Scientist, Analytical Development

Job Description

Scientist, Analytical Development

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.

• 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.

• Bachelor’s, Master’s, 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 hand-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

• 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

• 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 law.

No C2C or Third-Party Vendors