Senior Specialist, Site Analytical Sciences

Job Description

The Site Analytical Sciences Senior Specialist supports the analytical procedure life cycle, managing method lifecycles, new method introductions, transfers, regulatory compliance, investigations, product testing, and technical rationale across separations, biochemistry, and microbiology.

Responsibilities

• Manage end to end lifecycle of analytical methods, including validation, tech transfer, and PQ for all quality equipment.
• Introduce new analytical methods and technologies and assess their implementation.
• Implement changes to existing methods and equipment, covering technical elements such as parameter and reagent changes.
• Lead and troubleshoot cross functional investigations and technical issues.
• Serve as SME for regulatory questions, audit support, reagent supply issues, and provide justifications for analytical methods and equipment.
• Conduct technical reviews of impacts on methods and equipment for new or revised global test methods and compendia changes.
• Support IQ, OQ, and PQ activities for capital projects.
• Train end users in quality control and manufacturing, and provide training to site analytical sciences personnel.
• Lead and support laboratory investigations, including non execution related investigations.
• Author technical documentation for investigations and regulatory responses.
• Assess analytical impacts for QC lab operations change controls and final compendial changes.
• Develop and own change control processes for new analytical methods.
• Monitor routine assays and manage lifecycle of analytical methods to support digital method development.
• Drive continuous improvement culture using Six Sigma tools.
• Coach and train the Analytical Sciences group, modeling leadership and building a high performance organization.

Qualifications

• PhD with 3 years of experience in biopharmaceutical or pharmaceutical industry OR Master's degree with 6 years of experience.
• Hands on experience with HPLC, electrophoresis, immunoassays, bioassays, PCR, and microbiological or cell based assays.
• Proven ability to manage multiple priorities and projects independently.
• Strong communication and project management skills, with the ability to influence colleagues at all levels.
• Problem solving mindset with sound, risk based decision making.
• Passion for coaching and developing others.

Preferred Skills

• Adaptability, analytical method transfer, coaching, collaboration, communication, compliance awareness, problem solving, project management, quality awareness, technical writing.

Benefits

• Hybrid working model with flexibility for office based colleagues worldwide.
• Opportunities for professional development and continuous improvement.

Equal Opportunity Employer

We are a proud equal opportunity employer that embraces the value of diverse, talented, and committed people working together.