We are seeking a highly skilled Scientist Consultant (QC/AS) III to join our team in support of late-stage biologics candidates. This is an exciting opportunity to contribute to cutting-edge work in biologics analytical development. The ideal candidate will have a strong background in analytical chemistry and biologics, with experience in working with CROs/CDMOs to coordinate analytical testing and support method transfers. The role will also involve authoring/reviewing analytical methods and protocols, evaluating method validations, and supporting regulatory submissions.

Key Responsibilities:

• Support analytical activities for late-stage biologics candidates.
• Coordinate with CROs/CDMOs for analytical testing and provide support as needed.
• Author and review analytical methods, protocols, and standard operating procedures (SOPs).
• Facilitate method transfers to CROs/CDMOs and ensure alignment with regulatory requirements.
• Evaluate analytical method validations and contribute to the optimization of methods.
• Interface with regulatory teams to support the authoring/reviewing of analytical sections for Biologics License Applications (BLAs).
• Effectively communicate core principles of common biologics analytical methods to non-expert stakeholders.

Basic Qualifications:

• Bachelor’s Degree in Biochemistry, Molecular Biology, or a related scientific field with at least 8 years of industry experience.
• Master’s Degree in Biochemistry, Molecular Biology, or a related scientific field with at least 6 years of industry experience.
• Ph.D. in Biochemistry, Molecular Biology, or a related scientific field with at least 4 years of industry experience.

Preferred Qualifications:

• Expertise in common analytical methods for biologics, such as Size Exclusion Chromatography (SEC), Capillary Electrophoresis (CE), IsoElectric Focusing (IEF), Enzyme-Linked Immunosorbent Assays (ELISA), and cell-based assays.
• Strong understanding of regulatory requirements for biologics and experience working with regulatory teams.
• Excellent written and verbal communication skills with the ability to explain complex scientific concepts to non-experts.