5 Years+ Experience jobs in Austria (4), Belgium (10), Denmark (10), France (12), Germany (15), Greece (3), Hungary (2), Ireland (18), Italy (2), Malta (1), Multiple Countries (17), Netherlands (3), Poland (8), Portugal (2), Romania (3), Slovenia (1), Spain (7), Sweden (1), Switzerland (21) and United Kingdom (27).
This role is focused on providing advanced technical expertise in the manufacturing processes for sterile and biologics products. Oversee the technical transfer of manufacturing...
Support our multi-disciplinary team in the oncology program, playing a critical role in clinical development. Provide medical expertise to additional teams, optimizing the...
You will be responsible for providing medical safety expertise for the benefit/risk assessment of products in clinical development, with a specific focus on our key biologic...
Responsible for overall quality of AbbVie products which may include small molecule pharmaceuticals and/or biologics, combination products to ensure business objectives are met...
Serving as the primary QP at ATI for aseptically manufactured, parenteral products. Coaching and mentoring quality colleagues to develop problem-solving, decision-making, and...
Develop and maintain strong working relationships with external stakeholders and engage in discussions of science and strategy with both clients and external experts; Demonstrate...
Lead the Neurosciences medical affairs team in Spain; Contribute to the development of the medical plan by understanding patients and health professionals’ needs, generating the...
Leading team of scientists and research associates for upstream activities; this includes planning experiments, communicating company and program priorities, and reviewing data...
The Quality Director will provide leadership and daily management of the site Quality Assurance, Validation and Quality Control Departments. Quality Director will also be...
Build awareness of Ascendis Pharma and our TransCon technology in the endocrinology community; Identify and engage with key opinion leaders (KOLs), rising stars, and reference...
Maintain and improve GMP/GDP QMS in compliance with company policies and global regulations; Ensure manufacturing, testing, and distribution meet cGMP requirements Conduct and...
Manage a team of Bioprocess Engineers. Responsible for all process procedures, MES recipes oversight and release, ensuring compliance with the related Bioconjugates SOPs....
Key contributor to Nitrosamine unit concerning regulatory CMC to execute according to applicable international standards in time and quality. Proactively identify and mitigate...
In this senior leadership role, you will shape the strategy for our Phase II-III oncology programs, ensuring excellence in clinical development. With extensive global engagement...
Provide expert advice on the design and implementation of RWE studies. Identify evidence gaps and recommend appropriate study types to fill these gaps. Develop and manage the...
You will help develop and execute Precision Medicine regulatory strategy in alignment with the drug global regulatory strategy and in compliance with the appropriate IVD...
You will be responsible for ÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂthe quality oversight of the GCP activities related to clinical trials. The primary responsibility is to ensure that...
You will be responsible for leading development projects, depending on their complexity and phase, from preclinical to commercial launch and life cycle management. You will define...
Execute medium to high-throughput assays for drug discovery and further compound pharmacological characterization. Supervise cell cultures in ongoing projects and eventually...
Oversee development and manufacturing activities performed at partnered CMOs, including troubleshooting, process characterization, and process performance qualification. Develop...
Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines. Plans day to day activities for monitoring of a clinical study and sets...
Your role will involve the isolation, and banking of human primary immune cells, and the design and execution of various in vitro cell-based bioassays. As part of your role, you...
You lead CMO vendor teams for daily operational management and coordinate meetings with UCB multifunctional teams. You participate in CMO selection for new and existing products...
In this role, you will develop and embed a consistent Quality Culture across all affiliates, ensuring that robust quality systems and processes are in place to support Sobi’s...
You will be the key technical leader and innovator for our upstream process technology at our dynamic site. Your expertise will be pivotal in coordinating with various department...
This role will be responsible for provision of analytical methods, data and information using analytical techniques in supporting site manufacturing processes and network projects...
He/she drives internal and external efforts with the aim of developing, producing and characterizing these therapeutics antibodies for early and late stage clinical programs up to...
Lead the scientific and operational design, conduct, implementation, and analysis of non-clinical and clinical development DMPK, ADME, DDI and Bioanalysis studies for small...
This position will be primarily responsible for ensuring PV activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally...
Represents Gilead’s products and services to a defined customer base within a specific geographic area; Utilizes a level of product and therapeutic disease working knowledge to...
The position is responsible for monitoring and supporting the quality performance of contract manufacturing organizations and material suppliers to all applicable GXP standards...
The role involves the design and development of state-of-the-art biologics characterisation tools and approaches that are delivered internally and through external Contract...
The role will involve managing and participating in the development and implementation of regulatory strategy for specific programmes and may take the lead on the design and...
Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan. Provide...
You will conduct activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risk for the assigned products throughout...
Optimize nonclinical development plans for products. Collaborate with project/asset teams to deliver optimized development plans. Handle non-clinical drug safety aspects in various...
Deliver process know-how, scientific expertise as well as operational excellence with regard to the cleaning of equipments used for the biopharma API production. Support the MSAT...
Lead and/or supervise the design and development of (oligonucleotide) synthesis and purification processes for the manufacture of API using the most modern technologies. Provide...
In your role within the Pharmacokinetic Sciences (PKS) group, you will provide scientific input into drug discovery and/or development programs of our clients and establish...
This position provides strategic oversight of PV quality systems, audits, and inspections while ensuring compliance with global and regional regulatory requirements. The individual...
Provide European regulatory strategy support for assigned projects, products and non-project work. Act as a specialist in the area of oncology. Represent Regulatory Affairs...
Acts as Single Point of Contact/SPOC for all quality related activities at the External Supplier and establishing good working relationships with clear communication and defined...
This position is responsible for working with the physicians and other clinical scientists within Early Clinical Development to provide clinical research support for early phase...
Conduct protein analysis with use of Mass Spectrometry based methods, e.g peptide mapping, disulphide bridges mapping, post translational modifications, intact mass profiling etc...
You will oversee data management activities associated with clinical drug development for all clinical trials in Ascendis’ rare endocrinology portfolio. Furthermore, the duties...
Develop and maintain the highest scientific and medical knowledge in the relevant fields and be acknowledged internally and externally as an expert and provide medical support to...
Plan and design own experiments for development of downstream processes for therapeutic proteins. Design and execution of high throughput chromatography methods. Ensure that...
Oversee and guide various programs from H2L to IND program utilizing multiple modalities including small molecules, ASOs, and biologics. Lead multiple project teams in a matrix...
Responsible for ensuring compliance with global regulatory requirements, development of compliance reports/metrics and implementation of corrective/preventative actions to address...
Supervise and execute pharmaceutical processing activities to achieve operational objectives and provide daily updates on operational status. Lead and facilitate safe and effective...
Responsible for establishing governance and defining standards for interactions with third party business partners in pharmacovigilance and for coordinating PV provisions for the...
Lead the technical activities aiming to elucidate/quantify genotoxic impurities, as well as establishment of the required analytical methods, in-house or in cooperation with...
Develops and communicates CMC regulatory strategies that are in alignment with project goals and timelines. This includes formulating the global CMC strategy for the Global...
Perform qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product; Recommend the analytical characterization...
Accountable for new business generation, sales growth and customer acquisition where you will be supplying products into three clearly defined markets; Life Sciences...
Conduct pharamacokinetic data analysis, provide scientific interpretation of study results, perform clinical report writing, and independently handle interactions with clients...
You lead a team of research associates and scientists dedicated to developing and validating (bio)assays for release and stability testing of antibody products. You will focus on...
Lead Scientific Strategy: Direct the scientific strategy for the project within Global Antigen Design, operating within a fast-paced and agile environment to drive innovation and...