Life Science

Senior Analytical Scientist



My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their analytical team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior Analytical Scientist with a strong expertise on Drug Substance and powder.

Responsibilities:


• Support to analytical development plan and stability program for primarily Drug Substance and possibly Drug Product in cooperation with external partner and internal experts, in line with business priorities, following a Quality by Design framework (ICH Q8, ICH Q11)
• Contribute to/or realize the conception, design, and interpretation of scientific and technical data to support projects decision making
• Apply broad and deep analytical knowledge and experience to the analytical development and characterization of drug substances and powder (e.g microscopy (SEM, TEM, SEM-EDX, ATR-FTIR), spectroscopy (FTIR, Raman, confocal RAMAN, UV-vis), laser scattering and solid-state characterization techniques (XRPD, DSC, TGA, ITC), quantification of API and impurities (HPLC, GC…)
• Design stability program in close cooperation with Internal Experts (e.g. CMC Development Expert, Head of Formulation and Process Development, Head of Chemical Development) and external partners
• Apply statistical analysis for interpretation of analytical and stability data, set the shelf life and storage conditions of drug substances
• Solve complex problems (e.g. deviations, OOS) through collaborations with others
•Create and enhance collaborative and trusting relationships with external partners
• Lead liaison with Operations to prepare, execute and support technical transfer to the late stage of development,
• Support Operations by providing scientific and technical expertise to ensure maintenance of in market products
• Manage to set a risk management table, update it as necessary and escalade in a timely manner any critical risk to the Supervisor
• Contribute to define and execute mitigation and contingency plan
• Plan efficiently activities and ensure strict monitoring of milestones and budget
• Laad and/or approve key documents such as: method development reports, validation protocols/reports, and justification of specifications, stability protocols/reports, shelf life and storage conditions statement and relevant sections of regulatory filings (DMF, IND, IMPD, NDA etc.)
• Write standard operating procedures and working instructions required by the activities
• Manage close oversight of GMP activities that are conducted externally to ensure at each stage of development an appropriate level of quality requirements and report in a timely manner any major or critical issue
• Contribute that external partners operate in compliance with Safety, Health and Environment of the company
• Participate to the preparation of audits and inspections, internally or at external partner’ site
• Maintain awareness of cutting-edge and specific technologies in the field of small molecule and ensure knowledge acquisition
• Ensure to implement regional regulatory requirements and guidelines that impact analytical sciences in close cooperation with CMC Development Expert and other functions
• Maintain current awareness of GMP and other regulations, guidance documents
• Contribute to publish/present in high quality journals/conferences in line with the function strategy

Your profile:

  • PhD with 5 years of working experience or MS with 15 years of working experience in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or closely related to the field
  • Strong track record of success with oral and topical developments
  • Experience working with external partners (e.g. CDMO, CRO, Academic)
  • In-depth scientific knowledge and experience in developing and validating analytical methods, covering different technics and methods (e.g. microscopy (SEM, TEM, SEM-EDX, ATR-FTIR), spectroscopy (FTIR, Raman, confocal RAMAN, UV-vis), laser scattering and solid-state characterization techniques (XRPD, DSC, TGA, ITC), powder rheology, surface area determination by BET, particle size and particle shape and morphology techniques
  • Solid understanding of characterization, technology transfer and troubleshooting when it comes to drug substances (Oral and Topical)
  • Fluency in English, both spoken and written, any other language an asset


For more details, please contact Marine Dollat at mdollat@axepta.com



Senior Medical Device & Packaging Expert – auto-injector or pre-filled Syringe

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a senior a medical device technology and packaging expert to provide to lead, design and oversee packaging and medical device technology strategy development (auto-injector or pre-filled Syringe).

Your responsibilities:

  • Lead and manage technical activities to address complex design, development, operational issues for the preparation and timely delivery of Primary and Secondary Packaging for combination products and topical delivery systems
  • Proposes the strategy for developing human factor engineering program for combination products
  • Contributes to develop early and late phase packaging and medical devices (e.g. delivery system for combination products)
  • Proactively contribute to implement regional regulatory requirements and guidelines that impact packaging and medical device activities in close cooperation with Pharmaceutical Development Expert
  • Interact closely with external partner to ensure selection of packaging and medical devices
  • Contributes to implement, with internal partners and external partners, scientific programs to ensure adequacy of the packaging and medical device solutions: leachable & extractible studies, shipment studies
  • Author, review and/or approve key documents such as development reports, validation reports, and relevant sections of regulatory filings (IND, IMPD, CTD)

Your profile:

  • PhD in Chemistry, Pharmaceutical Sciences, Pharmacist, MS in Chemical Engineering or closely related to the field with at least 10+ years of relevant experience in pharmaceutical/medical device industry
  • You have excellent knowledge of Established track record of success with combination products development programs
  • You have demonstrated a successful experience with external partners
  • You have excellent knowledge in developing primary and secondary packaging, medical devices
  • You have excellent knowledge of cGMP, 21CFR820, ISO13485, ICH guidance’s, ISO standards and applicable guidelines
  • You have demonstrated a successful experience related CMC sections of IND/IMPD and NDA/CTD/BLA regulatory submissions
  • You speak and write English fluently

For more details, please contact Marine Dollat at mdollat@axepta.com

Global Program Manager biologics phase III



My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior Global Program Manager (expert in phase III and biological products) to provide day-to-day project management leadership to global drug development project teams. He/she will maintain project plans and budgets, organize and lead project team meetings to meet goals

YOUR RESPONSIBILITIES:

  • Bring strong expertise with biological product development plans
  • Coordinates global, cross-functional, complex drug development project teams and provides advanced project management support, including action item tracking, organization and communication of materials.
  • Organizes interdepartmental activities to ensure completion of assigned projects within scope, on schedule and within budget constraints.
  • Identifies, monitors, and analyzes business project risks and prepares project planning contingency scenarios.
  • Ensures accurate tracking and reporting of project milestones and deliverables
  • Identifies and communicates resource constraints to senior management.
  • Prepares project updates for governance meetings and clearly communicates status in written documents and presentations.
  • Ensures documentation of, and access to, key project documents, presentations and data.
  • Assumes full responsibility for managing specific aspects of the project as designated by team leadership
  •  Bring a strong expertise with CMC aspects and market access.

Expected qualifications:

  • Bachelor or PhD degree (MBA)
  • At least ten years of relevant experience in experience in a Biopharma or Biotech environment with and seven years in a similar position in Project Management
  • Strong expertise in managing phase III and biological product.
  • Thorough understanding of the drug development processes
  • Hands-on expertise with project management tools (knowledge of Planiswere program will be a plus)
  • Ability to work on a Senior / Strategic level
  • Good understanding of financial and resource planning systems and processes and ability to coordinate project level budget/resource estimates and manage actuals vs. plan
  • Good experience with regulatory aspect (CMC) and market access
  • Good communication
  • Fluent in English

For more details, please contact Marine Dollat at mdollat@axepta.com