AbbVie GMP Analytical Chemistry Manager in Lake County, Illinois
As part of the Operations Science and Technology organization the Section Manager will be responsible for the leadership and development of a team of scientists who provide technical support for transfer analytical methodologies from R&D to manufacturing and global governmental laboratories. The ideal candidate will have experience with late stage pharmaceutical product development and with troubleshooting and remediating analytical issues. Additional expertise in analytical method development (both practice and theory) and global validation requirements is preferred. This position requires a balance of scientific, logistic, and communication skills to achieve success. The role will be based out of the North Chicago facility.
Key Responsibilities Include :
- The Section Manager has technical and supervisory responsibility for the development, validation and transfer of analytical test methods, preparation of regulatory submissions and submission responses and troubleshooting/continuous improvement efforts associated with commercial testing laboratories.
- The Section Manager represents the MS&T organization to cross functional teams including R&D, Quality Assurance/Control, Manufacturing, Regulatory Affairs, Supply Chain and Third Party associates.
- Primary functions also include project resource estimation and management and technical support to non-GPO manufacturing affiliates and Third Party Manufacturers (TPM's).
- Definition, management and implementation of technical projects, including providing direction to the project team, and management of the team members.
- Provide technical expertise for process and product characterization during the development of new products, technical support to commercial product testing and manage/support investigations during development and commercial manufacturing.
- Critically evaluate and/or recommend specifications based on analytical data and method capability.
- Establish and manage goals that are consistent with the department, development, manufacturing and customer requirements.
- Advance the technical capabilities of the department by evaluating, recommending and implementing new technologies to meet business needs.
- Develop staff members in support of strategic business needs and personal development goals.
- Foster innovation in both technical development/problem solving and business processes.
- Ensure consistency of work practices with regulatory, cGMP and EHS requirements.
- The Section Manager position 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.
- The position requires interaction with scientists from various sites and at times frequent traveling to support the projects.
Basic: * BSc degree in a scientific or technical field typically 14 years of experience; MS or equivalent education with typically 12 years of experience; PhD with typically 6 years of experience. * Demonstrated ability to function as a principle investigator, generating original technical ideas and development strategies. * Demonstrated creative thinking to solve difficult technical problems and champion new technologies to achieve project goals. * Demonstrated scientific communication and presentation skills. * Exhibits a thorough understanding of Global CMC drug development, strong management skills, financial & research management practices and long term planning skills. * Must display managerial ability via leadership, supervisory experience and administration. * Experience in support of marketed products is preferred.
Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Illinois-Lake County
Travel: Yes, 10 % of the Time
Req ID: 1605966
Equal Opportunity Employer Minorities/Women/Veterans/Disabled