Lead Biologics Analytical Scientist - Method Validation

Slingshot Connections; Aliso Viejo (CA); Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Analytical method development

HPLC/LC-MS

Bioassays & cell-based assays

Project management

CRO/CDMO collaboration

GxP/regulatory understanding

Formation

PhD in Biochemistry/Analytical Chemistry or related

MS in Biochemistry/Analytical Chemistry

Outils

HPLC

UPLC

LC-MS

IEX-HPLC

SEC-HPLC

CE

qPCR

ddPCR

Biacore

Octet

Description du poste

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.