The Director, Global Technical Services - Respiratory is responsible for leading technical aspects of externally manufactured products for the Respiratory portfolio and selected global key brands. This includes developing and executing tech transfer projects in alignment with projected commercial launch targets; improving robustness and efficiency of manufacturing processes resulting in optimal right first time (7FT8) and cost competitiveness; providing and developing technical expertise to support the overall performance of vendors; meeting or exceeding safety, quality, customer service and cost targets. This will be performed in close partnership with Viatris Respiratory Research and Development, Manufacturing, Quality, Sourcing and other departments as required to manage third party manufacturing in a holistic approach.
Key responsibilities for this role include:
For assigned products, partner with Respiratory R&D, Manufacturing, Quality, Supply Chain, Sourcing and other departments as needed to support holistic management of contract manufacturing capability and reliability. This includes technical and project leadership for assigned products.
Be the technical point of contact for the Contract Manufacturing Organization (CMO) including evaluation of technical performance and capacity against commercial demand.
Demonstrate competence in negotiation and influencing skills as related to CMO/vendor/project management and further be able to effectively manage conflict and communicate recommendations/mitigations to senior management.
Independently manage CMOs/vendors to agreed project timelines, ensuring alignment with internal project teams. Ensure all stakeholders remain on track to deliver projects within the agreed budget and timeframe resulting in a quality process and product. Further, demonstrate the ability to use risk management tools to describe changes/mitigations for delivery of a successful project.
Develop and execute tech transfer project plans in collaboration with Respiratory R&D. Provide the interface support between Process Development and Manufacturing Operations to ensure effective implementation of new processes/technologies into GMP manufacturing operation.
Lead support for GMP manufacturing Operations external to Viatris by leading investigations and determination of Root Cause. Drive CAPA closure where appropriate. Support topics include, but are not limited to, production process, QC testing, stability results, and raw materials.
Identify opportunities to improve quality, safety, productivity and reliability of manufacturing processes, including the introduction of new technology. Using sound science and optimal technology, translate opportunities into a business case inclusive of budget, time and risk/mitigation profile with a focus of improving quality and cost.
Act as an SME in your field to support other members of the technical services team and where required develop technical proficiency of Viatris colleagues through sharing product/process knowledge.
Drive the continuous improvement of the companys existing technologies while also supporting the development of new technological and/or product innovations and introduction in partnership with Quality, External Supply Operations, and R&D.
The minimum qualifications for this role are:
Minimum of a Bachelors Degree (or equivalent) with a specialization in Engineering or a related science field is required, with relevant experience. Related experience and/or education may be considered.
Must be knowledgeable in pharmaceutical development and GMP manufacturing, preferably for respiratory products.
Experience required in at least one of the following product categories: OINDP, parenteral, blow-fill-seal, vaccine, or drug/device combinations.
Must possess the ability to plan, coordinate, and execute experimental plans, especially in commercial plants.
Experience of statistical analysis and reporting of results to both technical and senior leader stakeholders.
The ability to build, lead, and technically manage matrix teams responsible for the delivery of complex products.
Clear demonstration of leader behaviors including influencing, negotiation, conflict management and stakeholder/senior leader management.
Excellent communication skills in written and spoken format.
This remote role has flexibility to be based in the UK, Europe or the United States.
Proficiency in speaking, comprehending, reading and writing English is required.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $112,000.00 - $236,000.00 USD.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.