Senior Scientist, Biologics Drug Product Development

BioCT Innovation Commons; New Haven (CT); On-site; USD 120,000 - 170,000; Full time

Job summary

BioCT Innovation Commons in New Haven, CT invites a Senior Scientist to lead research, design and execute studies for parenteral biologics DP process development, characterization, and commercial validation. You will oversee manufacturing unit operations from DS freeze/thaw to DP filling, ensuring cGMP compliance and state-of-the-art biopharmaceutical analysis.

The role requires strong collaboration across Analytical Development, QA, and Regulatory, with hands-on lab work and data-driven

Qualifications

• PhD in chemistry/biochemistry/biophysics/chemical engineering or related field with 2+ years' experience.
• Hands-on biotherapeutics drug product development experience.
• Familiar with cGMP and quality systems.
• Experience transferring processes across sites.
• Ability to work in cross-functional teams and meet timelines.

Responsibilities

• Lead drug product development teams with cross-functional stakeholders.
• Design and execute development studies and support technology transfer.
• Prioritize tasks and lead project teams.
• Perform in-depth data analysis and author technical reports for regulatory filings.
• Stay current with literature and regulatory expectations.
• Communicate effectively with peers and management; present at meetings.

Skills

Protein biochemistry

Drug product process development

cGMP compliance

Data analysis

Collaboration

Technical writing

Project leadership

Education

PhD in Chemistry, Biochemistry, Biophysics, Chemical Engineering or related field

MS in a relevant field

BS in a relevant field

Tools

EndNote

GraphPad

JMP

Visio

Adobe Pro

Job description

BioCT Innovation Commons in New Haven, CT invites a Senior Scientist to lead research, design and execute studies for parenteral biologics DP process development, characterization, and commercial validation. You will oversee manufacturing unit operations from DS freeze/thaw to DP filling, ensuring cGMP compliance and state-of-the-art biopharmaceutical analysis.

The role requires strong collaboration across Analytical Development, QA, and Regulatory, with hands-on lab work and data-driven