Associate Scientist II

Catalent•Kansas City, MO

1d•Onsite

About The Position

Catalent’s Kansas City facility is home to its Oral & Specialty Drug Delivery, Biologics Analytical Services, and Clinical Supply Services businesses. The Associate Scientist II will join the Biologics Department and provide and report data required by project contracts, support regulatory submissions, conduct release and stability testing, and contribute to development projects. The role offers the opportunity to use advanced analytical techniques in support of large-molecule therapeutics within a collaborative environment focused on quality, compliance, and scientific excellence. The position is onsite in Kansas City, Missouri, with a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule. The scientist executes laboratory work plans and schedules with input from supervisors or senior team members, handles in-process, release, and stability samples, and performs analytical work and related documentation. The role also involves method validation or transfer under direction, cGMP activities as appropriate, documentation review, training, and guided efficiency-improvement work.

Requirements

Bachelor’s degree in life sciences, such as chemistry, biochemistry, or biology, or a closely related physical science.
Maintain high-quality laboratory documentation in accordance with regulatory guidance and site standard operating procedures.
Ability to learn and retain technical information effectively.
Proactively address work issues individually and within a team.
Ability to execute moderately complex procedures or methods with high quality.
Ability to interpret written, oral, diagram, or schedule instructions accurately.
Demonstrated mathematical and scientific reasoning ability.
Basic understanding of instrument operations and troubleshooting across multiple techniques.
Ability to identify and appropriately interpret out-of-specification data.
Strong written and verbal communication skills with internal and external customers.
Lead by example in alignment with Catalent’s values and culture.
Demonstrate leadership capabilities in a matrix environment.
Recognize unmet needs within the department.
Focus on personal time management and efficiency.
Be well organized, multitask, and meet deadlines under pressure.
Physical ability to walk, sit, and stand during an 8-hour day; use hands to handle or feel; reach with hands and arms at or above shoulder height and below waist height; climb, balance, stoop, kneel, crouch, or crawl; talk, hear, and smell; and lift up to 40 pounds.
Ability to read written documents, visually inspect materials, and frequently use a computer monitor.
May be required to use a respirator.

Nice To Haves

0–3 years of relevant experience preferred, or experience based on performance at Catalent.

Responsibilities

Execute laboratory work plans and schedules for large-molecule therapeutics with input from supervisors or senior team members.
Handle in-process, release, and stability testing samples.
Perform analytical techniques including HPLC/UPLC methods (SEC, IEX, RP-HPLC, HIC, peptide mapping, and glycan analysis), Karl Fischer, compendial assays such as appearance and pH, UV-Vis, Solo-VPE, NanoDrop, and aggregation techniques such as MFI, AUC, and SEC-MALS.
Conduct method validation or transfer activities under direction.
Perform activities under current Good Manufacturing Practices (cGMP) as appropriate.
Draft technical documents such as methods or certificates of analysis.
Review laboratory documentation for accuracy, thoroughness, and regulatory compliance.
Train others on laboratory techniques.
Assist with efficiency-improvement projects with guidance.
Perform other duties as assigned.