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Senior Analytical Scientist Oral and Topical

AXEPTA SA

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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 experience working on Oral and Topical.

Senior Analytical Scientist Oral and Topical

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 experience working on Oral and Topical.

 


 


Responsibilities:



Contribute to design and oversee scientific studies in support of technical programs as they progress from early development into confirmatory development, technology transfer up to the registration and to support as needed manufacturing process at the commercial site (e.g. troubleshooting, maintenance).
Major activities include outsourcing of key activities such as product characterization, method development/optimization/validation/transfer, proposing specification and analytical control strategies, recommending stability programs and packaging safety strategy (i.e. leachable and extractible). 


 


Main activities:



• Contribute to analytical development plan and stability program for Drug Substance and Drug Product in cooperation with external partner and internal experts, in line with business priorities, following a Quality by Design framework
• Contribute to/or Support 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, performance and characterization of drug substances and drug products
• Design stability program in close cooperation with Internal Experts
• Apply statistical analysis for interpretation of analytical and stability data, set the shelf life and storage conditions of drug substances and drug products
• As a core team member, prepare and present data to internal project team meetings, and recommend sound scientific/technical decisions based on data analysis and experience
• Solve complex problems (e.g. deviations, OOS) through collaborations with others
• Recommend and technically qualify external partner and contribute to strategic partnership
• Act as key contributor to create and enhance collaborative and trusting relationships with external partners
• Ensure close 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 
• Contribute to define and execute mitigation and contingency plan
• Plan efficiently activities and ensure strict monitoring of milestones and budget
• Act as a voice and ambassador of its department at various governance bodies / meeting
• Author, review 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 (IND, IMPD, NDA etc.)
• Author standard operating procedures and working instructions required by the activities
• Ensure 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
• Actively contribute 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


 


Your profile:



• PhD+2Y or MS+5Y in Chemistry, Analytical Chemistry, Biotechnology, Pharmaceutical Sciences or closely related to the field
• Established 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. LC, GC, LC-MS, Dissolution Test)
• Solid understanding of performance, characterization, technology transfer and troubleshooting when it comes to drug substances and drug products (Oral and Topical)
• Excellent understanding of cGMP, Pharmacopeia, ICH guidance and applicable guidelines
• Experience in authoring analytical-related CMC sections of IND/IMPD and NDA/CTD regulatory submissions
• Practical experience in  implementing the principles of Quality by Design
• Excellent communication, negotiation and external follow-up
• Strong verbal and written communication skills (English)

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