Scientist Consultant III
Scientist Consultant III
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Job Description
Job Title: Scientist Consultant III
Job Location: Princeton NJ USA
Job Location Type: Remote
Job Contract Type: Contract
Job Seniority Level: MidSenior level
Location: Remote
Position Type: FullTime 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 latestage biologics candidates. This is an exciting opportunity to contribute to cuttingedge 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 latestage 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 nonexpert stakeholders.
- 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.
- Expertise in common analytical methods for biologics such as Size Exclusion Chromatography (SEC) Capillary Electrophoresis (CE) IsoElectric Focusing (IEF) EnzymeLinked Immunosorbent Assays (ELISA) and cellbased 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 nonexperts.
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Employment Type
Full Time
