Scientist I

Pace® Analytical Services•Oakdale, MN

1d•Onsite

About The Position

The Scientist I will perform routine and complex analytical testing on pharmaceutical and biopharmaceutical samples in a GMP-compliant laboratory environment. This role contributes to the quality control and R&D efforts by executing laboratory procedures and documenting results accurately.

Requirements

Bachelor's degree in chemistry/biochemistry/chemical engineering or a closely related field; AND at least two to three (2-3) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience.
Intermediate to complex microbiological principles, practices, and techniques.
Intermediate to Complex methods to resolve microbiological problems, questions, and concerns.
Understanding of broad testing tools, equipment, and calibration.
Computer applications and systems related to the work.
Principles and practices to serving as an effective project team member.
Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
Correct business English, including spelling, grammar, and punctuation.
Performing complex to specialized professional-level Microbiology duties in a variety of assigned areas.
Laboratory experience performing and validating at least three or more of the following compendial tests. USP <51> (AET Test) <55> Biological Indicators, <60> <61>< 62> Microbial Limit Test, <71> Sterility Test, <85> Endotoxin, <787>, <788>, <789> Sub-visible Particulate Test.
Must have strong working knowledge of dilutions and how to scale methods appropriately if required.
Ability to operate and train others in analytical instruments and manufacturing equipment.
Training others in policies and procedures related to the work.
Serving as a team member and the development and management of projects.
Operating in both a team and individual contributor environment.
Interpreting, applying, and explaining applicable laws, codes, and regulations.
Preparing intermediate to complex functional reports, correspondence, and other written materials.
Using initiative and independent judgment within established department guidelines.
Using tact, discretion, and prudence in working with those contacted during the work.
Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.

Nice To Haves

Cleanroom experience preferred.

Responsibilities

Execute a variety of analytical tests on raw materials, in-process samples, and finished products using techniques such as HPLC, GC, UV-Vis, Karl Fischer, dissolution, and titrations.
Prepare and analyze samples according to established Standard Operating Procedures (SOPs) and client specifications.
Operate and maintain laboratory equipment, ensuring proper calibration and functionality.
Document all experimental data, observations, and results meticulously in laboratory notebooks and LIMS system, adhering to cGMP principles.
Perform calculations, analyze data, and interpret results, identifying and troubleshooting unexpected outcomes.
Contribute to the investigation of out-of-specification (OOS) or out-of-trend (OOT) results under the guidance of senior scientists.
Participate in method development and validation activities as directed.
Adhere to all safety regulations, laboratory hygiene standards, and quality assurance protocols.
Communicate effectively with team members, supervisors, and clients regarding project status and technical findings.
Assist in maintaining laboratory inventory and ordering supplies as needed.