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Thermo Fisher Scientific Quality Control Head in Lexington, Massachusetts

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

Location/Division Specific Information

Lexington, MA - VVS

How will you make an impact?

Director Quality Control will provide strategic, technical, and operational leadership for QC-related activities. The QC Director will oversee methods transfer, feasibility, assessment, qualification/validation, as well as specification setting, product testing, and facility testing support.

What will you do?

  • Support VVS network by providing scientific leadership in resolving complex analytical challenges

  • Work directly with internal/external/client laboratories to carry out analytical development and validation activities to enable release and stability testing, including review and approval of method transfer/validation protocols, data analysis, and reports Oversight of analytical QC testing laboratories

  • Establish specifications to support global clinical trial/commercial material manufacture and release for both drug substance and drug product

  • Oversight of cGMP QC-related activities and documents (change controls, deviations, CAPAs, procedures, QC raw data review, batch release support, stability protocols and programs, validation protocols, etc.)

  • Oversee Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate

  • Oversee and support critical quality attributes, setting of specifications, data trending on stability and shelf life and expiry dating of DS and DP Author QC sections of regulatory filings and provide technical support for responses to Health Authority comments

  • Work with the Technical Operations team and with CMO personnel

  • Plan a sustainable cGMP QC platform to support a varied portfolio of Client cell therapy products. This includes ensuring a harmonized approach to method development and transfer in partnership with Manufacturing Sciences and Technology (MS&T) that supports the transition and implementation of methods fit for GMP QC support.

  • Develop phase-appropriate QC capabilities, business processes, and procedures.

  • Support cGMP manufacture and supply of high-quality cell therapy products for Clients, including oversight of cGMP sample handling, testing, QC release and stability data analyses, facility testing, method data trending, out of specification investigations, and Certificates of Analysis

  • Select and oversee contract QC laboratories including technical due diligence, routine performance management, and audits to ensure sustained quality analytical deliverables.

  • Member of the Quality Leadership Team (QLT). Contribute to Site goals and manage budgets and personnel.

  • Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the QC function remains in compliance with applicable company requirements and global regulations. Strategize and provide oversight of activities for transfer and qualification/validation of QC test methods from clients. Participates in Client project teams. Maintains good relations and communications with Clients as a primary technical interface for QC with the client's technical staff

  • Select, develop, manage and evaluate direct reports to ensure site objectives are met.

  • Lead QC activities for facility monitoring, release of raw materials (as needed) and products testing.

  • Provide expertise for QC related and QC impacting deviations, CAPAs and change controls.

How will you get here?

Education

  • PhD in Analytical Biochemistry or Biochemistry or related discipline with - required.

Experience

  • 10+ years of relevant experience in a QC position within the biological and/or pharmaceutical industry - required.

  • 5+ years in a management/leadership role - required.

  • Expertise and experience in all aspects of QC including analytical development, method validation, technology transfer, specification establishment, and stability program administration for protein-based therapeutics

Knowledge, Skills, Abilities

  • Ideal candidate has experience with regulatory interactions (FDA or EMA) including telecons and/or regulatory filings

  • Extensive experience in microbiological methods and contamination control

  • Ability to apply GMP regulations and international guidelines to all aspects of the position

  • Exceptional oral and written communication skills to all organization levels as well as clients and vendors

  • Experience with regulatory inspections and Client audits strongly preferred

  • Strong interpersonal and communication skill set to effectively work with internal and external stakeholders

  • In-depth technical and regulatory understanding of biologics, gene, or cell therapy QC with an understanding of the control strategy for these drug classes

  • Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables

  • Strong collaboration, team-building, and organizational skills; proven ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stakeholders.

  • Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, and excellent interpersonal, organizational, and written and oral communication skills.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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