Associate Scientist

Job Title: Sr. Associate Scientist - Plate Based

Job Description

The Associate Scientist will support the Quality Control Method Transfer and Validation team by performing method validation activities, such as drafting protocols and reports, executing validation assays, and conducting data analysis. The role requires adherence to cGMP and data integrity principles while reviewing reports and data. This is an exciting opportunity to work on high-profile projects and gain exposure to innovative methods and technologies.

Responsibilities

• Independently conceptualize, plan, and execute laboratory experiments.
• Collaborate with colleagues and subject matter experts to determine suitable analytical methodologies, using 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 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 as required.
• Independently analyze experimental data and provide conclusive insights.
• Mentor junior scientists and offer technical guidance when required.
• Support the technical leads and Sr. Scientist with project activities to meet deadlines.

Essential Skills

• Experience with GMP in a pharmaceutical lab environment.
• Proficiency in PCR or ELISA testing.
• Strong pipetting skills.
• Experience with analytical plate-based assays.
• Bachelor's degree in a life science field.
• 2+ years of experience in a pharmaceutical GMP lab.

Additional Skills & Qualifications

• Method validation and transfer experience.
• Knowledge of cGMP and quality control processes.
• Familiarity with LIMS and immunoassays.
• Experience with Spectramax and Lowry assays.

Work Environment

The position is within a large pharmaceutical manufacturing organization focused on vaccine and mAb intermediate manufacturing. The role is primarily lab-based with almost 100% of time spent in the lab. Work shifts include a Monday-Friday 8-hour shift and a Sunday-Wednesday 10-hour shift. The start time is 8:30 am, with coordination needed for any changes to the shift schedule. A tier meeting is held at 8:30 am, which is mandatory for all team members.