Biologics Process Development Scientist – Cell & Assay Expert

BioSpace; Cambridge (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Life and disability insurance

Flexible spending accounts

Bonus program

Stock-based incentives

Paid time off

Flexible work model

Job summary

Amgen is seeking a Process Development Associate Scientist in Cambridge, MA. You will develop and transfer analytical potency and biological characterization assays, supporting sample testing and regulatory submissions.

The role requires Masters or Bachelors with relevant experience in cell culture, bioassay development, and analytical science. You will collaborate with cross-functional teams, generate data, and contribute to technical reports and project milestones while maintaining rigorous

Qualifications

• Masters degree and 1 year of scientific experience
• OR
• Bachelor's degree and 3 years of scientific experience
• Expertise in cell culture, and cell biology techniques for quantitative determination of biological activity of proteins
• Expertise in cell-based bioassay development (characterization methods, qualification, validation, technical transfer)
• Expertise with signal transduction, gene expression, receptor binding and fluorescent probe technologies
• Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines
• Innovation supports new ideas and initiatives
• Detail oriented and excellent documentation skills
• Experience with automated liquid handling preferred
• Client orientation establishes effective and responsive relationships with all clients; ensures value is delivered
• Communication and Interpersonal skills communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well in teams

Responsibilities

• Developing, qualifying and transferring state-of-the-art analytical potency and biological characterization assays for release testing, stability testing, product characterization, reference standard characterization, and investigations
• Assisting in the preparation of technical reports for investigations, product and impurity characterization, and regulatory submissions
• Generating and analyzing analytical data to support product development and regulatory submissions
• May contribute to analytical development teams by providing analytical updates, documentation and data interpretation; keeps current in the analytical development field

Skills

Cell culture expertise

Bioassay development

Molecular biology techniques

Analytical data analysis

Documentation skills

Regulatory submission support

Education

Master's degree in a scientific field

Bachelor's degree with 3 years experience

Job description

Amgen is seeking a Process Development Associate Scientist in Cambridge, MA. You will develop and transfer analytical potency and biological characterization assays, supporting sample testing and regulatory submissions.

The role requires Masters or Bachelors with relevant experience in cell culture, bioassay development, and analytical science. You will collaborate with cross-functional teams, generate data, and contribute to technical reports and project milestones while maintaining rigorous