PLS Scientist 1 - Microbiology
About the role
Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives. This is a full-time, onsite, Microbiology Scientist 1 position located in Oakdale, MN. Make an Impact. Build a Career. Pace® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Operating across a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support centers, we partner with clients to efficiently advance programs from early development through commercialization. Our experienced industry experts and continued investment in state-of-the-art facilities reflect our commitment to quality, speed, and reliability. United by a shared purpose, we bring meaningful value to patients, healthcare professionals, and health businesses worldwide by delivering services that support a safer, healthier future. Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.
Responsibilities
- Provides complex to specialized analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing.
- Provides complex to specialized review, analysis, interpretation, and documentation of testing results.
- Analyzes and reviews complex to specialized operations, results, feedback, and related microbiology formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
- Provides training and guidance on analytical tests, methods, and instrumentation, as required.
- Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change.
- Analyzes and reviews complex to specialized operations, results, feedback, and related microbiology formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
- Assists with developing or participating in microbiology formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients.
- Develop validate and transfer analytical methods.
- Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, among others.
- Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials.
- May develop and optimize manufacturing processes for drug products.
- Ensure all activities adhere to SOP's, regulatory guidelines,