Downstream Process Development Scientist (Early Phase)

Catalent Pharma Solutions; Alabama; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Tuition reimbursement and professional

Job summary

Catalent is seeking Scientists, Process Development – Downstream to support the development, optimization, characterization, and transfer of purification processes for biologics manufacturing. Location is onsite at Catalent Madison, WI, with focus on early‑phase process development and technology transfer to cGMP manufacturing.

Ideal candidates will have hands-on chromatography and filtration experience, strong data analysis and technical writing skills, and the ability to lead client projects

Qualifications

• Bachelor's degree in a STEM discipline with a minimum of 6 years relevant experience, Master's degree with a minimum of 3 years relevant experience, or PhD with relevant academic experience.
• Hands-on experience with process-scale chromatography and filtration (chromatography, tangential flow filtration, normal flow filtration).
• Experience operating, maintaining, and troubleshooting chromatography workstations and process skids (e.g., ÄKTA platforms).
• Demonstrated knowledge of protein purification principles, methods, scale-up concepts, and modes of chromatography.
• Strong working knowledge of GDP, aseptic techniques, and technical document authoring (protocols, SOPs, batch records, reports).
• Ability to independently design, execute, analyze, and troubleshoot complex laboratory experiments under accelerated timelines.
• Proficiency with Microsoft Office applications (Excel, Word) and laboratory or manufacturing software systems.

Responsibilities

• Laboratory Execution: Independently perform downstream purification experiments, including automated chromatography (ÄKTA platforms), filtration, clarification, column packing, and tangential flow filtration (TFF/UF/DF).
• Process Development & Optimization (Early-Phase Focus): Develop and optimize novel downstream purification methodologies, applying platform concepts and screening techniques to establish robust early‑stage processes for client candidates.
• Tech Transfer & Scale-Up (Tech Transfer Focus): Lead technology transfer activities into cGMP manufacturing, executing scale-up studies, process characterization, viral clearance validation, and pilot‑scale non‑GMP engineering runs.
• Technical Leadership & Client Interaction: Serve as technical lead for client development or transfer projects, effectively communicating project status, technical rationales, and experimental results internally and externally.
• Documentation & GMP Compliance: Author, review, and maintain GMP‑compliant technical documents—including protocols, SOPs, test reports, and batch production records (BPRs)—in accordance with GDP.
• Data Analysis & Mentorship: Critically analyze complex experimental data using sound scientific judgment, while helping train, coach, and mentor junior team members on laboratory procedures.
• Other responsibilities as needed.

Skills

Downstream purification

Data analysis

Technical writing

Cross-functional collaboration

Chromatography

TFF/DF

Education

Bachelor's degree in STEM

Master's degree

PhD

Tools

ÄKTA platforms

GMP documentation systems

Job description

Catalent is seeking Scientists, Process Development – Downstream to support the development, optimization, characterization, and transfer of purification processes for biologics manufacturing. Location is onsite at Catalent Madison, WI, with focus on early‑phase process development and technology transfer to cGMP manufacturing.

Ideal candidates will have hands-on chromatography and filtration experience, strong data analysis and technical writing skills, and the ability to lead client projects