P2410 - Senior Scientist, Analytical Development and Quality Control
Debiopharm
- Lausanne
- CDI
- Temps-plein
- Lead control strategies for DS and DP, taking into consideration the status of the project, assessing risks, and ensuring their mitigation: define specification and justification thereof, lead the analytical method development and validation programs, define the stability study strategies (development and ICH studies) and evaluate the data in order to determine a shelf life, lead the evaluation and characterization of impurities
- Preparation, review, archiving of analytical CMC source documents for clinical trial application (Quality section), acting as a support to CMC Regulatory Affairs
- Implement the analytical strategies at CDMO’s/CRO’s, act as the main point of contact, manage, challenge, lead activities and assure the conformity (scientific and documentary) with external partners
- Contribute to the development of the CMC strategy in a matrix environment and provide key expertise to build a CMC plan with the view to speed time to clinic
- Support DS and DP formulation/process development with high-throughput analytical procedures
- Participate to the selection of relevant CDMOs/CROs by reviewing the proposed analytical packages
- Conduct studies to increase the understanding of the molecule and support the process development activities in collaboration with the other CMC team members, with a view to out-licensing and marketing authorization dossiers
- Drive continuous improvement initiatives within the AD&QC unit and the Pharmaceutical Development department, identifying opportunities to enhance efficiency, reliability, and compliance
- Master degree or PhD in analytical chemistry, pharmaceutical sciences, or a related field
- Minimum 5-7 years industrial experience in a pharmaceutical manufacturing organization at various stages of project development, working in hands-on analytical development roles and within multidisciplinary teams (API development, Drug product formulation/ manufacturing, Quality, Regulatory)
- Strong background and extensive hands-on experience with development and validation of various analytical methods including but not limited to chromatography (LC,GC), spectroscopy and spectrometry (MS) techniques
- Peptide characterization experience
- Good knowledge of synthetic API chemistry
- Comprehensive understanding of the global development of new chemical entities from preclinical to late-stage clinical development
- Good understanding of the management of a network of CDMO’s and CRO’s
- Strong understanding of regulatory/quality requirements (GMP, Pharmacopeias, ICH, FDA guidance…) applicable to investigational medicinal products
- Scientific curiosity, flexibility, detail-oriented and capable of identifying and solving complex scientific problems
- Excellent communication and demonstrated strong interpersonal skills, ability to work in a CMC team environment with cross functional interactions
- Ability to deliver complex objectives under challenging timelines in a rapidly changing environment. Strong resilience skills
- Excellent knowledge of English
- Motivated to undertake a diverse role and add value to the organization
- International, highly dynamic environment with a long-term vision.
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry.
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry.
- Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities.