Scientist – Process Development, Downstream

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

Scientist – Process Development, Downstream

Scientist – Process Development, Downstream Catalent is seeking Scientists, Process Development – Downstream to support the development, optimization, characterization, and transfer of purification processes for biologics manufacturing. We are currently hiring for opportunities focused on Early‑Phase Process Development, as well as Technology Transfer & Scale‑Up Support. Candidates will be evaluated for the team alignment that best matches their background and career goals. Scientists in this role combine strong laboratory expertise in protein purification with data analysis, technical problem‑solving, technical writing, and cross‑functional collaboration to deliver high‑quality process solutions for internal and client programs.

About Catalent Madison

About Catalent Madison: Catalent's Madison, Wisconsin facility is a state‑of‑the‑art biologics development and manufacturing site supporting customers from research through early‑ and mid‑stage clinical production. Located at 726 Heartland Trail, the 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance manufacturing, and biopharmaceutical process development. The site is home to Catalent's proprietary GPEx® and GPEx® Lightning technologies, enabling the generation of high‑producing mammalian cell lines for biologic therapies. With production capabilities ranging from 50L to 4,000L and a recent $45 million expansion, the Madison campus continues to play a critical role in Catalent's global biologics network while supporting Wisconsin's growing life sciences industry.

Location: 100% Onsite at our facility in Madison, Wisconsin

Shift: Monday – Friday, First Shift

Key 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 Good Documentation Practices (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.

Required 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 Good Documentation Practices (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.

Preferred Qualifications

• Experience in early‑stage biologics process development, clone/candidate screening, method adaptation, or process optimization.
• Direct experience with technology transfer into cGMP manufacturing, scale‑up parameters, viral clearance validation, or process characterization.
• Experience in a cGMP‑regulated biopharmaceutical, biotechnology, or CDMO environment.
• Experience using quality systems for tracking deviations, investigations, and change controls.
• Demonstrated experience mentoring and training junior scientific staff.
• Excellent client‑facing and communication skills, with experience leading technical project discussions and client updates.

Why you should join Catalent

• Opportunity to play a key role in driving growth within a global CDMO leader.
• Competitive compensation package, including incentive opportunity.
• Day‑one medical, dental, and vision coverage.
• 401(k) with company match.
• Tuition reimbursement and professional development opportunities.
• Generous paid time off and holiday schedule (152 hours + 8 holidays).
• Collaborative, mission‑driven culture focused on improving patient outcomes worldwide Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world.
• Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time‑tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.