Scientist, Tech Ops (Analytical Testing)

Scientist, Tech Ops (Analytical Testing)

The Bern Analytical Testing (BAT) Team in the Technical Operations Department, is currently looking for a Scientist with a solid understanding of biological and chemistry analytical method principles and with relevant experience in analytical method optimization & transfer and data analysis.

This is a great opportunity to work in a collaborative, agile and flexible team. Scientific enthusiasm, creativity, hands-on experience on analytical (bio-)chemistry method and commitment will be essential for the successful achievement of team and organizational goals and timelines.

Researches and develops new medicines for unmet medical needs through innovative medical science from inception, through clinical trials to commercialization. Assesses, monitors and ensures products meet clinical safety standards. Conducts sophisticated analysis, manages research information systems and technical documentation. May be involved in providing para-professional laboratory support for product testing after collection. Establishes relationship with regulatory authorities to establish and maintain registration licenses to sell products globally.

Designs and implements business experimental processes to enable product research and development. Designs related integrated process and candidate / product team activities and directs technical and operational activities to ensure planned project outcomes, and enables portfolio prioritization, resource allocation, and risk management. Provides and contributes to project progression and reports, as required, to project or program committees for decision-making support. Leads teams in the development of program and project strategy, and lifecycle management planning. Develops systems to support dynamic portfolio management. Serves a key role in portfolio evaluation process. Drives initiatives across research and development units to create fully integrated strategies. Monitors and reports on portfolio status and proactively addresses and resolves issues. May design and develop manufacturing processes for new or existing products, taking into consideration problems inherent in the transfer of technology from research to manufacturing. Develops procedures for the economical mass production in cooperation with pilot-plant and production departments. Conducts tests and measurements throughout stages of production to determine control over applicable variables. As required, will need to operate within the current regulatory and compliance environments.

Main Responsibilities and Activities

• Contributes technology platform capabilities to team in order to achieve designated project objectives.
• Coordinates global and local research and development projects.undefined
• Manages collaboration with different CSL sites and external partners.
• Applies practical knowledge of job area typically obtained through advanced education and work experience.
• Works independently with general supervision to achieve operational targets with direct impact on departmental results.
• Problems faced are difficult but typically not complex, sometimes requiring understanding of broader set of issues.
• May influence others within the job area through explanation of facts, policies, and practices. 
• Act as Subject Matter Expert (SME) for analytical topics and provide scientific input. Provision of scientific and analytical expertise for root-cause analysis related to investigation/deviations studies, process development activities, and other studies as requested.
• Design and conduct appropriate studies to answer stakeholders’ questions. Perform data analysis, present the results, and summarize them into reports at the highest levels of scientific integrity. 
• Evaluate, optimize and implement state of the art and fit-for-purpose analytical technology to enhance sample testing efficiency. 
• Professional, flexible collaboration in cross-departmental agile project teams, locally and globally.
• Provide technical expertise and guidance to laboratory technician to achieve specified project objectives.
• Author and reviewer of technical documents, including SOPs, protocols and reports for internal and external partners. 
• Ensure full compliance with the current global and local guidance and applicable GSP / GxPs regulations.

Qualifications & Experience Requirements

• Bachelors or postgraduate degree and /or extensive experience in relevant discipline.
• Minimum 3 years' laboratory experience with training in a relevant technical discipline e.g., molecular and cellular biology, analytical biochemistry.
• Proactive, detail oriented, keen to learn, positive attitude and co-operative person with ability to multi-task and proficient at working both independently and in team environment.
• Proficient English verbal and written communication skills with ability to work independently and in a team environment. German (level B2) would be a plus.
• Hand-on experience with method optimization activities and method transfer activities (internal or external to CRO) with strong ability to capture, analyse and record scientific data accurately and reliably.
• Proven track record in and confidence in qualifying analytical assays and performing matrix assessment studies.
• Strong organisational skills to drive projects such as analytical method transfer, investigations and other studies internally and externally.
• Excellent data analysis, writing and presentation skills.
• Statistical data analysis using corresponding software, e.g. GraphPad or JMP.
• Solid understanding of electronic and computerized equipment in laboratories such as electronic lab notebook (ELN), sample track management LIMS/starLIMS, and document management systems (Veeva).