Testing Coordinator/Research Associate III

$96,000 - $132,000/Yr

Baxter International - Minneapolis, MN

Full-time - Mid Level

Minneapolis, MN

Miscellaneous Manufacturing

About the position

The Stability Study Coordinator will play a crucial role in the Renal Solutions and Containers - Analytical Chemistry and Stability team at Vantive, supporting Renal Care and Acute Therapy R&D projects. This position focuses on operational excellence and continuous improvement, streamlining processes, coordinating with various stakeholders, and ensuring the establishment of shelf life for new and existing products. The successful candidate will leverage their technical knowledge to contribute to multiple projects while fostering innovation and process improvement.

Responsibilities

• Process inputs from Global Stability Functional Leader and Stability SMEs to resolve schedules and forecast resource allocations to projects.
• Ensure the right methods and specifications are available for stability testing.
• Coordinate testing with global teams and CROs as applicable.
• Interact with other testing groups (Particle, Sterility/BET, etc.) to resolve schedules and alignment with business needs/function commitments.
• Collaborate with other functions such as project management, regulatory, extractables, manufacturing and quality in project teams.
• Participate in detailed planning of Registration Stability Test lab, and if approved, lead the implementation.
• Participate in investigations that correspond to atypical or out-of-specification/out-of-trend results.
• Review data and author technical evaluations that characterize the stability trending of suspect data.
• Leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles.
• Create, update, and maintain equipment and analytical procedures.
• Independently plan, implement, and lead projects/programs that both span multiple subject areas and use established methods, techniques, or approaches.
• Provide authoritative advice and/or actively participate in the generation, review, adoption and interpretation of cGxP regulations.

Requirements

• Experience with analytical method development, validation and transfer.
• A good understanding of ICH, USP guidelines and cGxP practice.
• Experience with ICP-MS, ICP-OES, IC, AA, UHPLC/HPLC, GC, UV, Polarimeter, (NMR a plus) and other analytical instruments and software (Open Lab, ELN, Empower).
• Apply a logical, methodical approach in independently solving problems, developing solutions, and making recommendations.
• Possess basic understanding of analytical chemistry including theoretical knowledge and practical experience.
• Possess understanding of manufacturing documents.
• Possess strong time management and project management skills.
• Functional understanding of FDA, ISO and Quality systems.
• Experience working with complex databases would be a bonus.

Nice-to-haves

• Experience in cross-functional teamwork.
• Independent experimentation in method development and validation.

Benefits

• Flexible workplace policy allowing a minimum of 3 days a week onsite.
• Discretionary bonuses may be available.
• Equitable pay practices and transparency in compensation.