Quality Control Senior Associate Scientist I

Catalent Pharma Solutions•Kansas City, MO

1d•Onsite

About The Position

Catalent’s Kansas City (KCM) facility is a premier site for integrated drug development, manufacturing, and clinical supply services, supporting a wide range of pharmaceutical and biotech products. With cutting-edge technologies and a collaborative work environment, it offers exciting opportunities for professionals across all functions—from science and engineering to operations and logistics. The Quality Control Senior Associate Scientist I executes assigned tasks in accordance with established procedures and detailed instructions while ensuring compliance with site SXPs, corporate policies, and EHS requirements. This role applies foundational knowledge in a scientific discipline (e.g., Biology or Chemistry) to support project work within the team. The ideal candidate is self-motivated, detail-oriented, and demonstrates sound judgment in problem-solving and decision-making. This position requires the ability to work independently with minimal supervision while also collaborating effectively and supporting team members as needed.

Requirements

Bachelor's degree in related life science or physical science field with a minimum of 2 years of related work experience required, OR Master's degree in related life science or physical science field with 1 year preferred.
Experience with HPLC required (Empower preferred), with prior GMP experience strongly desired.
Ability to process, maintain, interpret, and analyze data, with a basic understanding of instrument operation and troubleshooting across multiple techniques.
Strong written and verbal communication skills, with the ability to proactively identify and communicate barriers to management and effectively resolve challenges with minimal guidance.

Responsibilities

Execute testing procedures for the identification and characterization of raw materials, stability, and drug products. Techniques include, not limited to: HPLC, GC, Karl Fischer, particle size, ICP-MS, FT-IR, and dissolution.
Execute laboratory work plan / schedule developed with input from supervisor or senior team member.
Maintain high quality documentation in accordance with applicable regulatory guidance and site SOPs documenting work as appropriate within notebooks, forms, etc.
Execute procedures or methods of moderate and advanced complexity with high quality and reviews own work to ensure accuracy and completeness.
Able to identify and remediate minor quality/compliance gaps during lab work with little guidance.
May develop/validate methods of moderate and advanced complexity.
Draft technical documents such as methods, specifications, and/or certificates of analysis with little to no guidance from a supervisor or senior team member.
May participate in or draft events, deviations, and/or investigations.
Perform peer review of routine laboratory documentation.
May review technical documents for accuracy, thoroughness, and regulatory compliance.
Trains others on procedures and lab techniques.
Assist in the execution of efficiency/compliance improvement projects with guidance
All other duties as assigned