Senior Scientist, Analytical Development and Services

Senior Scientist, Analytical Development and Services

Evotec

Toulouse, France

What You’ll Do:

• Lead the development & qualification of analytical methods (HPLC/CE related).
• Transfer of analytical methods to quality control (QC) or external laboratories.
• Serve as project representative for pharmaceutical product development on cross-functional project teams
• Regular analysis and in-process support to the process development team.
• Work with team members to support process development teams with high-throughput analytical procedures.
• Utilize chromatography data systems and informatics platforms to analyze and distribute analytical results.
• Work with team members on technology development to reduce the cost and improve efficiency, speed, and capacity of analytical testing and analytical methods.
• Supervise and mentor Scientists and Associates.

Who You Are:

• Master’s degree in biotechnology, bioprocess engineering, pharmaceutical sciences, biochemistry or related filed with 8+years of relevant experience or Ph.D. with 5+years of relevant experience in pharmaceutical and or/biotechnology industry.
• Practical experience in analytical techniques like H/UPLC (SEC, RP, HILIC, IEX), CE (CE-SDS, icIEF) and Protein concentration determination by A280 method.
• Advance level experience in method development, method qualification/validation and method transfer to external or quality control (QC) laboratory.
• Working experience in GLP or GxP laboratories is required.
• Large molecule and protein characterization experience is must.
• CMC Knowledge – understanding of the drug development life cycle and contribution to IND/BLA-enabling activities.
• Knowledge of regulatory guidance from the FDA and EMA for development of biologic drug products and biosimilars.
• Knowledge of USP and Ph. Eur. as it relates to biologics development
• Desire to work in a fast, collaborative, team-oriented environment Strong analytical skills and experience in statistical analysis.
• Excellent written and verbal communication skills in English, including the ability to communicate effectively over teleconference and web-based meetings
• Having a comprehensive written and verbal French communication skills will be an added advantage
• Dynamic, have good interpersonal skills and are a team player
• Influence across functional areas to drive innovation and alignment.