Emergent BioSolutions is committed to assisting employees achieve their professional goals. Internal job postings are one of the tools available to employees at Emergent BioSolutions to assist in their career management. This enables current employees who have remained in their current position for a minimum of one year to apply for an open position.

The QC Director provides strong leadership, strategic planning, and laboratory system oversight for Emergent Biosolutions Operations in Canton MA. 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 Product Release, Microbiology/Sterility Assurance, Stability, and Raw Material groups.

Responsibilites

• Provide effective strong leadership 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 all aspects of laboratory functions including the testing of raw materials, in process materials/components, drug substance/ drug products, stability samples and environmental monitoring.
• 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 equipment and the continual assessment of method capability through a Quality by Design framework.
• 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 Emergentxpectations for cost and delivery.
• Serve as an SME for analytical methodologies, specifications, stability studies, and reference standards for project teams and employee skill development.
• Author or approve QC sections of relevant regulatory submissions and product quality reviews
• Oversees laboratory investigations and excursions, change controls, and Deviation/CAPA systems for QC operations.
• 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.

Education, Experience & Skills

Educational Requirement: BS in Analytical, Biochemistry, Microbiology, or other closely related scientific field. PhD preferred.

At least 10 yearsperience in Management in 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 applied statistics.

Experience in FDA, corporate and third party audits

Strong managerial skills coupled with self-awareness, empathy, relationship management are essential.

Strong technical knowledge in Chemical, Biochemical, and Microbiological theory and methods such as HPLC, GC, SDS-PAGE, PCR, TOC, Protein Analysis (ELISA), Animal-Based and Cell-Based Bioassays, and Sterility testing.

Understanding of Analytical method development and Method transfers and comendial testing.

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.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

"UNDER MARYLAND LAW, AN EMPLOYER MAY NO REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT INDIVIDUALS SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILIAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100."

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutionsproved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutionsproved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.