Senior Biologics Analytics Scientist (Remote)

Creative Solutions Services, LLC; San Francisco (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Creative Solutions Services, LLC in San Francisco, CA (Remote) seeks a Senior Scientist, Biologics Analytical Development to advance analytical methods and characterise biologic products. You will drive method development, perform structural and purity analyses, and support process development for microbial and mammalian systems.

The role requires leadership, collaboration across functions, and regulatory documentation contributions, with a focus on GMP-compliant workflows in a fast-paced team

Qualifications

• Minimum 5 years of experience in biotechnology or pharmaceutical industry, preferably in process development.
• Demonstrated technical creativity and independent thinking.
• Strong problem-solving, organizational, and analytical abilities.
• Excellent written and verbal communication skills.

Responsibilities

• Develop, optimize, and qualify analytical methods for biologic products.
• Characterize proteins and conjugates using LC-MS, HPLC, SEC, IEX, CE-SDS, and related techniques.
• Support upstream and downstream process development programs.
• Manage CRO/CMO activities and technology transfer.
• Review data and author/approve regulatory and GMP documentation.
• Lead projects, mentor team members, and train staff.

Skills

Analytical method development

Leadership / mentoring

Cross-functional collaboration

Problem solving

Effective communication

Tools

HPLC

CE

Mass Spectrometry

LC-MS peptide mapping

SEC

iCIEF

GMP documentation tools

Job description

Creative Solutions Services, LLC in San Francisco, CA (Remote) seeks a Senior Scientist, Biologics Analytical Development to advance analytical methods and characterise biologic products. You will drive method development, perform structural and purity analyses, and support process development for microbial and mammalian systems.

The role requires leadership, collaboration across functions, and regulatory documentation contributions, with a focus on GMP-compliant workflows in a fast-paced team