Associate Director MSAT PDS&T at AbbVie · LumiJobs

Responsibilities

Provides technical leadership for multiple PDS&T projects and is responsible for financial planning, budget responsibility and timeline estimates of the project as well as execution.
Responsible for implementation of global projects across AbbVie plants and marketed affiliates this includes both AbbVie plants and products manufactured at Third Party Manufacturers (TPMs)
Provides technical expertise for marketed products and can represent the company in discussions with regulatory agencies. Due to nature of the projects and support of marketed products, the impacts of decisions are significant to AbbVie's pharmaceutical Operations ($1B) to minimize back orders and regulatory risks.
Each technical function is responsible for providing support for marketed products including those related to transfer of new chemical entities from R&D to various manufacturing plants as well as process improvement and CMC support of marketed products. The role also includes transfer of marketed products between manufacturing plants and TPMs as required by the demands of Global manufacturing and product sourcing strategies.
Leads the team that handles complex technical projects. These projects generally impact a significant portion of the business, are shared among multiple plants and/or markets. The team provides a high level of technical expertise required for support of various regulatory organizations and market needs and has a global approach in implementation of projects to ensure consistency. Teams within these functions have global responsibility (50+ markets), support multiple plants and/or markets.
The scope of activities for these teams includes interactions with R&D, Operations, Quality, Commercial and regulatory as well as the relevant technical plant support functions both within AbbVie and at third party manufacturers.
Works directly with multiple groups in a matrix approach to ensure that the overall objectives of the MS&T organization are met. These include the provision of seamless and effective technology transfers across AbbVie manufacturing facilities globally, the development of cost effective, robust and compliant processes and ensuring that customer services and customer support remain uninterrupted.
Management of a technical team of multiple scientists and technicians ranging from scientist to senior level scientists. The group is responsible for providing technical expertise for all regulatory and quality documentation as well as post approval filings.
The global nature of the job requires the position to have an excellent knowledge of various regulatory and GMP requirements as well as outstanding communication skills. The position requires interaction with scientists from various sites and at times frequent traveling to support the projects.
BSc degree in a scientific or technical field preferably in Life sciences, pharmacy or engineering required. Masters Degree and/or PhD is preferred.
Ten (10) + years in the Pharmaceutical Industry with at least 5 years working in relevant support group is required. Experience in support of marketed products is preferred.
The Technical Manager must display managerial ability via leadership, supervisory experience and administration.

Associate Director MSAT PDS&T

Responsibilities

Benefits

Company

AbbVie

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