Senior Scientist physico-chemical analytics-00000MQL
Description
Crucell is a global biotech company that focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
Within Crucell talented, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Crucell.
For our Bacterial Vaccines department we are currently seeking for a fulltime
Senior Scientist physico-chemical analytics (m/f)
Department/Project:
The Bacterial Vaccines department is working on the discovery and early development of novel vaccines for bacterial infectious diseases. It strives to address unmet medical needs, such as bacteremia (sepsis), meningitis, and respiratory tract and nosocomial infections. Projects at the Bacterial Vaccines department are primarily structured on scientific and technical collaboration with external biotechnology partners (governmental and industrial) that are innovative leaders in their field. This working process includes ‘state of the art’ vaccine discovery, with subsequent in vivo evaluation of these vaccine candidates in animal models for immunogenicity and/or efficacy. In addition, manufacturing processes are optimized and established, and the resulting clinical trial material is evaluated in human clinical studies.
The Bacterial Vaccines department has well equipped laboratories, and the possibility to acquire additional equipment and laboratory space. Crucell’s support departments, such as Vaccine Process & Analytical Development (VPAD) and Quality Control (QC), provide expertise to the Bacterial Vaccines department and its external partners, for the development of their prototype vaccines.
Job Description:
The Bacterial Vaccine department is recruiting a qualified Senior Scientist physico-chemical analytics (postdoctoral scientist) for two major vaccine projects. In the course of your work, you will interact with our external partners, and with various Crucell support departments and governance bodies (CMC council, specifications board, etc.) You will be expected to perform laboratory work in person, and will lead a small group of technicians to assist you in your tasks.
The external biotechnology partners are in charge of developing production processes and analytical tests (for in-process and quality control), and they provide facilities for vaccine development and Quality Control (QC). The partners can also take charge of some aspects of quality affairs (QA), regulatory affairs, and sponsor and organize clinical studies. Directly, or indirectly via a contract manufacturing organization (CMO), the partners are responsible for the production of clinical trial material (CTM) for Phase I/IIa studies in human.
The Bacterial Vaccines department plans to build up independent analytical capabilities, centered mainly around carbohydrate and protein antigens. This position has a main focus on physico-chemical expertise (HPLC, MS, NMR, etc.). Actual carbohydrate/conjugate experience (preferably in an industrial setting) would strongly benefit Bacterial Vaccines projects. Apart from Bacterial Vaccines own resources, access to analytical facility (e.g. NMR) is also possible within Crucell and/or with external collaborators.
Your main responsibilities will be:
• Analyze carbohydrate-, protein-, or glycoconjugate-based antigens.
• Detect, analyze and quantify target antigens, pure or in complex matrices.
• Determine size, shape, behavior of such antigens.
• Detect, analyze and quantify impurities and contaminants.
• Know, implement and improve established tests for carbohydrates, proteins, glycoconjugates, and particle-based vaccines.
• Develop new analytical tests (evaluate LoD, LoQ, accuracy, etc.)
• With help from product development specialists, design and implement analytical panels for in-process control (IPC), product characterization, and product release.
• Help quality and regulatory specialists draft new product specifications.
• Provide elements of test qualification and validation for transfer to Crucell’s support departments.
• Develop and implement analytical tests alone and in collaboration with our external partners.
• Evaluate and transfer analytical tests from external partners to our laboratory and to Crucell’s QC department.
• Supervise equipment selection, purchase and maintenance for the analytical laboratory.
• Supervise a small team of analytical technicians and/or (junior) scientists.
Qualifications
Education:
• Ph.D. or equivalent.
• Physico-chemical analytics specialist.
Experience:
• Postdoc plus minimal two years of professional experience (industry is a plus).
• Experience with physico-chemical analysis of carbohydrates (polysaccharides), proteins and glycoconjugates.
Specific knowledge:
• Knowledge of “classical” and recent carbohydrate literature.
• Knowledge of assay qualification and validation (ICH guidelines).
• Must have: HPLC (SEC, RP, NP, etc.), IC (HPAEC-PAD), Multi-Angle Light Scattering (MALS), MS, NMR, colorimetric assays, carbohydrate analysis classical methods (hydrolysis, hydrazinolysis, methanolysis, methylation, etc.)
• Nice to have: GC-MS, Differential Scanning Calorimetry (DSC), Asymmetric-Flow Field Flow Fractionation (AF4), CD, capillary electrophoresis, etc.
Competences:
• Problem solver, including through hands-on laboratories experiments.
• Focused on project goals (milestones and deliverables).
• Team player.
• Leadership: able to manage work for a small group of technicians.
• Organize data efficiently (databases) and with data security in mind.
• Equip analytical laboratory with ‘state of the art’ equipment.
• Safety-conscious.
• Language skills: fluent English.
• Computer skills (Excel, statistical analysis, databases, etc.)
Primary Location:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Crucell Holland BV (8852)
Job Function: R&D
Description
Crucell is a global biotech company that focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
Within Crucell talented, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Crucell.
For our Bacterial Vaccines department we are currently seeking for a fulltime
Senior Scientist physico-chemical analytics (m/f)
Department/Project:
The Bacterial Vaccines department is working on the discovery and early development of novel vaccines for bacterial infectious diseases. It strives to address unmet medical needs, such as bacteremia (sepsis), meningitis, and respiratory tract and nosocomial infections. Projects at the Bacterial Vaccines department are primarily structured on scientific and technical collaboration with external biotechnology partners (governmental and industrial) that are innovative leaders in their field. This working process includes ‘state of the art’ vaccine discovery, with subsequent in vivo evaluation of these vaccine candidates in animal models for immunogenicity and/or efficacy. In addition, manufacturing processes are optimized and established, and the resulting clinical trial material is evaluated in human clinical studies.
The Bacterial Vaccines department has well equipped laboratories, and the possibility to acquire additional equipment and laboratory space. Crucell’s support departments, such as Vaccine Process & Analytical Development (VPAD) and Quality Control (QC), provide expertise to the Bacterial Vaccines department and its external partners, for the development of their prototype vaccines.
Job Description:
The Bacterial Vaccine department is recruiting a qualified Senior Scientist physico-chemical analytics (postdoctoral scientist) for two major vaccine projects. In the course of your work, you will interact with our external partners, and with various Crucell support departments and governance bodies (CMC council, specifications board, etc.) You will be expected to perform laboratory work in person, and will lead a small group of technicians to assist you in your tasks.
The external biotechnology partners are in charge of developing production processes and analytical tests (for in-process and quality control), and they provide facilities for vaccine development and Quality Control (QC). The partners can also take charge of some aspects of quality affairs (QA), regulatory affairs, and sponsor and organize clinical studies. Directly, or indirectly via a contract manufacturing organization (CMO), the partners are responsible for the production of clinical trial material (CTM) for Phase I/IIa studies in human.
The Bacterial Vaccines department plans to build up independent analytical capabilities, centered mainly around carbohydrate and protein antigens. This position has a main focus on physico-chemical expertise (HPLC, MS, NMR, etc.). Actual carbohydrate/conjugate experience (preferably in an industrial setting) would strongly benefit Bacterial Vaccines projects. Apart from Bacterial Vaccines own resources, access to analytical facility (e.g. NMR) is also possible within Crucell and/or with external collaborators.
Your main responsibilities will be:
• Analyze carbohydrate-, protein-, or glycoconjugate-based antigens.
• Detect, analyze and quantify target antigens, pure or in complex matrices.
• Determine size, shape, behavior of such antigens.
• Detect, analyze and quantify impurities and contaminants.
• Know, implement and improve established tests for carbohydrates, proteins, glycoconjugates, and particle-based vaccines.
• Develop new analytical tests (evaluate LoD, LoQ, accuracy, etc.)
• With help from product development specialists, design and implement analytical panels for in-process control (IPC), product characterization, and product release.
• Help quality and regulatory specialists draft new product specifications.
• Provide elements of test qualification and validation for transfer to Crucell’s support departments.
• Develop and implement analytical tests alone and in collaboration with our external partners.
• Evaluate and transfer analytical tests from external partners to our laboratory and to Crucell’s QC department.
• Supervise equipment selection, purchase and maintenance for the analytical laboratory.
• Supervise a small team of analytical technicians and/or (junior) scientists.
Qualifications
Education:
• Ph.D. or equivalent.
• Physico-chemical analytics specialist.
Experience:
• Postdoc plus minimal two years of professional experience (industry is a plus).
• Experience with physico-chemical analysis of carbohydrates (polysaccharides), proteins and glycoconjugates.
Specific knowledge:
• Knowledge of “classical” and recent carbohydrate literature.
• Knowledge of assay qualification and validation (ICH guidelines).
• Must have: HPLC (SEC, RP, NP, etc.), IC (HPAEC-PAD), Multi-Angle Light Scattering (MALS), MS, NMR, colorimetric assays, carbohydrate analysis classical methods (hydrolysis, hydrazinolysis, methanolysis, methylation, etc.)
• Nice to have: GC-MS, Differential Scanning Calorimetry (DSC), Asymmetric-Flow Field Flow Fractionation (AF4), CD, capillary electrophoresis, etc.
Competences:
• Problem solver, including through hands-on laboratories experiments.
• Focused on project goals (milestones and deliverables).
• Team player.
• Leadership: able to manage work for a small group of technicians.
• Organize data efficiently (databases) and with data security in mind.
• Equip analytical laboratory with ‘state of the art’ equipment.
• Safety-conscious.
• Language skills: fluent English.
• Computer skills (Excel, statistical analysis, databases, etc.)
Primary Location:Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization: Crucell Holland BV (8852)
Job Function: R&D