The Associate Director position within the Sciences and Technology (S&T) organization is responsible for providing technical leadership, direction and management of the S&T Parenterals 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.
- Provides technical leadership for multiple Parenteral projects and is responsible for financial planning, resource allocation, and timeline estimates of the project as well as its execution.
- Responsible for implementation of global products across AbbVie plants and marketed affiliates, inclusive of both AbbVie plants and Third Party Manufacturers (TPMs) as required by the demands of Global manufacturing and product sourcing strategies.
- Provides technical expertise in parenterals and sterile manufacture for marketed products and can represent the company in discussions with regulatory agencies. Due to the nature of the projects and support of marketed products, the impact of decisions is significant to AbbVie's pharmaceutical Operations as it relates to minimizing back orders and regulatory risks.
- The parenteral function is responsible for providing analytical and process support for transfer of new chemical entities from R&D to various manufacturing plants and transfer of marketed products between manufacturing plants and TPMs as well as process improvements and CMC regulatory support of marketed products.
- Leads a parenteral 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 authorities 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.
- Interacts 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 S&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 parenteral processes and ensuring that customer services and customer support remain uninterrupted.
- Manages 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.
- 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.
- Managerial experience via matrix team leadership and/or supervisory experience.
- Exhibits a thorough understanding of Global CMC drug development and long term planning skills.
- Extensive knowledge of various international Quality (cGMP) and Regulatory requirements including authoring and approving for regulatory submissions.
- Must be goal oriented, able to work within a team environment, self-motivated and understand the business needs to meet timelines.
- Strong verbal and written communication skills necessary to interface with multiple functions within the global organization.
- Previous related work experience in large molecule and parenteral formulation development or commercial product support. Expertise in lyophilization, sterile filling, and terminal sterilization processes strongly preferred.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
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