Associate Director: Physical & Chemical Characterization

Franklin Bio Lab; King of Prussia (PA); Sur place; USD 140 000 - 190 000; Plein temps

Avantages offerts par ce poste

401(k)

401(k) Matching

Health insurance

Vision insurance

HSA/FSA

Paid Time-Off

Company Holidays

Personal Floating Holidays

Short-Term Disability

Long-Term Disability

Life and AD&D insurance

Résumé du poste

Franklin Biolabs in King of Prussia, PA seeks an Associate Director of Physical and Chemical Characterization to lead analytical testing and method development across preclinical to late clinical stages. You will act as SME for AUC, DLS, LC-MS–based assays, ELISA, CE-SDS and SEC-MALS, guiding a cross-functional team and partnering with QA on investigations and CAPAs.

On-site role with travel. Strong regulatory knowledge (cGxP) and communication skills are essential to drive improvements and

Qualifications

• Minimum of BS/BA degree in Biology, Chemistry, or other life sciences required.
• 7-9 years of direct experience in analytical testing and method development.
• Experience managing studies performed under Good Laboratory Practices (21 CFR Part 58).

Responsabilités

• Lead a team of scientists to drive the advancement of cutting-edge research.
• Develop and implement analytical strategies for characterization.
• Act as SME for Analytical Ultracentrifugation (AUC), DLS, LC-MS–based assays, ELISA and other plate-based assays, CE-SDS and SDS-PAGE, SEC-MALS, pH and osmolality testing.
• Provide direction and guidance to team members with clear objectives.
• Collaborate with QA to lead investigations for deviations, CAPA, and change controls.

Connaissances

Analytical testing

Method development

AUC SME

DLS

LC-MS–based assays

ELISA

CE-SDS

SEC-MALS

GxP

Regulatory knowledge

Formation

BS/BA in Biology or Chemistry

Outils

AUC

DLS

LC-MS

ELISA

Description du poste

Franklin Biolabs in King of Prussia, PA seeks an Associate Director of Physical and Chemical Characterization to lead analytical testing and method development across preclinical to late clinical stages. You will act as SME for AUC, DLS, LC-MS–based assays, ELISA, CE-SDS and SEC-MALS, guiding a cross-functional team and partnering with QA on investigations and CAPAs.

On-site role with travel. Strong regulatory knowledge (cGxP) and communication skills are essential to drive improvements and