Scientist I

Catalent Pharma Solutions•Kansas City, MO

1d•Onsite

About The Position

Catalent is seeking a Scientist I to join the Biologics Department at its Kansas City facility. The position contributes to the delivery of data required by project contracts and supports regulatory submissions, release and stability testing, and development projects involving large molecule therapeutics. The role works in a collaborative environment focused on quality, innovation, and scientific excellence. The Scientist I develops and executes laboratory work to meet customer milestones and site performance standards. Work includes in-process, release, and stability samples for Chemistry, Manufacturing, and Controls (CMC) support; method validation, transfer, and development; testing under current Good Manufacturing Practice (cGMP) standards; and preparing and reviewing technical documents. The position also includes team leadership, project technical leadership, customer interaction, and efficiency improvement activities. The role is based onsite in Kansas City, Missouri, with a Monday–Friday, 8 a.m.–5 p.m. schedule. Physical requirements include walking, sitting, standing, handling and feeling objects, reaching, climbing or balancing, stooping, kneeling, crouching or crawling, talking, hearing, smelling, and lifting up to 40 pounds. Frequent visual tasks include reading documents, inspecting materials, and using a computer monitor. Respirator use may be required.

Requirements

Bachelor’s degree with 7 or more years of relevant experience preferred, or experience based on performance at Catalent; alternatively, a master’s degree with 2 or more years preferred, or a doctorate with 0 or more years preferred.
Knowledge of relevant techniques including mammalian cell culture, sterile technique, in vitro cell-based assays, ELISA, molecular biology (qPCR and PCR), kinetic binding assessment (BLI or SPR), and flow cytometry.
Familiarity with drug development milestones and their context.
Excellent written and verbal communication skills with internal and external customers.
Supervisory skills are expected for Scientists with direct reports; ability to organize and manage teams addressing laboratory issues or special projects.
Ability to recognize unmet customer needs and propose solutions.
Ability to back up a supervisor in addressing technical or business issues.
Strong time management and efficiency focus, with organization, multitasking, and deadline management under pressure.
May publish or present externally.
Ability to meet the listed physical requirements, including lifting up to 40 pounds; may be required to use a respirator.

Nice To Haves

GMP experience.

Responsibilities

Develop and execute laboratory work for large molecule therapeutics using customer milestones and site performance standards.
Work with in-process, release, and stability samples to support Chemistry, Manufacturing, and Controls (CMC).
Use techniques including mammalian cell culture, sterile technique, in vitro cell-based assays, ELISA, molecular biology (qPCR and PCR), kinetic binding assessment (BLI or SPR), and flow cytometry.
Perform method validation, transfer, and development activities as needed.
Conduct testing under current Good Manufacturing Practice (cGMP) standards.
Author and review technical documents, including protocols, test methods, reports, and certificates of analysis.
Train, coach, or mentor others on technical and professional topics.
Supervise technical staff and manage work assignments and performance.
Serve as Project Technical Lead, taking responsibility for project outcomes and customer interaction.
Execute efficiency improvement projects with guidance and identify business opportunities on a project basis.
Perform other duties as assigned.