![Thermo Fisher Scientific](https://media.trabajo.org/img/noimg.jpg)
Usp Expert R&d and Gmp
Il y a 2 mois
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 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.
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 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.
-
Gmp Support Manager
il y a 2 semaines
Gosselies, Belgique Catalent Temps plein**Position Summary** Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services,...
-
Gmp Support Manager
il y a 1 semaine
Gosselies, Wallonie, Belgique Catalent Temps plein**Position Summary**Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services,...
-
Cmc Drug Product Leader
il y a 4 semaines
Gosselies, Belgique iTeos Therapeutics Temps plein**ABOUT ITEOS THERAPEUTICS, INC** iTeos Therapeutics is a publicly-traded (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies. Based in Gosselies, Belgium and Watertown, MA, iTeos Therapeutics was founded out of the Ludwig...
-
Cmc Drug Product Leader
il y a 1 heure
Gosselies, Belgique iTeos Therapeutics Temps plein**ABOUT ITEOS THERAPEUTICS, INC** iTeos Therapeutics is a publicly-traded (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies. Based in Gosselies, Belgium and Watertown, MA, iTeos Therapeutics was founded out of the Ludwig...
-
Cmc Drug Product Leader
il y a 1 semaine
Gosselies, Wallonie, Belgique iTeos Therapeutics Temps pleinABOUT ITEOS THERAPEUTICS, INCiTeos Therapeutics is a publicly-traded (NASDAQ:ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies.Based in Gosselies, Belgium and Watertown, MA, iTeos Therapeutics was founded out of the Ludwig...
-
Data Integrity Sr Leader
il y a 2 semaines
Gosselies, Belgique Catalent Temps plein**Position Summary** Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organization, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services,...
-
Data Integrity Sr Leader
il y a 1 semaine
Gosselies, Wallonie, Belgique Catalent Temps pleinPosition SummaryBased in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organization, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent's...
-
HR Payroll
il y a 3 semaines
Gosselies, Belgique Catalent Temps pleinBased in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are...
-
QA Validation Csv Lead
il y a 2 semaines
Gosselies, Belgique Catalent Temps pleinBased in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are...
-
BPMn Expert
Il y a 2 mois
Gosselies, Belgique ATCON GLOBAL Temps pleinFor one of our clients in Belgium, we are looking for a **BPMN Expert** to join our Team. **Location**: Gosselies **Languages**: French and Enlish **Employment Type**: Permanent or Freelance **Start Date**: ASAP **Context of the Mission**: Looking for a Business Analyst/BPMN Expert to model business processes as part of business transformation...
-
R&d Analytical Development
il y a 1 semaine
Gosselies, Wallonie, Belgique Thermo Fisher Scientific Temps pleinCe type d'installation doit se conformer aux règles et réglementations des BPF établies par les ministères de la santé et de la protection sociale des pays, ainsi qu'aux directives internationales.Pour renforcer nos activités R&D de développement analytique basées sur le site de Gosselies, Belgique, nous sommes à la recherche d'un profil de **Method...
-
QA Engineering Manager
Il y a 2 mois
Gosselies, Belgique Catalent Temps pleinBased in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are...
-
QA Validation Manager
il y a 2 semaines
Gosselies, Belgique Catalent Temps pleinBased in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are...
-
BPMn Expert
il y a 1 semaine
Gosselies, Wallonie, Belgique ATCON GLOBAL Temps pleinFor one of our clients in Belgium, we are looking for a BPMN Expert to join our Team.Location: GosseliesLanguages: French and EnlishEmployment Type: Permanent or FreelanceStart Date:ASAPContext of the Mission:Looking for a Business Analyst/BPMN Expert to model business processes as part of business transformation projects. This expert will be part of a...
-
Expert BPMn
il y a 3 semaines
Gosselies, Belgique ATCON GLOBAL Temps plein**Location**:Gosselies(1 day/week onsite) **Languages**: French **Employment Type**: Freelance **Start Date**: ASAP **Context of the mission / Objective(s) of the job** Looking for a Business Analyst/BPMN Expert, in order to model business processes as part of the company's transformation projects. This expert will be part of a centralized unit already in...
-
BPMn Expert
il y a 1 semaine
Gosselies, Wallonie, Belgique Pauwels Consulting Temps pleinWe are currently looking for a new member to strengthen our team of BPMN experts in the Hainaut region. Are you currently looking for a new project or professional challenge where your BPMN expertise will prove to be an important asset? Then it might be a good idea to keep on reading...Because at Pauwels Consulting, we don't just mix and match our...
-
Senior Scientist, Immunology Ipsc-based Cell
il y a 3 semaines
Gosselies, Belgique BioTalent Temps plein**Sr. Scientist - Immunology Cell Therapy**: **Introduction** This Senior Scientist in Immunology opportunity is with a pioneering company developing scalable allogenic manufacture based on iPSC technology. With the benefit of providing low cost, off the shelf to significantly improve patient outcomes. They are located in Belgium and are undergoing a period...
-
Senior Scientist, Immunology Ipsc-based Cell Therapy
il y a 2 semaines
Gosselies, Belgique BioTalent Temps plein**Sr. Scientist - Immunology**: **Introduction** This Senior Scientist in Immunology opportunity is with a pioneering company developing scalable allogenic manufacture based on iPSC technology. With the benefit of providing low cost, off the shelf to significantly improve patient outcomes. They are located in Belgium and are undergoing a period of expansion...
-
R&d Analytical Development
Il y a 2 mois
Gosselies, Belgique Thermo Fisher Scientific Temps pleinCe type d'installation doit se conformer aux règles et réglementations des BPF établies par les ministères de la santé et de la protection sociale des pays, ainsi qu'aux directives internationales. Pour renforcer nos activités R&D de développement analytique basées sur le site de Gosselies, Belgique, nous sommes à la recherche d’un profil de...
-
R&d Analytical Development
il y a 21 heures
Gosselies, Belgique Thermo Fisher Scientific Temps pleinCe type d'installation doit se conformer aux règles et réglementations des BPF établies par les ministères de la santé et de la protection sociale des pays, ainsi qu'aux directives internationales. Pour renforcer nos activités R&D de développement analytique basées sur le site de Gosselies, Belgique, nous sommes à la recherche d’un profil de...