ANALYTICAL SCIENTIST (PLATE BASED ASSAYS)

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 and procedural updates. Additionally, the Scientist will review reports and data in accordance with cGMP and data integrity principles.

ESSENTIAL SKILLS

• Experience with GMP, Anthrone, Spectramax, and ELISA.
• Bachelors, Masters, or PhD in pharmaceutical chemistry with applicable relevant experience.
• Capability to independently execute laboratory assays, draft protocol deviations under supervision, and perform data reviews.

ADDITIONAL SKILLS & QUALIFICATIONS

• Experience in assay development, method validation, method development, and method transfer.
• Knowledge of cGMP, quality control, LIMS, and immunoassays.

RESPONSIBILITIES

• Independently conceptualize, plan, and execute laboratory experiments.
• Collaborate with colleagues and subject matter experts to determine the most suitable analytical methodologies to support project initiatives, utilizing computational predictive tools, modeling software, and data visualization tools as necessary.
• 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 both 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/approaches as required.
• Independently analyze experimental data and provide conclusive insights.
• Mentor junior scientists and offer technical guidance when required.
• Support the technical leads and the Sr. Scientist with project activities to meet deadlines.

available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave