Location
Worcester, MA | United States
Job description
The AbbVie Bioresearch Center (ABC) site is AbbVie’s center of excellence for biologics drug substance (BDS) manufacturing co-located with Research and Development in Worcester, MA. The ABC site delivers clinical, commercial and third-party BDS including monoclonal antibodies, therapeutic proteins and antibody drug conjugates in multiple manufacturing suites, scales, and technologies. The Quality Control laboratories are responsible for end-to-end testing encompassing raw materials, cell banks, buffers, media, product in-process, release and stability, environmental and utilities monitoring with the scope of this position to lead all microbiological, analytical laboratories and laboratory support functions.
- Manages QC business units including setting of vision and strategy, develop and manage operating budgets, management of large group of technical employees, project management, and unit operational management to support overall business operations.
- Provide technical leadership in a multidisciplinary environment to ensure activities are on track per business needs and established timeline. Serves as an expert in technical/functional areas..
- Direct management of the Lake County QC lab operation and provide product quality system leadership to business operations
- Establish and execute plans and commitments consistent to Development, Manufacturing, Customers and Business needs.
- Develop, negotiate, finalize timelines and cost estimates for projects and/or service contracts to support business operations and/or external customer’s needs.
- Applies extensive advanced scientific knowledge to design and manage multi-disciplinary projects.
- Applies advanced technical writing skills to prepare project protocol, and final reports to support product registration and/or business needs.
- Provides leadership in Product Quality Control Procedure and Quality System to support overall business operations. Responsible for site processes and procedures related to Quality Control laboratory to ensure product quality and compliance.
- Establishes and enforces product quality system procedure for business operations. Interface with multi-disciplinary functional areas including, development, operations, quality, compliance, and regulatory.
- Bachelor’s degree with 15+ years of Quality and/or Regulatory experience
- Prior experience managing a QC laboratory or other technical/scientific group
- Strong people leadership skills
- Solid understanding of financials and budgetary management experience
- Knowledge and understanding of operation of product quality control lab, product quality control requirement and system.
- Shows broad understanding of the issues relevant to the technical/science and business.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status.
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