![Argenx](https://media.trabajo.org/img/noimg.jpg)
Senior Scientist Cmc
il y a 4 semaines
1. PURPOSE OF THE FUNCTION
A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget. He/she drives internal and external efforts with the aim of developing, producing and characterizing these differentiated antibody therapeutics and is responsible for technical mastery of scientific and technical documents as well as follow‐up on CMC project progress. The CMC Senior Scientist utilizes his expertise to resolve obstacles and by bringing creative solutions to the table.
2. REPORTING LINE
Report to Director CMC DP
3. ROLES AND RESPONSIBILITIES
- Facilitate the establishment of integrated CMC operational plans with external
service providers by providing expert input, problem resolution definition and
priority setting and oversee their execution within agreed timelines, scope and
budget; external service providers include drug product manufacturing, pack &
labelling and analytical testing services;
- Leads drug product site transfer and scale-up activities;
- Critical quality/technical review of CMC documents (e.g. process development protocols/reports, validation protocols/reports, stability protocols/reports, etc.) and batch manufacturing records with mínimal guidance and able to draw appropriate conclusions;
- As a member of the CMC team actively contribute to technical and strategic CMC discussions;
- Identify and track project critical path items ‐ identify risks, formulate and monitor corrective actions;
- Support development and execution of supply strategies for clinical studies;
- Develop SOPs effectively describing CMC processes;
- Liaise with quality assurance on quality related matters
4. SKILLS AND COMPETENCIES
- Thorough knowledge and experience with GMP
- Works independently within the scope of his assigned field and supports others
- Keep abreast with relevant scientific and/or technical developments. Searches literature and other sources independently and applies knowledge.
- Excellent organizational and coordination skills
- Ability to go into detail whilst keeping the view on the overall project goal;
- Strong technical expertise combined with good project management skills and ability to communicate effectively with internal and external stakeholders;
- Flexible attitude, capable of picking up the tasks that require attention;
- Quality conscious attitude;
- Experience and knowledge in the preparation of regulatory submissions;
- In depth knowledge of ICH and GMP regulations;
- Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines;
5. EDUCATION, EXPERIENCE AND QUALIFICATIONS
- PhD in chemistry, pharmaceutical sciences, bio‐engineering, or other discipline within
pharmaceutical / biotechnology sciences;
- Strong technical expertise in the field of biological drug substance and drug product
manufacturing, process characterisation and process validation; good understanding
of statistics;
- Expected experience: 2-5y within relevant industry
- Fluent in English, written and spoke
**Offer**:
- A competitive salary package with extensive benefits
- Front seat in the development of therapeutic antibodies
- A work environment in a human-sized, dynamic and rapidly growing biotech company
- Possibility to work remotely with limited travelling required
LI-Onsite
-
Cmc Scientist
il y a 3 semaines
Gent, Belgique Argenx Temps pleinTo further strengthen our CMC team, we are looking for an experienced and motivated CMC scientist/ senior Scientist. The scientist/ senior scientist CMC will play a lead role supporting cell line development, drug substance (DS) manufacturing process development and analytical method development with external manufacturing partners (CMOs) to enable clinical...
-
Senior Scientist Cmc
il y a 2 semaines
Gent, Belgique MindCapture Temps pleinSENIOR SCIENTIST CMC - Biotechnology- GhentWHAT IS OFFERED - Competitive salary package with extensive benefits. - Opportunity to contribute to the development of therapeutic antibodies and make a tangible impact on patient care. - Dynamic work environment within a rapidly growing biotech company. - Collaborative culture that fosters creativity, innovation...
-
Principal Scientist Cmc Analytical Development
il y a 2 semaines
Gent, Belgique Argenx Temps pleinTo further strengthen our CMC team, we are looking for a Principal Scientist CMC Analytical Development. The Principal Scientist CMC occupies a key role supporting Chemistry, Manufacturing and Controls (CMC) development for argenx therapeutic antibodies, ensuring that projects successfully move forward within and across functions. He/she drives internal and...
-
Cmc Scientist Early Drug Development
il y a 4 semaines
Gent, Belgique Argenx Temps pleinTo further strengthen our CMC team, we are looking for a motivated CMC Scientist Early Drug Development. The will work in close concert with internal research teams as well as external development parties. The CMC Scientist challenges. *Key Accountabilities and Responsibilities: - * - Early stage formulation development; - Early stage productivity...
-
Associate Cmc Regulatory Scientist
il y a 3 jours
Gent, Belgique Ardena Temps plein**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...
-
(Associate) Scientist Cmc
il y a 4 semaines
Gent, Belgique Argenx Temps pleinPurpose of the function (Associate) Scientist CMC occupies a supporting role in Chemistry, Manufacturing and Controls (CMC) team for argenx therapeutic antibodies and their life cycle management following commercialization. Reporting Line Director CMC, analytical development Roles and Responsabilities - Follow up on the execution of agreed commercial...
-
Junior Associate Scientist
il y a 18 heures
Gent, Belgique Sanofi Temps pleinJunior Associate Scientist - CMC Analytics - BioPhysical Profiling_ - Location: Ghent, BE - This is a Lab based role with possibility of working 2 days/month from home - Job type: 12 months fixed-term contract, full time - About the job_ Join Sanofi R&D site in Ghent as Junior Associate Scientist - CMC Analytics - BioPhysical Profiling team. In this role...
-
Associate Cmc Regulatory Scientist
il y a 3 semaines
Gent, Belgique Ardena Temps plein**About us** **Ardena **is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...
-
Scientist Cmc Dossier Development
il y a 2 semaines
Gent, Belgique Argenx Temps pleinsevere auto‐immune diseases. Report to: Head of Dossier Development Key Accountabilities and Responsibilities: Contributes to the CMC development of pre‐clinical, clinical and commercial stage programs in close collaboration with the CMC team members by: - Participate to the authoring and preparing IND, IMPD, scientific briefing documents,...
-
Administrative Associate Scientist Cmc
il y a 2 semaines
Gent, Belgique Sanofi Temps plein**About the Opportunity** As an Administrative Associate Scientist in the CMC Pharmaceutical Development & Technology (PD&T) Department, you will act as a centralised service provider and will be responsible for providing administrative support to the entire CMC PD&T department You will be part of the team responsible for the in-depth analysis of the...
-
(Senior) Scientist Cmc Analytical Development
il y a 3 semaines
Gent, Belgique Argenx Temps pleinKey Accountabilities and Responsibilities: Contributes to the CMC development of pre‐clinical and clinical stage development programs in close collaboration with the CMC team members by: - Drives the development and validation of analytical test methods for large molecules release and stability testing in accordance with the applicable regulatory...
-
Scientist Cmc Analytical Development
il y a 2 semaines
Gent, Belgique Argenx Temps pleinReport to: Analytical Development Lead Key Accountabilities and Responsibilities: Contributes to the CMC development of pre‐clinical and clinical stage development programs in close collaboration with the CMC team members by: - Drives the development and validation of analytical test methods for large molecules release and stability testing in accordance...
-
Senior Biostatistics Scientist
il y a 3 semaines
Gent, Belgique BioLizard Temps pleinWho we are BioLizard is a consultancy company providing bioinformatics, data science and data management solutions for our customers in biotech, pharma and diagnostics. Typically, a lizard adjusts to its surroundings. That is exactly what we do, we adapt to our customers’ data environment! The research field is rapidly becoming more data-driven, where we...
-
Senior Pk/pd Scientist/modeler
il y a 2 semaines
Gent, Belgique Argenx Temps pleinThe argenx Quantitative Pharmacology and Pharmacometrics group (QCP²) looks for an experienced PK/PD scientist/modeler to support multiple aspects during pre-clinical drug development. We envision that the experienced PK/PD scientist/modeler will guide us in the pre-clinical development strategy of projects, ensuring a high quality data package supportive...
-
(Senior) Scientist Antibody Discovery
il y a 4 semaines
Gent, Belgique Exevir Bio Temps plein**WE ARE HIRING **(Senior) Scientist Antibody Discovery **THE COMPANY** ExeVir develops single-domain antibody-based therapies that help patients ward off viral infections. COVID-19 is an unprecedented global threat, which requires a rapid response due to its tremendous impact on patients, health care systems, societies and economies. The client aims to...
-
Senior Scientist Msat Advanced Therapies
il y a 4 semaines
Gent, Belgique Johnson & Johnson Temps pleinJohnson and Johnson is recruiting for a **Manufacturing Science and Technology **(MSAT) **Senior Scientist, **located in **Gent, Belgium **. The Senior Scientist we are looking for is responsible the coordination of tech transfer activities and technical services across the platform of the Advanced Therapies. In this role you are charged with running New...
-
Senior Scientist Bioanalytical
il y a 3 semaines
Gent, Belgique Argenx Temps pleinFor the expansion of our Bioanalytical team, argenx seeks a highly motivated Senior Scientist in Bioanalytics with specialized expertise in immunogenicity assay development/validation for large molecules and/or clinical immunogenicity risk assessment and data interpretation. The Senior Scientist will spearhead the implementation of bioanalytical and...
-
Senior Scientist Bioanalytics
il y a 3 semaines
Gent, Belgique Argenx Temps pleinOperating under an outsourced model, argenx collaborates with bioanalytical vendors. The Senior Scientist will serve as the representative of the Bioanalytical team within one or multiple project teams, fostering close collaboration with internal and external stakeholders. Responsibilities include implementing bioanalytical strategies and contributing to...
-
(Senior) Scientist Parenterals
il y a 2 semaines
Gent, Belgique Ardena Temps plein**About us** **Ardena **is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...
-
Senior Scientist Purification/downstream Processing
il y a 2 semaines
Gent, Belgique Eurofins Belgium BioPharma Services Temps pleinCompany Description **Eurofins CDMO** is a leading international Contract Development and Manufacturing Organization (CDMO) based in Europe. Our company focuses on drug product development for chemical/biological entities and drug substance development for biologics. We support small and major biopharmaceutical companies in an innovative way to help them...