P2410 - Senior Scientist, Analytical Development and Quality Control
vor 3 Wochen
Debiopharm is privately-owned Swiss biopharmaceutical company commitmented to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Debiopharm International SA aims to develop innovative therapies via our unique “development only” business model, acting as a bridge between disruptive discovery products and patient access in international markets. At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases through working on innovative medicines for patients. Join our team at Debiopharm where together, we innovate, we impact, and we grow.
For our Pharmaceutical Development organization based at our Headquarters in Lausanne, we are looking for a
Senior Scientist (Associate Principal), Analytical Development and Quality Control
Under the responsibility of the Head of Analytical Development & Quality Control (AD&QC), the role brings a strong technical expertise to the Pharmaceutical Development Department for the analytical development and control of investigational medicinal product (new chemical entities), manufactured by selected CDMOs.
The role is to define the analytical development strategy and lead the analytical development activities on drug substances (DS) and drug products (DP) with constant awareness of risks, efficiency and quality. The candidate must have a thorough understanding of pharmaceutical development. The expert participates in matrix-based teams with a strong spirit of collaboration.
Your responsibilities will be but not limited to:
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 complianceRequirements
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 organizationBenefits
Debiopharm offers employees:
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.The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.
Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.
Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.
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