Senior Scientist, Biologics

Slingshot Connections; Aliso Viejo (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Slingshot Connections is seeking a Sr. Scientist II, Biologics to lead hands-on analytical method development, validation, and testing for large molecule drug development.

You will support cross-functional teams and external partners from early clinical stages through commercialization. The role requires a PhD with 8+ years (or MS with 10+ years) in relevant fields and extensive experience with HPLC/UPLC/LC-MS, biological potency assays, and regulatory submissions.

Qualifications

• PhD (or MS) with extensive experience in Biochemistry/Analytical Chemistry.
• 6+ years in large molecule analytical development and regulatory submissions.
• Strong hands-on experience with analytical method development for biologics.

Responsibilities

• Lead hands-on analytical method development, validation, and transfer for large molecule drug products.
• Design, conduct, and troubleshoot laboratory experiments using advanced analytical instruments.
• Develop analytical, biological potency, and cell-based assays to evaluate drug quality, stability, purity, and performance.
• Support drug development programs from early clinical stages through commercialization.
• Lead analytical investigations and independently resolve technical challenges.
• Oversee stability studies, analyze trends, and interpret experimental data.
• Coordinate analytical activities with CROs, CDMOs, and internal teams to meet project timelines.
• Serve as the analytical lead on Chemistry, Manufacturing, and Controls (CMC) project teams.
• Collaborate with protein and peptide engineering teams to support the development of novel drug formulations.
• Evaluate new analytical technologies and implement improved testing methods.
• Prepare experimental protocols, technical reports, and regulatory documentation.
• Contribute to CMC sections of INDs and NDAs and respond to regulatory inquiries.
• Support Quality Control teams with method validation, method transfers, and product specifications.
• Provide technical training, mentorship, and guidance to other scientists.
• Present findings and project updates to cross-functional teams and leadership.
• Manage multiple projects while ensuring data integrity and timely deliverables.

Skills

Analytical method development

HPLC/LC-MS

Bioassays & cell-based assays

Project management

CRO/CDMO collaboration

GxP/regulatory understanding

Education

PhD in Biochemistry/Analytical Chemistry or related

MS in Biochemistry/Analytical Chemistry

Tools

HPLC

UPLC

LC-MS

IEX-HPLC

SEC-HPLC

CE

qPCR

ddPCR

Biacore

Octet

Job description

The Sr. Scientist II, Biologics will lead hands-on analytical method development, validation, and testing for large molecule drug development while supporting cross-functional teams, external partners, and projects from early clinical stages through commercialization.

We're looking for someone who

• Holds a Ph.D. with 8+ years of experience or an M.S. with 10+ years of experience in Biochemistry, Analytical Chemistry, Immunoanalytical Chemistry, or a related scientific field
• Has 6+ years of pharmaceutical industry experience in large molecule analytical development, drug product analysis, and regulatory submissions
• Has strong hands-on experience developing, validating, and transferring analytical methods for large molecules
• Is proficient in chromatographic techniques, including HPLC, UPLC, IEX-HPLC, SEC-HPLC, and LC-MS
• Has working knowledge of analytical and bioassay techniques such as CE, cIEF, MSD, ELISA, ddPCR, qPCR, Octet, and Biacore
• Can independently design experiments, operate laboratory instruments, troubleshoot technical challenges, and lead projects
• Has experience developing biological potency assays and cell-based assays
• Understands stability studies, trend analysis, and analytical data interpretation
• Has experience working with CROs, CDMOs, and other external pharmaceutical partners
• Understands regulated environments, including GxP, ICH, and FDA requirements
• Has strong knowledge of quality systems, drug product manufacturing, validation, and regulatory submissions
• Demonstrates strong project management skills and can manage multiple priorities
• Communicates effectively and collaborates with cross-functional teams
• Has strong scientific leadership skills and can provide technical guidance to other scientists
• Is comfortable working independently in a hands-on laboratory environment

What you'll do

• Lead hands-on analytical method development, validation, and transfer for large molecule drug products
• Design, conduct, and troubleshoot laboratory experiments using advanced analytical instruments
• Develop analytical, biological potency, and cell-based assays to evaluate drug quality, stability, purity, and performance
• Support drug development programs from early clinical stages through commercialization
• Lead analytical investigations and independently resolve technical challenges
• Oversee stability studies, analyze trends, and interpret experimental data
• Coordinate analytical activities with CROs, CDMOs, and internal teams to meet project timelines
• Serve as the analytical lead on Chemistry, Manufacturing, and Controls (CMC) project teams
• Collaborate with protein and peptide engineering teams to support the development of novel drug formulations
• Evaluate new analytical technologies and implement improved testing methods
• Prepare experimental protocols, technical reports, and regulatory documentation
• Contribute to CMC sections of INDs and NDAs and respond to regulatory inquiries
• Support Quality Control teams with method validation, method transfers, and product specifications
• Provide technical training, mentorship, and guidance to other scientists
• Present scientific findings and project updates to cross-functional teams and leadership
• Manage multiple projects while ensuring accurate data, quality standards, and timely deliverables