Associate Director MSAT PDS&T

About the role

The Associate Director, Technical position within the Product, Development, Sciences and Technology (PDS&T) organization is responsible for providing technical leadership, direction and management of the PDS&T teams. The manager will provide technical expertise for commercial manufacturing during development of new products, manage operation and commercial timelines, and executes budgets for global projects and the team.

The Technical Manager establishes goals that are consistent with the department, development, manufacturing and customer requirements, implements plans and policies, assigns duties and responsibilities and controls subordinates performance to meet the goals and commitments.

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.

Qualifications & Requirements

• 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.
• Exhibits a thorough understanding of Global CMC drug development, strong management skills, financial & research management practices and long term planning skills.
• Excellent knowledge of various international regulatory and GMP requirements.
• Must be goal oriented, able to work within a team environment, self-motivated and understand the business needs to meet timelines.
• Good verbal, written communication skills and the ability to interface with multiple areas within the organization is essential.
• Previous related work experience in formulation/process and/or analytical service groups is preferred
• Previous experience in supervising people is preferred.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.