Principal Scientific Associate (dissolution expertise)

Exciting new role at one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

Headquartered in Basel, Switzerland - a European biotech hub – Our client is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options.

For the Analytical Development and Quality Control Department, we are seeking a Principal Scientific Associate specialized in Dissolution Testing:

Job Responsibilities:

• Performing Dissolution experiments in the laboratory
• Project management responsibilities regarding Analytical CMC
• RA Documentation support regarding Analytical CMC
• Organization of laboratory activities. Follow the processes defined in Guidelines and SOP’s
• Development, optimization and implementation of analytical methods, e.g., for purity-, stability-, cleaning verification/validation-, excipients-, content-, and potentially genotoxic impurity determinations
• Write-up of analytical methods for implementation
• Participation and collaboration in meetings at intra- and inter-departmental level (e.g., CMC)
• Conduct of release, retest, stability studies, transfer and validation analyses
• Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g. notebooks, raw data hardcopies)
• Review, interpretation and documentation of analytical protocols and reports, e.g. for validation and stability studies
• Assurance of adequate maintenance and operation of analytical equipment according to GMP
• Drafting and review of CoAs and/or Analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs
• Organization of GMP-(re)qualification and validation of analytical equipment with external companies
• Elaboration of qualification plans and review of qualification documents
• Training of Laboratory personnel on advanced tasks and GMP regulations
• Ensuring of cleanliness of laboratory and workspace
• Independently designs and executes projects or experiments with hands on involvement 
• Independently reviews scientific work in project related activities
• Ensures availability of adequate lab materials as well as justifies acquisition of new materials or equipment
• Contact for 3rd parties, e.g., CMOs and CROs for defined analytical tasks
• Independent evaluation and development of novel analytical techniques and instrumentation
• Leverages workload of respective project members to assure timelines and budget are met
• Review CMC sections for INDP/IMPD and NDA/MAA filings
• Design and perform laboratory work to support product or process troubleshooting, special investigations, CAPA and product complaints with minimal supervision
• Set and accomplish product development timelines working closely with formulation scientist

Ideal candidate:

• Apprenticeship-, College-, or university-degree or equivalent education in the field of chemistry, biology, biochemistry, pharmacy, or chemical engineering
• Apprenticeship 11+ years, BS 9+ years or MS 6+ years or PHD 0-2 years ‘experience
• Ability to efficiently plan and effectively execute and document analytical experiments in a GMP-compliant pharmaceutical environment
• Good Knowledge of analytical chemistry with advanced knowledge of sample preparation, HPLC and spectroscopic instrumentation
• Good trouble-shooting skills for analytical analyses
• Good knowledge of GMP
• High flexibility, advanced communication, time-management and team-working skills
• Ability to work independently and to take initiative
• Life-long learning mindset and strong sense of accountability
• Should actively seek for technical solutions to improve quality and productivity
• Proficient in English
• Project management experience
• PK/PD Modeling knowledge desirable

Please apply!