Scientist I

Catalent•Kansas City, MO

7d•Onsite

About The Position

Catalent’s Kansas City facility supports Oral & Specialty Drug Delivery, Biologics Analytical Services, and Clinical Supply Services. The Scientist I joins the Biologics Department and provides and reports data required by project contracts, supports regulatory submissions, performs release and stability testing, and contributes to development projects involving large-molecule therapeutics. The position works with project milestones and site performance standards in a collaborative environment focused on quality, innovation, and scientific excellence. The role performs laboratory testing for in-process, release, and stability samples in support of Chemistry, Manufacturing, and Controls (CMC) activities. Work is conducted under current Good Manufacturing Practice (cGMP) standards. The Scientist I may lead projects technically, interact with customers, supervise technical staff, manage assignments and performance, and train or mentor colleagues. The position is based onsite in Kansas City, Missouri, Monday through Friday, 8:00 a.m. to 5:00 p.m.

Requirements

Bachelor’s degree, with 7 or more years of relevant experience preferred or based on performance at Catalent; or a master’s degree, with 2 or more years preferred or based on performance at Catalent; or a doctorate, with 0 or more years preferred or based on performance at Catalent.
Knowledge of relevant techniques such as mammalian cell culture, sterile technique, in vitro cell-based assays, ELISA, qPCR, PCR, BLI or SPR kinetic binding assessment, 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 organization, multitasking, time-management, and deadline-management skills, including the ability to work under pressure.
Ability to walk, sit, and stand; use hands to handle or feel; reach at or above shoulder height and below waist height; climb or balance; stoop, kneel, crouch, or crawl; talk and hear; smell; and lift up to 40 pounds during an average 8-hour day.
Specific vision abilities include frequently reading written documents, visually inspecting materials, and using a computer monitor.
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 for Chemistry, Manufacturing, and Controls (CMC) support.
Apply laboratory techniques including mammalian cell culture, sterile technique, in vitro cell-based assays, ELISA, qPCR, PCR, BLI or SPR kinetic binding assessment, 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, with responsibility for project outcomes and customer interaction.
Execute efficiency-improvement projects with guidance and identify business opportunities on a project basis.
Organize and manage teams addressing laboratory issues or special projects.
Recognize unmet customer needs and propose solutions.
Back up the supervisor in addressing technical or business issues.
Manage personal and team time and efficiency; multitask and meet deadlines under pressure.
May publish or present externally.
Perform other duties as assigned.