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...
The primary responsibilities will include design control activities, new product development, and executing tasks related to maintaining our current products. Protein purification...
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...
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 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...