Usp Expert R&d and Gmp - Gosselies, België - Thermo Fisher Scientific

Thermo Fisher Scientific

Geverifieerd bedrijf

Gosselies, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Mission

Key responsibilities:
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 uptodate 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, shelflife definition, cleaning strategy, reuse 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.

Education and skills

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 crossboundaries.
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.