Biologics Scientist I: Lab Lead & cGMP Focus

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid time off

8 paid holidays

Community involvement and green Initi.

Job summary

Catalent Pharma Solutions’ Kansas City facility seeks a Scientist I to join the Biologics Department, contributing data for contracts, supporting regulatory submissions, release and stability testing, and development projects. You will work with large molecule therapeutics in a collaborative, quality-focused environment.

The role includes method validation, cGMP, documentation, training, and leadership duties as a Project Technical Lead, with opportunities to drive efficiency and client

Qualifications

• Bachelor’s Degree: 7+ years of relevant experience preferred or based on performance at Catalent.
• Master’s Degree: 2+ years of relevant experience preferred or based on performance at Catalent.
• Doctorate Degree: 0+ years of relevant experience preferred or based on performance at Catalent.
• Knowledgeable in relevant techniques such as mammalian cell culture, sterile technique, in vitro cell-based assays, ELISA assays, molecular biology (qPCR, 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 expected for Scientists with direct reports.
• Ability to organize and manage teams addressing lab issues or special projects.
• Recognize unmet customer needs and propose solutions.
• Effectively back up supervisor to address technical or business issues.
• Focus on personal and team time management and efficiency.
• Well organized with the ability to multitask and meet deadlines under pressure.
• May publish or present externally.

Responsibilities

• Develop and execute laboratory work for large molecule therapeutics using customer milestones and site performance standards.
• Work with sample types including in-process, release, or stability for CMC support.
• Apply techniques such as mammalian cell culture, sterile technique, in vitro cell-based assays, ELISA assays, molecular biology (qPCR, 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 responsible 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.

Skills

Mammalian cell culture

Sterile technique

In vitro cell-based assays

ELISA assays

Molecular biology (qPCR, PCR)

Kinetic binding (BLI or SPR)

Flow cytometry

cGMP testing

Project leadership

Technical documentation

Education

Bachelor’s Degree

Master’s Degree

Doctorate Degree

Job description

Catalent Pharma Solutions’ Kansas City facility seeks a Scientist I to join the Biologics Department, contributing data for contracts, supporting regulatory submissions, release and stability testing, and development projects. You will work with large molecule therapeutics in a collaborative, quality-focused environment.

The role includes method validation, cGMP, documentation, training, and leadership duties as a Project Technical Lead, with opportunities to drive efficiency and client