaboration with Quality and MS&T, coordinate investigations and troubleshooting efforts at CMOs
• Review and approve the appropriate GMP documentations as required e.g: change request, deviations, master batch records, annual product quality reviews (APR/PQR), internal SOP´s
• Drive for and implement agreed continuous improvements at CMOs.
• Lead and track life cycle projects at CMOs impacting manufacturing operations, in close collaboration Regulatory, MS&T, Supply Chain and Quality operations.
• Collaborate with internal cross-functional teams to understand needs/expectations for CMO performance. Drive contract manufacturer capability and capacity to enable on-time and predictable delivery of the product.
• Lead periodic reviews and execution of the MPS (Master Production Schedule)
• Frequently visit and maintain presence at the external partners’ sites (50%) and build strong interdependent relationship with CMOs Counterparts in order to assess the as is state & risks for action-oriented improvement plans.
• Deputy of the Manufacturing International Head.
  

Here’s What You’ll Bring To The Table

• Advanced degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering).

• 10+ years’ experience in Pharmaceutical/Biotechnology Industry
• 2+ years in managing contract manufacturing or similar business responsibility.
• Adapts departmental plans and priorities to address resource and operational challenges
• Demonstrated experience in leading cross-functional teams
  

Ability to work in a fluid environment and foster a strong collaborative spirit

Ability to negotiate and sustain networking relationships

Solid judgement with ability to make good decisions

• Outstanding communication skills (verbal and written) to collaborate with senior CMC Management in a dynamic, cross-functional matrix environment
• A leader who is self-reflective and leads by example and drives the organization’s performance with an attitude of continuous improvement by being open to feedback and self-improvement.
• Results oriented – you set a high bar for yourself and others
• Ability to navigate through ambiguity and rapid growth and adapt to change.
• Strong proficiency in English. German is an advantage.
  

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.