Third Party Manufacturing Account Manager
The Third Party Manufacturing (TPM) Management Group is a small team with a decentralized and adaptable structure that aligns with all stakeholder within Operations to deliver rigorous oversight of Third Party Manufacturing Operations for key late pipeline and newly commercialised small molecule products
Key Responsibilities Include:
Key Responsibilities Include:
- The TPM Account Manager will oversee third party manufacturing operations of first tier small molecule and drug linker TPM partners across multiple countries, to assure high quality product is delivered according to the forecasted demand to Abbvie manufacturing sites.
The Account Manager will work with and influence TPMs to:
- Act as key point of contact for TPM on all operational aspects - equipment, performance, cycle time, yield etc.
- Interface with Operations Pipeline teams to ensure that all TPM's are supplying key intermediates and drug linkers to Abbvie sites and other biologic TPM's
- Build solid relationships with first tier TPM's and drug linker TPM's to monitor manufacturing performance weekly through the application appropriate performance metrics and campaign (pre/post) reviews.
- Proactively work with TPM's to ensure work processes and standards align to deliver product in accordance with AbbVie quality expectations.
- Informing various internal stakeholders of TPM performance, highlighting issues, actions, and ongoing improvements to increase performance at TPMs that impact downstream operations.
- Represent Manufacturing as required with internal Brand Teams related to all aspects of the manufacturing process with specific TPMs.
- Through internal and external partnership build a performance improvement culture at TPMs and lead these identified programs to deliver bottom-line savings to AbbVie.
- Partner with Global Purchasing to negotiate Manufacturing Service Agreements (MSA's) and amendments and assure compliance with the terms of the agreements.
- Ensure effective planning and material procurement strategies are in place to supply TPM's and internal manufacturing operations with required materials.
- Assure global logistics and REACH registrations are in place to support all phases of the manufacturing contracts or purchase orders in alignment with Purchasing and Supplier quality expectations.
- With Global Purchasing contribute to the development of Financial Operating Plan, Updates, LRP, and Standard processes to ensure assure the financial goals are met.
- In coordination with Global Supply Chain, assure the TPM deliver the product according to the demand forecasted.
- Communicate to the TPM all aspects of the product agreement including product forecasts, manufacturing and delivery schedules.
- In partnership with QA ensure that manufacturing deviations and challenges are properly investigated and product disposition decisions are made in a timely manner by ensuring on-site presence where necessary. Ensure TPMs have the required quality systems and documentation to meet regulatory requirements, follow up inspection responses and commitments. Coordinate with QA, the annual quality management review, QTA's and periodic audits of the TPM.
- Ensure all manufacturing process changes are technically evaluated to ensure continued product quality
- Along with Science and Technology team ensure all processing/technical investigations are completed in a timely fashion.
- Bachelor's Degree required in a science/engineering discipline with further technical and/or business qualification strongly preferred.
- 10+ years' experience: operational and/or technical expertise in API, ADC or drug product manufacturing in a GMP Pharmaceutical environment. Previous account, program or technical transfer management expertise is a must. Proven relationship management and influencing skills a must.
- Previous experience of continuous improvement or operational excellence an advantage.
- Business acumen coupled with functional leadership experience is required to ensure effectiveness and high performance in a complex operation.