Thermo Fisher Scientific Job - 39229143 | CareerArc
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Company: Thermo Fisher Scientific
Location: Cambridge, MA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

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.

How will you make an impact?

The Head of QC - Assay Qualification provides leadership and technical expertise for the analytical method transfer and lab equipment qualification activities in the Cambridge site. These activities include the qualification/validation of analytical methods for support of cGMP compliant manufacturing and translation of assays from clients and internally from MST/ADA/FL QC to the cGMP QC testing laboratory. In additions, the qualification/validation of laboratory equipment to support cGMP compliant manufacturing and QC testing. The manager handle communications with clients as a primary technical interface between the client's technical staff.

What will you do?

  • The manager is also responsible for maintaining cGMP compliance in his/her areas of responsibility and for operating within project and department budgets. The manager is responsible for direct supervisor of QC scientists and technicians, and is responsible for hiring, training, goal setting and performance evaluation. The manager will work closely with all departments and the appropriate project teams to assist in project planning and timeline development.
  • The incumbent will plan, implement, and coordinate the improvement of QC analytical services, considering the application of up-to-date technical, GMP and quality principles and ensuring safe environmental and working conditions in the QC Laboratories. The manager attracts, facilitates, participates in contract development and maintains good relations and ensures robust communication with clients on programmatic and technical aspects.
  • Strives to improve systems and drive efficiency throughout the organization. Supports internal, external and regulatory inspections as needed. Manages team of managers and professionals within Quality. Hires and develops employees within the department. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.
  • Serves as primary QC Validation contact for regulatory inspections and client audits.
  • Manage QC staff members to ensure implementation of new analytical methods in the GMP environment, including phase appropriate qualification/validation of methods.
  • Responsible for method transfer from clients and internal sites, and to contract test labs, method comparability, and training of analysts.
  • Responsible for qualification and maintenance of new and existing laboratory equipment.
  • Develop appropriate metrics as required by the Quality System.
  • Ensures the readiness of the QC Validation team for all external and internal audits/inspections, participates in audits/inspections and ensures on time completion of all audit/inspection commitments.
  • Develop, revise and review SOPs, test methods, qualification/validation protocols and reports.
  • Provide oversight of method qualification and validation.
  • Analyzes regulatory authorities' programs, guidance documents and activities in areas relevant to testing of biological products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
  • Evaluates the functional strengths and developmental areas in the QC analytical organization and focuses on continuous improvement, including participating in the evaluation and introduction of new analytical technologies in ADA and MST

How will you get here?

Education & Experience

  • PhD molecular biologist or biochemist with 5-7 years of Quality Control experience or MS (required) with 10 – 12 years of Quality Control experience in the biotech and/or pharmaceutical industry
  • Minimum 4 years of QC lab management experience in the biotech and/or pharmaceutical industry,
  • Prior experience in external regulatory inspections (e.g. FDA, MHRA)

Knowledge, Skills & Abilities

  • The ideal candidate will be well versed in Molecular, Viral, Cell and Tissue Culture operations and principles. Has a good understanding and is capable of managing Contract testing and procedures
  • Working knowledge of quality systems and regulatory requirements
  • Minimum 4 years of QC lab management experience in the biotech and/or pharmaceutical industry,
  • Strong knowledge of GMP, SOPs and quality control processes

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.



To Apply, please click the following link: https://thermofisher.contacthr.com/82349349


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