Senior Scientist, Biologics Analytical Development

Meet Life Sciences Ltd.; San Francisco (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Meet Life Sciences Ltd. in San Francisco seeks a Senior Scientist in Biologics Analytical Development to drive method development, characterization, and process support for recombinant protein therapeutics, from early research through GMP manufacturing.

The role requires a PhD and 5+ years in biotech/pharma, with hands-on experience in HPLC/UHPLC, MS-based mapping, and biophysical methods, plus CRO oversight and cross-functional collaboration.

Qualifications

• PhD in a scientific or engineering discipline.
• 5+ years in biotech/pharma, preferably biologics or process development.
• Proven experience with analytical method development and qualification for biologics.
• Hands-on protein characterization using HPLC/UHPLC, SEC, IEX, CE-SDS, iCIEF, LC-MS.
• Experience managing CROs and technology transfer.

Responsibilities

• Develop, optimize, qualify, and transfer analytical methods for biologics.
• Characterize recombinant proteins and protein conjugates using chromatographic, electrophoretic, mass spectrometry, and biophysical techniques.
• Support upstream and downstream process development programs.
• Identify, characterize, and quantify product- and process-related impurities.
• Review analytical data to support GMP manufacturing and regulatory filings.
• Manage analytical activities performed by CROs and support analytical transfers to CROs and CMOs.
• Author and review technical reports, SOPs, protocols, and scientific documentation.
• Support regulatory filings through preparation and review of CMC documentation.
• Independently design, execute, and analyze laboratory studies.
• Collaborate with cross-functional development, manufacturing, quality, and regulatory teams.
• Mentor junior scientists and provide technical leadership as needed.

Skills

PhD

Biologics experience

Analytical method development

Protein characterization

HPLC/UHPLC

SEC

IEX

CE-SDS

iCIEF

LC-MS

Process development

CRO management

Education

PhD in Life Sciences or related field

Job description

Senior Scientist, Biologics Analytical Development (Contract)

I'm partnering with an innovative biotechnology company seeking a Senior Scientist, Biologics Analytical Development to support the development of recombinant protein therapeutics through analytical method development, product characterization, and process development support. This is an exciting opportunity to contribute to biologic drug development from early-stage research through GMP manufacturing.

Requirements

• PhD in a scientific or engineering discipline (exceptional candidates with significant industry experience may be considered)
• 5+ years of biotechnology or pharmaceutical industry experience, preferably within biologics or process development
• Strong experience with analytical method development, optimization, and qualification for biologic products
• Hands‑on experience with protein characterization techniques including HPLC/UHPLC, SEC, IEX, CE‑SDS, iCIEF, LC‑MS peptide mapping, and biophysical characterization methods
• Experience supporting recombinant proteins, protein conjugates, or related biologic modalities
• Experience supporting upstream and downstream process development activities
• Experience managing analytical work at CROs and supporting technology transfer activities
• Strong scientific data analysis, problem‑solving, and technical writing skills

Responsibilities

• Develop, optimize, qualify, and transfer analytical methods for biologic products
• Characterize recombinant proteins and protein conjugates using chromatographic, electrophoretic, mass spectrometry, and biophysical techniques
• Support upstream and downstream process development programs
• Identify, characterize, and quantify product- and process-related impurities
• Review and interpret analytical data supporting process development and GMP manufacturing activities
• Manage analytical activities performed by CROs and support analytical transfers to CROs and CMOs
• Author and review technical reports, SOPs, protocols, and scientific documentation
• Support regulatory filings through preparation and review of CMC documentation
• Independently design, execute, and analyze laboratory studies
• Collaborate with cross-functional development, manufacturing, quality, and regulatory teams
• Mentor junior scientists and provide technical leadership as needed

Preferred

• Experience working in an FDA-regulated environment
• Strong knowledge of GMP requirements and laboratory practices
• Experience supporting regulatory submissions and CMC documentation