Scientist II, Cell Lab (GMP)

Discover Impactful Work

As a Scientist II you will work in a multi-functional environment supporting drug development and will collaborate in cross-functional teams. You will accomplish our mission through innovation and partnership, creative problem-solving, and use of state-of-the-art technology.

A Day in the Life

• Trains on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines.
• Performs a variety of routine to complex sample preparation and analysis procedures with minimal supervision/guidance to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.
• Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs.
• Independently troubleshoots equipment & instruments. Mentors others in troubleshooting when applicable.
• Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria.
• Performs work assignments accurately, and in a timely and safe manner.
• Independently manages QC responsibilities.
• Communicates project status to project leader and helps to identify gaps and anticipate roadblocks in project team workflow.
• Completes QA facing tasks with minimal supervisor/QA input.
• Authors low complexity quality records and participates in the OOS/OOT/Atypical investigation process.

Education

Bachelor's degree in lab sciences such as chemistry, biochemistry or similar.

Experience

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years').

Knowledge, Skills, Abilities

• Demonstrated experience with cell biology, molecular biology, and immunoassay techniques, such as cell culture, ELISA, and PCR, strongly preferred.
• Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines.
• Knowledge of applicable regulatory authority, compendia and ICH guidelines.
• Demonstrates excellent manual dexterity skills, allowing for precise and accurate work.
• Exhibits strong written and oral communication skills, facilitating effective communication within the team and with stakeholders.
• Displays exceptional time management and project management skills, ensuring efficient completion of tasks.
• Proven problem-solving and troubleshooting abilities, enabling the identification and resolution of issues.
• Capable of cross-training on sample preparation techniques with another laboratory group, enhancing versatility and collaboration.
• Thrives in a collaborative work environment, actively contributing to a cohesive and productive team.