Associate Scientist II

Catalent Pharma Solutions•Kansas City, MO

2d•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 joins the Biologics Department and provides and reports data required by project contracts, supports regulatory submissions, and performs release and stability testing and development projects. The role works with advanced analytical techniques and large molecule therapeutics in a collaborative environment focused on quality, compliance, and scientific excellence. The position is 100% onsite in Kansas City, Missouri, with a Monday–Friday schedule from 8:00 a.m. to 5:00 p.m. The scientist executes laboratory work plans and schedules with input from supervisors or senior team members, performs work under current Good Manufacturing Practices as appropriate, and contributes to technical documentation, training, and efficiency improvements.

Requirements

Bachelor’s degree in life sciences, such as chemistry, biochemistry, or biology, or in 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.
Execute moderately complex procedures or methods with high quality.
Interpret written, oral, diagram, or schedule instructions accurately.
Demonstrate mathematical and scientific reasoning ability.
Basic understanding of instrument operations and troubleshooting across multiple techniques.
Identify and interpret out-of-specification data appropriately.
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, able to multitask, and able to meet deadlines under pressure.
Physically able 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.
Meet specific vision requirements, including reading written documents, visually inspecting materials, and frequently using 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 (SEC, IEX, RP-HPLC, HIC, peptide mapping, and glycan analysis), Karl Fischer, compendia assays such as appearance and pH, UV-Vis, Solo-VPE, Nano Drop, 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 under guidance.
Perform other duties as assigned.