Scientist – Process Development, Downstream

Catalent Pharma Solutions; Madison (WI); Presencial; USD 110.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Day-one medical, dental, and vision

401(k) with company match

Tuition reimbursement

Generous paid time off and holidays

Professional development opportunities

Descripción de la vacante

Catalent Madison is seeking Scientists, Process Development – Downstream to advance purification process development for biologics. You will independently perform downstream purification experiments, optimize processes for mAbs and bispecific constructs, and serve as technical lead on client development and transfer projects.

You will author GMP‑compliant documents, analyze complex data, and mentor junior staff, collaborating across functions in a fast-paced, onsite environment at the Madison

Formación

• Bachelor’s degree in STEM with 6+ years relevant experience or Master’s with 3+ years; PhD with relevant academic experience.
• Hands-on experience with process-scale chromatography and filtration (chromatography, tangential flow filtration, normal flow filtration).
• Experience operating ÄKTA platforms and chromatography workstations.
• Knowledge of protein purification principles, scale-up concepts, and chromatography modes.
• Strong GDP, aseptic techniques, and technical document authoring (protocols, SOPs, batch records).
• Ability to design, execute, analyze, and troubleshoot complex lab experiments under accelerated timelines.
• Proficiency with Microsoft Office and lab software systems.

Responsabilidades

• Independently perform downstream purification experiments, including automated chromatography, filtration, and TFF/DF.
• Lead the design, optimization, and characterization of downstream purification operations for mAbs and bispecific constructs.
• Serve as technical lead for client development or transfer projects and communicate results clearly.
• Author, review, and maintain GMP‑compliant documents and batch production records.
• Mentor junior team members and analyze complex data to drive process improvements.

Conocimientos

Lab purification

Chromatography

TFF/UF/DF

GDP & GMP

Data analysis

Technical writing

Mentorship

Cross-functional

Educación

Bachelor's degree in STEM

Master's degree

PhD

Herramientas

ÄKTA platforms

Descripción del empleo

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.

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: 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: Lead the design, optimization, and characterization of downstream purification operations (including chromatography, depth filtration, and UF/DF) for monoclonal antibodies (mAbs) and bispecific constructs across the full product lifecycle.
• 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 responsibilitiesas 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.

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

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