Research Scientist I

As a Research Scientist I, you will be responsible for performing analytical testing with minimal assistance, demonstrating technical knowledge to troubleshoot problems and handle non-routine situations, assisting and mentor other team members, and embracing accountability for deliverables and leading team discussions/initiatives. While you will primarily support stability testing, you may also support new product development and/or sustaining product initiatives.

What you'll be doing

• Conduct critical chemical and physical analyses on finished product stability samples.
• May also support testing of raw materials, initial, in-process, and final product samples from manufacturing facilities or department projects.
• Work under minimum supervision.
• May act as a study director for studies, supervisor for testing exceptions and owner for laboratory investigation.
• Independently evaluate results and impact to studies/laboratory.
• May provide training and supervision to junior members within the laboratory.
• Routinely provide advice and assistance to team members regarding unique problems.
• Perform review of test data, which includes overall documentation practices.
• Perform review functions in LIMS or other computerized systems.
• Perform advanced chemical assays requiring precise analytical skills and understanding of chemistry principles.
• Complete all testing, including special project / protocol testing in a timely and appropriate manner to meet project schedules.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, cGxP, and QSR regulations.
• Collaborate with other functions/departments to solve problems, increase efficiency, improve quality and provide product support.
• Influence program, project and/or functional leadership and cross-functional teams.
• Proposes and drives solutions to complex technical problems in area of expertise.
• Maintain laboratory safety requirements, perform equipment maintenance/calibration, and troubleshoot instrumentation.

What you'll bring

• Bachelors degree in relevant scientific discipline (e.g. chemistry, pharmaceutical sciences) with at least 5+ years' experience or 3+ years' experience with a Masters degree.
• Analytical chemistry instrumentation experience (e.g. HPLC, UPLC, pH, KF, etc) and MS experience is preferred.
• Must have HPLC/UPLC/UHPLC experience in a regulated environment and strong technical problem-solving skills.

Preferred skills

• Experience with Biosimilars and associated analytical techniques is desired
• Electronic Lab Notebook experience is preferred.
• Pharmaceutical GMP laboratory experience is desired.
• Empower experience required.
• Custom fields experience is desired.
• Stability study execution and/or method validation experience is desired.
• Must demonstrate effectiveness in ability to train others, leadership, organization, teamwork/interpersonal skills, results orientation, and task completion.
• Must be able to handle multiple tasks concurrently and in a timely fashion.
• Possess relevant laboratory/technical, writing, and computer skills.