Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I: Job Summary
The QC Director provides strong leadership, strategic planning, and laboratory system oversight for Emergent Biosolutions Operations in Baltimore, MD. The QC Director is responsible for the laboratory testing of raw materials, in-process samples, final products, and stability studies. The QC Director has oversight for the Analytical Chemistry, Protein Chemistry, Bioassay,Microbiology, Environmental Monitoring,, QC Support, and Stability functions.
- Provide effective leadership, subordinating personal and individual interests to the needs of the organization through a demonstration of character, humility, experience and judgment that promotes a culture of accountability and operational excellence.
- Ensure cGMP compliance in the testing of vaccines, raw materials, in process materials and other biological products, representing the company in contact with the FDA and other regulatory agencies and customers for QC-related matters.
- Provide strategic planning to the QC department through a lifecycle approach to instrumentation and the continual assessment of method capability through a Quality by Design framework.
- Represent the Voice of the Customer in method development, validation, and transfer activities. Collaborate with Analytical Development to ensure robust test transfer, development, and/or validation provide for a method that is fit for use.
- Oversee budget and resource allocation, deriving value from laboratory activities while maintaining alignment with site and corporate strategic objectives.
- Ensure that contracted third party tests are in compliance with appropriate quality standards and designed to meet Emergent’s expectations for cost and delivery.
- Serve as an SME for analytical methodologies, specifications, stability studies, deviation investigations, and reference standards for project teams and employee skill development.
- Author and/or approve QC sections of relevant regulatory submissions and product quality reviews including trend analyses and annual product review data analyses.
- Accountable for timely completion of QC laboratory investigations, change controls, and CAPAs.
- Serve as a member of site leadership, interacting with other functional areas and cross-functional teams to define and execute project requirements and objectives and maintain compliance across the site.
- Manage and mentor QC management staff, emphasizing teamwork, planning, follow-up and effective communication.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
Educational Requirement: BS in, Biochemistry, Microbiology, Chemical Engineering or other closely related scientific field. MS or PhD preferred.
At least 10 years’ experience in management for Vaccine, Biologics or Pharmaceutical testing facility.
Demonstrated track record of successful application and interpretation of FDA/ICH regulations, industry guidance, and pharmacopeial testing standards.
Must have a working knowledge of appliedstatistics.
Strong managerial skills coupled with self-awareness and empathy are essential.
Strong technical knowledge in Chemical, Biochemical, and Microbiological theory and methods such as HPLC, GC, SDS-PAGE, Protein Analysis, Animal-Based and Cell-Based Bioassays, and Sterility testing.
IV: Physical/Mental Requirements
Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, reach outward, reach above shoulder, hand dexterity, bend, squat/keel, sense of feel, sense of hearing, sense of smell, lift carry 10lbs, push/pull 10lb. Use phone, fax, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Work around noise above conversation level, multiple locations, restricted access laboratory, and contact with select agents.