(Associate) Scientist- Team Leader Downstream Processing

Transcription

1 Chemistry Manufacturing & Controls (Associate) Scientist- Team Leader Downstream Processing Job Description The Downstream processing (DSP) team (~20 people) within the CMC (Chemistry Manufacturing and Control) PD&T (Pharmaceutical Development & Technology) Department at Ablynx is looking for a (Associate) Scientist-Team Leader to strengthen the team responsible for: The Operational platform for CMC grade purifications for all projects running in Ablynx, using a variety of chromatography and filtration techniques The development of DSP processes for Nanobody Development Candidates during pre-clinical development Large-scale DSP platform including in-house production of non-gmp Drug Substance for toxicological studies DSP-related activities to support late-stage projects (e.g. PAR studies and process validation). DSP Technology and platform improvement activities to keep track of and implement new techniques and developments in the field. The successful candidate will head a small team of 3 to 4 (senior) research associates and will be responsible for the planning, coordination, follow-up and reporting of assigned line and project activities. Responsibilities

2 Responsible for the research approach and results of an intradepartmental team within the scope of assigned project activities People management: drives recruitment of level (senior) research associate and below, responsible for training, development, coaching and performance management of your direct reports Uses state-of-the-art equipment and Design-of-Experiments (DOE) to perform DSP process development using the required chromatography techniques and filtration approaches Plans, coordinates and follows-up on weekly bases the generic purifications running within the DSP team. Strongly interacts with the CMC Upstream and Analytics subteams to streamline these different activities and to keep a holistic view in successfully progressing the different purifications and projects Represents the CMC department as core team member in project meetings Reports about the results and progress to the line manager, project team, project leader and/or external parties in a clear and concise manner. Provides strategic guidance where needed Prepares high level reports, summaries, manuscripts and other documents as appropriate Profile The candidate should: Hold a Master or PhD in Life sciences (such as Biology, Bioengineering, Industrial Sciences, Biotechnology, (Bio)Chemistry, Pharmacology or equivalent)

3 Have strong experience in purification (chromatography and filtration techniques) of biologicals and knowledge of DSP process development for biologicals Experience in using AKTA equipment and high throughput purification methods and equipment (TECAN/JANUS robotics) is a plus Experience in Design-of-Experiments (DOE) is a plus Experience in excel macro programming is a plus Experience in Biotech/Pharma is a plus Have excellent writing, presentation and communication skills (fluent in English, written and spoken) Demonstrate proven organizational and coordination skills Have proven leadership, people management and managerial skills Have sense for initiative, quality, accuracy and detail Have the ability and desire to work in a fast-paced, dynamic environment Be a team player, enthusiastic and flexible, able to build bridges between groups and departments The CV of the applicant should be in English, and include a paragraph specifying the technical expertise and people management experiences. Apply here;

4 (Jr) Research Associate Downstream Process Development - TEMP 1 year Job Description The DownStream Process (DSP) Development team (~ 20 people) within the Chemistry Manufacturing and Control (CMC) Pharmaceutical Development & Technology Department at Ablynx is looking for a (Jr) Research Associate who will be part of the team responsible for: Generic purifications to deliver CMC grade Nanobody batches for all projects running in Ablynx Development of DSP processes for Nanobody Development Candidates during pre-clinical development Large-scale DSP activities (purification of tens to thousands of grams), including in-house production of non-gmp DS for toxicology studies DSP-related activities to support late-stage projects (e.g. PAR studies and process validation). DSP platform improvement and new Technology exploration Responsibilities Uses state-of-the-art equipment and different types of chromatography (affinity, IEX, HIC, mixed mode) and filtration (µ-filtration and ultrafiltration TFF, depth filtration) techniques to perform generic purifications in a timely manner with eye for quality Reports about the results and progress to the line manager

5 Prepares experimental reports (eln) and meeting summaries/presentations Profile The candidate should: Have degree B. Sc., M. Sc. (Industrial Engineer), Master in Biochemistry/ Biotechnology or equivalent Have a hands-on mentality Have excellent communication skills (fluent in English, written and spoken) Have knowledge of Word, Powerpoint and Excel Have good organizational skills Have sense for initiative, quality and accuracy Have the ability and desire to work in a fast-paced, dynamic environment Be a team player, enthusiastic and flexible Apply here;

6 (Sr) Research Associate Downstream Process Development Job Description The DownStream Process (DSP) Development team (~ 20 people) within the Chemistry Manufacturing and Control (CMC) Pharmaceutical Development & Technology Department at Ablynx is looking for an experienced (Sr) Research Associate who will be part of the team responsible for: Generic purifications to deliver CMC grade Nanobody batches for all projects running in Ablynx, Development of DSP processes for Nanobody Development Candidates during pre-clinical development Large-scale DSP activities (purification of tens to thousands of grams), including in-house production of non-gmp DS for toxicology (Tox) studies DSP-related activities to support late-stage projects (e.g. PAR studies and process validation). DSP platform improvement and new Technology exploration Responsibilities Uses state-of-the-art equipment and different types of chromatography (affinity, IEX, HIC, mixed mode) and filtration (µ-filtration and ultrafiltration TFF, depth filtration) techniques to perform generic purifications in a timely manner with eye for quality Is part of a team that, using a Design-of-experiment (Doe) approach, develops a DSP process for Nanobody Development Candidates, which has a high process yield and

7 which is robust, scalable and which delivers high quality Nanobody material to be transferred to a CMO of choice for GMP manufacturing of Nanobody batches for clinical studies Is part of the team that performs large-scale DSP campaigns to facilitate Tech Transfers to CMO (Man-in-Plant runs) and provide non-gmp DS material for Tox studies Is responsible for exploring new DSP-related technologies and improving platform work flows Reports about the results and progress to the line manager, project team, project leader Prepares experimental reports (eln), meeting summaries/presentations and drafts working protocols in English Profile The candidate should: Have degree B. Sc., M. Sc. Biotechnology/(Bio)chemistry/Pharmacology/Industrial engineer or equivalent with at least 2 to 5 years of experience in laboratory work Have hands-on experience in purification of biologicals and preferably knowledge of DSP process development (different types of resin screening, Design-of-Experiment (DOE) approach for process development, gradient optimization, etc ) Have hands-on experience in using (AKTA) chromatography and filtration equipment Have excellent communication skills (fluent in English, written and spoken)

8 Have knowledge of Word, Powerpoint and Excel Apply here;

9 Associate CMC Analytics - TEMP 1y Looking for a Research Associate involved in making of Nanobody based Pharmaceutical drugs Ablynx is a biopharmaceutical company dedicated to creating new antibody-based medicines called Nanobodies which will make a real difference to society. Ablynx has currently over 400 people working on the development of Nanobodies for the treatment of a wide range of diseases, including inflammation, haematology, respiratory disease, immuno-oncology and oncology. The Analytics group of the CMC Pharmaceutical Development & Technology Department at Ablynx is looking for a Research Associate that will be part of the team responsible for the in depth analysis of the quality and stability of lead Nanobodies during pre-clinical and clinical development. A multitude of assays is being used in the team including standard techniques such as Reversed Phase, Size Exclusion and many others (U)HPLC chromatography, Mass Spectrometry, UV- and fluorescence spectroscopy, iso-electric focusing (IEF), Dynamic Light Scattering (DLS), Differential Scanning Calorimetry (DSC), Micro-Flow Imaging (MFI), osmolality and viscosity measurements, endotoxin testing, Host Cell Proteins assay,. Those techniques are applied: in stability studies, stress testing and the development of stable formulations to control the quality and consistency of Nanobody productions and thereby assist in the development of a largescale manufacturing process for a specific lead Nanobody

10 to perform physico-chemical characterization of Nanobodies, identification of product variants and investigation of degradation pathways Profile: Bachelor or Master degree in life sciences (such as Degree of Professional Bachelor in Laboratory Technology or Biotechnology (Laboratory Technician A1), Bachelor or Master in Industrial Sciences (Industrial Engineer), Biochemistry, Biotechnology, Biomedical sciences or similar) Hands-on mentality and comfortable with controlling high tech instrumentation Able to work independently and in team, enthusiastic and selfmotivated Good writing and presentation skills Ability and desire to work in a fast-paced, dynamic environment Good Sense for initiative, quality, accuracy and detail Experience with some of the above-mentioned techniques is preferred. Knowledge of English The CV of the applicant should be in English, and include a paragraph specifying the technical expertise. Apply here;

11 Research Associate Nanobody Production CMC - TEMP 1y Looking for a Research Associate involved in making of Nanobody based pharmaceutical drugs Ablynx is a biopharmaceutical company dedicated to creating new antibody-based medicines called Nanobodies which will make a real difference to society. Ablynx has currently over 400 people working on the development of Nanobodies for the treatment of a wide range of diseases, including inflammation, haematology, respiratory disease, immuno-oncology and oncology. The USP (Upstream Processing) department is an important unit that makes hundreds of different Nanobodies per year for the evaluation in different disease models. The unit has a strong involvement in the selection of the Nanobody medicines that will eventually be evaluated in patients. A wide variety of activities are ongoing in our USP department such as the cloning of Nanobodies, generating recombinant bacteria and yeast (host creation), small and large scale productions from 24-well scale to 2L fermentations up to 100L steel fermentations, etc. A multitude of assays are being used in the team including standard techniques for the development of biopharmaceutical medicines such as SDS-PAGE, Western blotting, Reverse Phase Chromatography, Size Exclusion and many others. The current USP team exist of 12 experienced people who will guide you through the complete process of Nanobody development and they will train you in the use of new technologies. We expect the candidate to be an enthusiastic team player eager to make and bring new Nanobody medicines to the patient. Candidates who want to strengthen the Upstream Processing Team should describe their knowledge in Molecular Biology, Recombinant DNA Technology, Protein Production and other experiences they find

12 relevant and which show their motivation for joining our team. This is a temporary position for 1 year, but will likely be turned into a permanent position. Profile: Bachelor or Master degree in life sciences (such as Degree of Professional Bachelor in Laboratory Technology or Biotechnology (Laboratory Technician A1), Bachelor or Master in Industrial Sciences (Industrial Engineer), Biochemistry, Biotechnology, Biomedical sciences, Biotechnology, Biochemistry or similar) Hands-on mentality and comfortable with controlling high tech instrumentation Able to work independently and in team, enthusiastic and selfmotivated Good writing and presentation skills Ability and desire to work in a fast-paced, dynamic environment Good Sense for initiative, quality, accuracy and detail No previous experience in industry is required Experience and good knowledge in cloning techniques, qpcr, or fed-batch fermentations is preferred Apply here;

13 Senior Research Associate CMC Analytics Looking for a Senior Research Associate involved in making of Nanobody based Pharmaceutical drugs Ablynx is a biopharmaceutical company dedicated to creating new antibody-based medicines called Nanobodies which will make a real difference to society. Ablynx has currently over 400 people working on the development of Nanobodies for the treatment of a wide range of diseases, including inflammation, haematology, respiratory disease, immuno-oncology and oncology. The Analytics group of the CMC Pharmaceutical Development & Technology Department at Ablynx is looking for an experienced Research Associate that will be part of the team responsible for the in depth analysis of the quality and stability of lead Nanobodies during pre-clinical and clinical development. A multitude of assays is being used in the team including standard techniques such as Reversed Phase, Size Exclusion and other (U)HPLC chromatography, Mass Spectrometry, UV- and fluorescence spectroscopy, capillary electrophoresis, Dynamic Light Scattering (DLS), Differential Scanning Calorimetry (DSC), Micro-Flow Imaging (MFI), Light obscuration, osmolality and viscosity measurements, endotoxin testing, Host Cell Proteins assay,. Those techniques are applied: in stability studies, stress testing and the development of stable formulations to control the quality and consistency of Nanobody productions and thereby assist in the development of a largescale manufacturing process for a specific lead Nanobody

14 to perform physico-chemical characterization of Nanobodies, identification of product variants and investigation of degradation pathways Profile: Bachelor or Master degree in life sciences (such as Degree of Professional Bachelor in Laboratory Technology or Biotechnology (Laboratory Technician A1), Bachelor or Master in Industrial Sciences (Industrial Engineer), Biochemistry, Biotechnology, Biomedical sciences or similar) Hands-on mentality and comfortable with controlling high tech instrumentation Able to work independently and in team, enthusiastic and selfmotivated Good writing and presentation skills Ability and desire to work in a fast-paced, dynamic environment Good sense for initiative, quality, accuracy and detail Team player Experience in physico-chemical analysis of proteins is an asset Ability to design experiments independently, to plan and perform experiments and to prepare concise reports of the results in English. Previous analytical experience (at least 5 years) in industry and with some of the above-mentioned techniques is required. Knowledge of English The CV of the applicant should be in English, and include a paragraph specifying the technical expertise. Apply here;

15 Study Manager Manufacturing With further growth on the horizon the Nanobody Contract Manufacturing group is looking for a highly motivated Scientist/Manufacturing professional to strengthen the growing team. The Study Manager Manufacturing will be charged to provide technical and organizational support to ensure an efficient execution of internal CMC development activities, technology transfer and further activities when the product is transferred at the CMO; assuring quality and timelines are delivered to supply demands. The candidate will report to Ablynx s Senior Director CMC Manufacturing, and work alongside six colleagues to drive specifically assigned programs consisting of both proprietary and partnership/collaborative products. The incumbent will operate as part of a core cross functional team inputting into strategic decisions relating to product development and will be responsible for managing multiple internal and external stakeholder relationships. The objective of the Study Manager Manufacturing will be to coordinate project work with external contract manufacturing organizations CMO s; acting as the key contact for third party contractors whilst internally providing progress reports to both the project team and head of manufacturing. He/she will also act in an advisory and consultancy role related to

16 the CMO activities with the objective to assist in CMO screening & selection, contract negotiations and regulatory submissions whilst liaising with external partners to develop/design suitable drug device delivery systems for products. Finally the Study Manager Manufacturiing will ensure that appropriate data and documentation is in-place for in-time successful regulatory submissions and assists with high-level document, manuscript preparation and review. Within this dynamic environment the Study Manager Manufacturing will be operating autonomously in a wide lens view to convert project goals into action plans, followed by implementation. Summary of Position The Study Manager Manufacturing will play a critical role both internally and externally with the opportunity to further shape and develop the SOP s within Ablynx and have an impact in the wider organization. This will be a highly visible role as you will be the leading figure for the Nanobody Contract Manufacturing group, interacting with both internal and external stakeholders. Ablynx has ambitious plans and as a key executive within the organization, there are long-term development opportunities that you could be considered for based on how the business progresses combined with your career aspirations and success.

17 Opportunity highlights Unique opportunity to join a fast-growing, entrepreneurial and innovative Biotech firm dedicated to the development of Nanobodies across key TAs spanning haematology, immunology, inflammation and immune-oncology and be part of their expansion. The opportunity is one that will enable you to lead and shape internal and external engagements; inputting into strategy and autonomously driving this collaboration towards the desired outcome. This opportunity is one that will enable you to make a significant contribution to the manufacturing, supply and commercialization of world class biologicals. This opportunity is one that will enable you to represent Ablynx to the external market; blending scientific & manufacturing rigor to achieve quality deliverables. You will have the opportunity to work alongside some of the top experts within the industry and be mentored/developed by a highly experienced senior leadership team. This opportunity is one that will enable you to make a significant contribution to achieving the objectives of Ablynx. The role will have significant impact internally and externally and offers a high degree of autonomy with the opportunity to work closely with colleagues from different functional background with a common passion for science. Key responsibilities

18 Coordinate project work with external contract manufacturing organizations (CMO s); creating a collaborative team environment to solve problems, build consensus, and proactively implement solutions and acts as the key contact for the third party contractors. Convert Ablynx project goals (Tox, cgmp-material, stability studies, regulatory filings at pre-defined milestones) into action plans, followed by implementation. Provide the appropriate technical and organizational support to ensure an efficient execution of internal CMC development activities, technology transfer and further activities at the CMO, assuring quality and timelines. Report internally about the results and progress to the project team and contributes to the project strategy. Play a cross-departmental (e.g. for Legal and Business Development, QA&QC, Regulatory Affairs, Clinical Operations) advisory and consultancy role regarding the CMO activities. Ensure that appropriate data and documentation is in-place for in-time successful regulatory submissions and assists with high-level document, manuscript preparation and review. Input into the improvement of SOP procedures internally. Experience, Knowledge and Qualifications Life science degree (BSc, MSc. PharmD, PhD or equivalent within engineering). Have strong project management skills together with initiative, quality, accuracy and an eye for detail. Possess a good knowledge of upstream & downstream processing and analytical biochemistry.

19 Experience in the application and development of cgmp production processes including transforming this into regulatory approvals and adherence with current quality requirements. Knowledge of process design, process performance validation/qualification and continuous process verification is of benefit. Strong analytical and collaboration skills. Proven team player with the ability to adapt. Experience in a highly matrix environment. Excellent oral and written communication and presentation skills are required to positively interact with external CMO s and internal customers/colleagues. Fluent in English. Apply here;

20 Clinical Development Modeling & Simulation Scientist Job Description: We re offering a full time position for a Modeling and Simulation Scientist to strengthen the Pharmacokinetics Modeling & Simulation team. A Modeling and Simulation Scientist will implement modeling and simulation strategies to streamline preclinical and clinical development plans, using Pharmacokinetics, PBPK, PK/PD modeling, Disease Progression models and Clinical Trial Simulation. He/She will provide expertise in Integrative Pharmacology or applied Modeling and Simulation and will have an active role in cross-functional teams, interfacing with discovery / CMC / pharmacology / toxicology / bioanalysis / clinical. He/she will contribute to the PK/PD Modeling & Simulation components of regulatory submissions. He/she will continuously evaluate and test new technical Modeling and Simulation approaches / platforms / tools, and actively extend the PK/PD knowledge of the nanobody platform. Externally, the Modeling and Simulation Scientist will present at scientific conferences, and will be charged to keep contacts with a network of KOL s and academics with the objective to add strategic value in the development and progression of a compound. Profile:

21 A doctoral degree (PhD, Pharm D, MD) is preferred in Pharmacokinetics, Biostatistics or a related discipline. Experience or understanding of drug development is required. Knowledge of NONMEM and/or other Modeling and Simulation tools and programming language (e.g. R, MatLab, SAS ) is a pre-requisite. Experience with large molecules or biologics would be an advantage. Ablynx works on a wide variety of disease indications, but an expertise in one of the following would be a plus: inflammation, hematology, infectious diseases, oncology. Teamwork ability and communication skills are necessary. Apply here;

22 Discovery Research Associate Discovery - Cell Based Solutions General Services (TEMP 1y) The Discovery department is looking for a Research Associate to strengthen the CBS General Services team that provides miscellaneous laboratory and administrative support to multiple project teams. Your will be part of a team that has following (not limitative) responsibilities: Manage Ablynx Mammalian Cell Collection (cell lines / primary cells) by performing cell line generation / cell line banking / PBMC preparation / cell freezing & thawing service / administration in cell collection database Protein labelling Administrator for the Ablynx Biobank collection of all Human Body Materials for scientific research. Upload scientific data on research materials in scientific databases Train people on the tools that are available for data-upload, data-retrieval & data-usage Requirements: Bachelor or master degree in a scientific area A very high sense for quality, accuracy and detail A team-oriented attitude, flexibility, enthusiasm and ability to work independently

23 A pro-active approach Solid analytical and problem solving skills Fluent knowledge of English (read / write and discuss) Knowledge of Excel, SAP (order handling module) and / or scientific databases is an asset The CV of the applicant should be in English. Apply here;

24 Research Associate Discovery - Lead Characterisation Cell Based Solutions, TEMP 1y The Lead Characterisation Unit within the Discovery department is looking for Research Associates to help in the generation of research tools and / or the screening, characterisation and understanding of the function of Nanobody lead drug candidates for various therapeutic applications. You will be working on multiple projects as a member of the technical expert team Cell Based Solutions. Your job will include one or more of following responsibilities depending on the skill team that you will join: You will use mammalian cell culture technologies including cell line generation, maintenance & quality control of cell lines (expression of target antigen, ) You perform flow cytometry experiments You perform cell-based assays (e.g. cell proliferation, ligand binding, cell signaling) Generic responsibilities: You will be involved in data analysis and prepare written reports of your results You will communicate results and observations to the team You will actively contribute to project-oriented teams Requirements: Degree of Laboratory Technician (A1), Industrial Engineer, Bachelor or Master in Molecular Biology, Biochemistry, Biotechnology or equivalent

25 Solid analytical and problem solving skills A pro-active approach and high sense for quality, accuracy and detail A team-oriented attitude, flexibility, enthusiasm and ability to work independently Ability to report and discuss experimental design and data in English Experience in one or more of the above mentioned responsibilities is an asset The CV of the applicant needs to be in English, and should include a paragraph specifying the technical expertise. Apply here;

26 Pharmacology Immunogenicity Scientist The pharmacology department develops a multitude of quantitative assays for research and development purposes, such as potency assays, biomarker assays, pharmacokinetic (PK) assays and immunogenicity (ADA) assays. The applicant is expected to support projects by taking up in particular the bioanalytical immunogenicity work packages in support of preclinical and clinical studies. A high level of quality needs to be maintained, excellent self-organization and documentation skills are therefore mandatory. The (associate) scientist will be expected to present and discuss her/his own research and give input in technical project teams. We look for individuals who have relevant assay development experience, preferably within the above mentioned technology fields. Prior experience with quantitative assays and assay validation is a plus. Key responsibilities Main responsibilities include: Scientific responsibility for immunogenicity analysis - can also be in a regulated (GLP/GCP) setting o o o Design, development and validation of immunogenicity assays Immunogenicity analysis to support (pre)clinical studies If required, transfer assays internally (to GLP facility) or outsource (and follow-up) to CRO

27 Write comprehensive bioanalytical reports (reporting language is English) Effectively report and discuss results in project teams Contribute to scientific discussions and drive technical project progress Profile PhD in a relevant field of life sciences with assay development experience during the PhD; or MSc, Bio-engineer with 5+ years of relevant experience. More experienced candidates are also encouraged to apply, as entry level will depend upon this relevant experience. Strong background in immunoassay development using technologies such as ELISA and MSD, Strong knowledge of immunogenicity; Knowledge of Bioanalytical and Immunogenicity Guidance (FDA/EMA) is a plus Excellent skills in writing reports Highly quality-oriented - Prior knowledge and experience in a regulated quality lab setting (GLP, GCP) is a big plus Excellent time management and organization skills Strong communication (verbal, written, interpersonal, listening) skills Ability to work independently with minimal supervision Ability to adapt to rapidly changing priorities Ability to multi-task and meet timelines in a fast-paced environment Team player Knowledge of English

28 Knowledge of MS Office (Word and Excel) Full time position Apply here;

29 Scientist Pharmacodynamics and Translational Medicine Job Description We re offering a full time position for a scientist with substantial research experience specifically related to the physiology of van Willebrand factor (vwf) and the pathophysiology of acquired thrombotic thrombocytopenic purpura (attp) to strengthen the Pharmacodynamics and Translational Medicine team. The main responsibility of the Pharmacodynamics and Translational Medicine sub-team within the Pharmacology department is the pharmacological characterization of lead compounds in vitro and in vivo. This will include the development of bio-assays for potency measurements and assessment of the mode of action, specificity and species cross-reactivity of the drug candidate. Furthermore, the sub-team is responsible for the design and implementation of translational strategies including animal models and the selection and development of relevant biomarker assays for pre-clinical and clinical studies and works in close collaboration with the non-clinical safety sub-team and model informed drug development department. Responsibilities You will evaluate and propose new therapeutic concepts and drug discovery project for Nanobodies as part of a hematology focus group As vwf/attp scientific expert you will support the continued clinical development of Caplacizumab and ongoing regulatory application processes

30 You will coordinate in vitro or ex vivo as well as animal efficacy studies, managing collaborative relationships with academic and industrial partners and internal parties You will design and implement translational strategies to allow smoothly transition of promising drug candidates from discovery to early clinical testing and throughout clinical development in particular in the field of hematology You will be an active member of departmental and crossdepartmental project teams that guide our different internal or partnered programs You will interact with project leaders and supervisor on a regular basis to synchronize the planned work versus the time lines and budget You will write and review study plans and reports, internal reports and regulatory documents. You will QC raw experimental data and assure adequate data transfer Profile PhD in Biochemistry, Pharmacology, Immunology or a relevant field of life sciences Research experience specifically related to the physiology of van Willebrand factor (vwf) and the pathophysiology of acquired thrombotic thrombocytopenic purpura (attp) Experience in designing and conducting cell-based in vitro, ex vivo and in vivo studies Experience in analytical method development for biologics is a benefit Quality-oriented and accurate Sense of initiative, flexible and creative

31 Excellent communication, organization and motivation skills is essential Proficient in English, knowledge of Dutch a benefit Industrial experience is an asset Experience in working in a multidisciplinary team is an asset If you possess the necessary skills and experience to fulfil this unique contract we very much look forward to hearing from you. Apply here;

32 Quality (Senior) Scientist (Ablynx GMP QC Lab) The GMP QC Lab of the Quality Department is looking for a (Senior) Scientist who acts as project lead for the GMP QC Lab in Nanobody programs. The main responsibilities are release, stability and in use testing of the pre-clinical, clinical and commercial materials under full GMP control. Responsibilities: You perform your activities in the Ablynx GMP QC Lab according to the Ablynx Quality System You represent the GMP QC Lab in cross departmental teams and in external contacts as subject matter expert You are responsible for the qualitative technology transfer of analytical methods from a Transfer Unit to the Ablynx GMP Unit, or from the Ablynx GMP Unit to a Receiving Unit You are responsible for the establishment of GMP Analytical Methods (such as SEC, RPC, IEX-HPLC, cief, CGE, CE-IEF, UV spectrometry, compendial methods, and potency assays (ELISA or cell based assays)) You are responsible for the establishment of technical instructions of the systems used in the GMP QC Lab You perform method qualification and / or validation according to current GMP regulations, ICH guidelines and Pharmacopeia. You perform method life cycle management and keep oversight over methods performed on different sites. You perform technical review of analytical results, assist and guide the (Senior) Research Associates in technical problem solving and conduct OOx-investigations if required

33 You follow up on trending data and define appropriate actions if required You suggest and develop new approaches and processes You organize trainings as subject matter expert (a.o. methods, laboratory systems) You are responsible for the coordination, execution and the quality control of the activities executed by the GMP QC Lab. The planning is discussed and aligned with the Head QC and Engineering, heading the Ablynx GMP QC lab, and the work is planned on a day to day basis with the team of Research Associates you are responsible for. You write, review and finalize the study plans and the final reports for the release testing, stability studies, method validation and any other studies performed in the GMP laboratory. Profile: PhD in a relevant field of life sciences or MSc, Bio-engineer with 7+ years of relevant experience MS Office: proficient level Fluent in Dutch and English, written and spoken You combine technical expertise with good people management skills You have experience in physico-chemical analysis and/or potency testing of proteins Experience with method validation, method life cycle management, critical reagent management, stability studies and release testing is an asset Experience with GMP guidelines and a GMP working environment

34 Knowledge of ICH and Pharmacopeia Team player, enthusiastic, independent and self-motivated Excellent communication and writing skills are required Sense for initiative, quality, accuracy and detail Please make sure your attached CV contains a paragraph containing your technical expertise Apply here;

35 GCP Quality Management Specialist Job Description: The Ablynx QA Department is looking for a Quality Management Specialist GCP. He/she will be part of the GCP QA team responsible for supporting the implementation of an integrated quality management (QM) system and for improving the current QM processes of Ablynx. Responsibilities: Set-up and maintain the quality management system in accordance with internal and external (inter)national standards and guidelines. Provide quality support of projects, incorporating a risk-based approach. Help implement the ICH GCP processes throughout the company. Identify ways to continuously improve quality and compliance with regulations and company policies, procedures and standards through partnership with the different Ablynx clinical departments. Produce/implement audit plans, oversee/perform project related audits and follow up on quality issues. Audit protocols, Clinical Study Reports and Submission Documents for GCP and regulatory acceptance. Perform internal audits to verify the compliance of the Ablynx Quality Management System. Provide quality and compliance guidance for the development and implementation of the corrective and preventive actions and monitor their status and timely closure.

36 Perform all types of GCP, GVP, GCLP (process, sites, Clinical Labs, Clinical Supplies, Diagnostic Labs, DM, reports), vendor and due diligence audits to assure that processes used and/ or data generated meet all quality standards, regulations and Ablynx requirements. Guarantee the follow-up of the corrective action/ preventive actions and continuous evaluation of third parties. Establish written agreement with third parties defining the quality requirements. Coordinate and review CAPAs from both audits and quality issues to ensure adequate root cause analysis and systemic solutions are performed. Conduct trend analyses of audit results and provide feedback to higher management and internal customers. Lead formal investigations of issues overseeing timely resolution and escalation to line management and regulatory authorities of critical observations that constitute GCP breaches. Assess new systems before implementation. Develop and deliver training for different levels of auditor skill requirements. Training on GCP/ ISO and root cause analysis for auditors, operational employees and investigators/investigator site personnel. Provide advice on GxP matters. Ensure inspection readiness by preparing the clinical departments for regulatory inspections; provide inspection management support and follow-up post-inspection. Provide support in preparation of and act as spokesperson during audits and regulatory inspections. Represent QA in interactions with internal and external contacts and with Health Authorities.

37 Profile: Education: Master or PhD in a relevant field of life science with minimally years of experience as GCP QA. Experience and professional requirements: Thorough knowledge of international GCP regulations including FDA GCP, ICH GCP, new drug/biologics regulations, current industry practice, pharmacovigilance. Understanding on how GCP relates to and interacts with the other GxP areas. Vision on QM and combination of analytical skills with process thinking. Display excellent verbal and written communication skills. Skilled at conflict resolution and negotiation. Possess excellent problem-solving and decision-making skills. Capable of working independently but also being able to function as part of a cross-functional team. Demonstrating the ability to influence. Being flexible to change priorities in a dynamic, fast moving business environment. Sense for initiative, quality, accuracy and detail. Excellent knowledge of English both in reading and writing. Please make sure your attached CV contains a paragraph containing your technical expertise Apply here;

38 Research Associate (Ablynx GMP QC Lab) - TEMP 1 y The Ablynx GMP QC Laboratory is looking for a temporary (1 year) Research Associate who will be part of the team responsible for stability testing and release testing of Nanobody drug substance and drug product. He/she will also be involved in the validation of product specific methods. Responsibilities: You execute analyses required for release testing, stability and in use testing for different Nanobody batches intended for preclinical and clinical use, compliant with GMP regulations. You execute analyses required for validation of various biophysical methods such as SDS-gel electrophoresis, normal and reversed phase chromatography (HPLC), UV spectroscopy, isoelectric focusing (cief), ELISA, cell based potency assays, ph, osmolality You assist in drafting and finalizing instructions You interpret and report the data according to the methods and compliant with GMP regulations You control that the storage of the materials is performed according to the internal guidelines and you assure that shipments of materials from and to Ablynx is executed according to the specific instructions described You are responsible for the maintenance and qualification/calibration of certain pre-defined analytical equipment (e.g. Biacore, stability chambers, cief, plate reader,...) You will plan your daily work independently according to the instructions given by your supervisor (Scientist Study Manager). You perform the experimental work and prepare written reports of your results

39 You actively support the daily maintenance of the laboratory supplies and the glassware cleaning You will regularly follow the GMP trainings Profile: Degree B. sc. or M Sc (Industrial Engineer), Master in Biochemistry/ Biotechnology or equivalent Previous experience with working in a GMP environment is a plus Experience in physico-chemical analysis of proteins is an asset but not required Experience with common HPLC equipment is an asset Team player, enthusiastic, accurate in execution and reporting Excellent communication skills Sense for initiative, quality, accuracy and detail Knowledge of Dutch and good writing skills in English Please make sure your attached CV contains a paragraph containing your technical expertise. Apply here;