Scientist, Analytical Development (Contract)

Scientist Analytical Development

Position Summary

We are seeking a talented and highly motivated (Scientist) Analytical Development to support analytical strategy and method development for complex therapeutic programs with an emphasis on biologics and cell and gene therapy. This individual will play a key role in developing optimizing qualifying and transferring analytical methods used to characterize product quality purity identity and stability.

The ideal candidate will have strong technical expertise in HPLC LC-MS and biophysical characterization techniques including DLS SEC-MALS and CE as well as the ability to work effectively in a cross-functional fast-paced development environment.

Key Responsibilities

• Develop optimize qualify and support transfer of analytical methods for characterization of therapeutic materials intermediates and final products
• Apply and troubleshoot analytical techniques including HPLC/UPLC LC-MS DLS SEC-MALS and CE
• Perform biophysical characterization to assess critical quality attributes such as purity aggregation size distribution molecular weight and heterogeneity
• Generate analyze interpret and clearly communicate analytical data to cross-functional teams
• Support product and process development through analytical testing for comparability formulation stability and process-related investigations
• Author and review technical documents including protocols reports method qualification summaries and development reports
• Collaborate closely with partners in process development manufacturing quality regulatory and research functions
• Support collaboration activities with external contract organizations as needed
• Maintain accurate and complete documentation in accordance with applicable quality and compliance standards. Prior experience with Electronic Lab Notebook (ELN) documentation is preferred.

Required Qualifications

• Bachelors Masters or PhD in Analytical Chemistry Biochemistry Pharmaceutical Sciences Molecular Biology or a related scientific discipline
• Relevant industry experience in analytical development pharmaceutical development biotechnology or a related field
• Strong hands-on experience with HPLC/UPLC and LC-MS including method development optimization and troubleshooting
• Prior experience with biophysical characterization techniques including DLS SEC-MALS and CE is beneficial but not required
• Demonstrated ability to interpret complex analytical data and draw scientifically sound conclusions
• Strong written and verbal communication skills with the ability to present findings clearly to technical and cross-functional audiences
• Strong organizational skills and ability to manage multiple priorities in a dynamic environment

Preferred Qualifications

• Experience supporting cell and gene therapy programs biologics or other advanced therapeutic modalities
• General knowledge of analytical considerations for complex biologics or cell and gene therapies
• Experience with analytical method qualification comparability studies stability studies and technology transfer
• Familiarity with work in regulated environments including GLP/GMP practices
• Proven ability to work collaboratively across multidisciplinary teams

Core Competencies

• Analytical rigor and scientific problem-solving
• Strong technical troubleshooting skills
• Attention to detail and commitment to data quality
• Effective cross-functional collaboration
• Clear communication and technical writing
• Ability to adapt in a fast-paced research and development environment

%60-$62/HR

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements

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