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USP Expert R&D and GMP (H/F/X)

July 24th 2023

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $45 billion. Our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies, or growing efficiency in their laboratories, we are here to support them. Our distributed team of more than 100,000 colleagues delivers an outstanding 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.

Mission Description

  • The USP (UpStream Process) Manufacturing Lead acts as a transversal subject matter expert in USP processes to enable robust manufacturing capabilities from R&D to GMP.

Strategic:

  • Enable the design and implementation of robust and scalable manufacturing process in line with customers and regulatory authorities’ expectations.
  • Raise technical excellence and innovation within the department.
  • Participate in ensuring department goals and metrics meet or exceed expectations.
  • Identify initiatives and investments with significant impact on department objectives.

Operational:

  • Closely collaborate with (senior) scientists within the team to drive the design and implementation of robust and scalable manufacturing process from development to commercialization.
  • Interact with DSP (DownStream Process) & AD (Analytical Development) to ensure holistic approach.
  • Maintain up-to-date knowledge of viral vectors manufacturing and provide recommendation regarding process innovation and improvement, data management solutions, new equipment and raw materials.
  • Perform review of process flow, footprint, batch records, process data (parameters and outputs). Identify potential risks or trends and recommend process improvements or mitigation plans when needed.
  • Provide technical expertise for process readiness and risks assessments including: Facility Fit Gap Assessments (FFGA), critical process parameters and raw materials Risk Assessment, Failure Mode and Effects Analysis (FMEA).
  • Provide technical expertise to design supportive studies such hold times definition, stability testing, shelf-life definition, cleaning strategy, re-use and lifetime definition, bacterial challenge test, media fill test, container integrity test, mixing and homogeneity, extractible & leachable, viral clearance.
  • Support deviation investigations, identify relevant Corrective and/or Prevention Actions (CAPAs), and Change Controls when applicable.
  • Ensure harmonization of manufacturing solutions (incl. assemblies, buffers) from R&D to GMP,
  • Provide technical support to business team in their interactions with customers among which: design of scope of work, timelines and costs definition.
  • Act as a coach with junior people and participate in developing technical skills across the department.
  • Adhere to Quality standards, cGMP requirements and EHS practices.

Candidate profile

  • Master/Ph D degree in a life sciences or Chemical Engineering discipline and a minimum of 6 years of relevant experience in Process development, transfer, characterization, validation and life cycle management for biologics, vaccines or cell/gene therapy.
  • Knowledge in biostatistics and analytical methods
  • Strong leadership skills and ability to work cross-boundaries.
  • Excellent written and verbal communication skills at all levels in the organization.
  • Language skills: French and English
  • Promote a productive and cooperative climate by engaging in a trusting, supportive partnership with others, and solve conflicts in a constructive manner that allows win/win solution.

Offer

USP Expert R&D and GMP

Contact Details

https://jobs.thermofisher.com/global/en/job/R-01185584/USP-Expert-R-D-and-GMP