Ass. Principal Scientist, Analytical Development and Quality Control

vor 3 Wochen

Lausanne, Schweiz Debiopharm Vollzeit

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.

For our Pharmaceutical Development organization based at our Headquarters in Lausanne, we are looking for a

 

 

Associate Principal Scientist, Analytical Development and Quality Control – Biotech Products

 

Under the responsibility of the Head of Analytical Development & Quality Control, the role brings a strong technical expertise to the Pharmaceutical Development Department for the analytical development and control of biotech products, manufactured by selected CDMOs

The role is to define the analytical development strategy and lead the analytical development activities mainly on payload-linker, monoclonal antibodies (mAb) and Antibody Drug Conjugates (ADC) projects with constant awareness of risks, efficiency and quality. The candidate must have a thorough understanding of biologics development and familiarity with industry standards for characterizing mAb and ADC. The expert participates in matrix-based teams with a strong spirit of collaboration.

 

 Your responsibilities will be but not limited to:

  • Define biotech product specifications and justifications, drive and implement method development and validation strategy (non GMP and GMP) thereof, in conformity with the development status of the project,
  • Plan Stability studies and define shelf-life of GMP products, evaluation and characterization of impurities,
  • Generate critical data to support protein characterization and comparability studies.
  • 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,
  • Active interaction with other CMC team members to build the CMC development plan and ensuring execution thereof, and to support 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,
  • Provide key expertise in the development of Debiopharm ADC,
  • Contribute to the biotech programs strategy in a matrix environment with the view to speed time to clinic.

Requirements

  • Master degree or PhD in biochemistry, analytical chemistry, or a related field with relevant industry experience in Biologics R&D
  • At least 7 years industrial experience in a biotech manufacturing organization in various stages of project development, working in hands-on analytical development roles and within multidisciplinary teams (Biotech process expert, Drug product formulation/ manufacturing, Quality, Regulatory)
  • Strong background and extensive hands-on experience with development and validation of methods of analytical characterization (H/UPLC (SEC, RP, HILIC, IEX), CE (CESDS, icIEF)), mass spectrometry (LC-MS), bioassay (ligand- based and cell- based) of antibodies, and ADCs
  • Large molecule and protein characterization experience
  • Experience with comparability studies
  • Comprehensive understanding of the global development of biologicals from preclinical to late-stage clinical development,
  • Good understanding of the management of a network of CDMO’s and CRO’s
  • Good knowledge of regulatory and quality guidelines (GMP, Pharmacopeias, ICH, FDA guidance…) applicable to investigational medicinal products and biologics.
  • 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

 

Preferred experience and skills

  • Understanding of key analytical techniques applicable to peptides (i.e ADC payload linker), including H/UPLC, GC, LC-MS, GC-MS and their application to knowledge acquisition and analytical control
  • Experience with early and/or late-stage regulatory documentation

Benefits

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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