What are the responsibilities and job description for the Scientist Consultant III position at Advanced Clinical?
Scientist Consultant III - Biologics Analytical Development
Location: Remote
Position Type: Full-Time, Contract
Department: Quality Control / Analytical Services
Position Overview:
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.
