Job Title: Scientist - Bioassay

Job Description

The Scientist will support the Quality Control Method Transfer and Validation team by performing method validation activities, including drafting protocols and reports, executing validation assays, and conducting data analysis. The role also involves procedural updates, reviewing reports, and ensuring data integrity in accordance with cGMP principles.

Responsibilities

• Independently conceptualize, plan, and execute laboratory experiments.
• Collaborate with colleagues and subject matter experts to determine suitable analytical methodologies, utilizing computational predictive tools, modeling software, and data visualization tools.
• Lead and manage multiple projects, assisting teams in developing effective strategies for analytical needs and controls.
• Engage with the method development team and participate in in-process and final product sample analyses.
• Author relevant sections of technical reports to support interdepartmental technology and method validation and transfer processes.
• Prepare technical reports, critically review data, and evaluate new instrumentation and analytical techniques.
• Independently analyze experimental data and provide conclusive insights.
• Mentor junior scientists and offer technical guidance.
• Support technical leads and the Scientist with project activities to meet deadlines.

Essential Skills

• Experience with GMP, ELISA, Slot BLOT, Spectramax, and Nephelometry.
• Capability to independently execute laboratory assays and draft protocol deviations under supervision.
• Proficiency in performing data reviews.

Additional Skills & Qualifications

• Bachelor's, Master's, or PhD in pharmaceutical chemistry with applicable relevant experience.
• Experience in assay development, method validation, method development, method transfer, cGMP, and quality control.
• Familiarity with LIMS and immunoassays.

Work Environment

This role is set in a large pharmaceutical manufacturing organization focused on vaccine and mAb intermediate manufacturing. The work will be conducted in both office and lab environments, following a 1st Shift schedule from Monday to Friday, 8 AM to 5 PM, with occasional weekend work on a rotating basis.