Scientist Process Development, Upstream

Scientist Process Development Upstream

Catalent is seeking Scientists Process Development Upstreamto support the development optimization characterization and transfer of mammalian cell culture processes forbiologicsmanufacturing. Scientists in this role may support projects across multiple development stages including early-phase process development process characterizationvalidationreadiness and clinical/commercial manufacturing support.

Successful candidates may be assigned to different upstream development teams based on business needs and experience. Opportunities include supportofearly-stage process development programs as well as late-phase process characterization validation and commercial manufacturing initiatives.

The successful candidate will combine strong laboratoryexpertisewith 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

Catalents Madison Wisconsin facility isa state-of-the-artbiologicsdevelopment and manufacturing site supporting customers from research through early- and mid-stage clinical production. Located at 726 Heartland Trail the 102700-square-foot GMP facility specializes in mammalian cell line engineering drug substance manufacturing and biopharmaceutical process development.

The site is home to Catalents proprietaryGPEx andGPEx Lightning technologies enabling the generation of high-producing mammalian cell lines for biologic therapies. With production capabilities ranging from 50L to 4000L and a recent $45 million expansion the Madison campus continues to play a critical role in Catalents globalbiologicsnetwork while supporting Wisconsins growing life sciences industry.

Location:100% Onsite at our facility in Madison Wisconsin
Shift:Monday Friday First Shift

Key Responsibilities

• Design and execute upstream process development studies supportingbiologicsprograms from early development through commercial readiness.

• Perform mammalian cell culture activities including cell bank thawing seed train expansion bioreactor operations and analytical testing.

• Support process optimization process characterization scale-upvalidationreadiness and technology transfer activities using platform methods and statistical tools including Design of Experiments (DOE).

• Analyze experimental data and communicate results through presentations technical recommendations and project updates.

• Maintain GMP-compliant documentation and author or review technical documents including protocols reports SOPs and regulatory-supporting documentation.

• Serve as a technical resource for internal teams and external clients by communicating project progress presenting results and supporting project execution.

• Contribute to continuous improvement initiatives laboratory operations and the training and mentoring of junior team members.

• Other responsibilities as needed.

Required Qualifications

• Bachelors degree in a STEM discipline with a minimum of 6 years relevant experienceMastersdegree with a minimum of 3 years relevant experience or PhD with relevant academic experience.

• Experience with upstream process development mammalian cell culture bioreactor operations or relatedbiologicsdevelopment activities.

• Ability to independently design execute analyze and troubleshoot complex experiments in a fast-paced environment.

• Strong understanding of GMP documentation practices data integrity requirements and technical writing including protocols reports and SOPs.

• Demonstrated analytical and problem-solving skills with the ability to interpret dataidentifyprocess improvements and recommend technical solutions.

• Proficiencywith Microsoft Office applications and laboratory or manufacturing software systems.

Preferred Qualifications

• Experience in upstream biologics process development process characterization or process optimization.

• Experience with technology transfer validation support scale-up or commercial manufacturing programs.

• Working knowledge of statistical analysis tools and Design of Experiments (DOE).

• Experience with automated small-scale bioreactor systems such asAmbr 250or similar technologies.

• Experience authoring technical reports protocols and regulatory-supporting documentation.

• Experience in a GMP-regulated biopharmaceutical biotechnology or CDMO environment.

• Previousclient-facing experience.

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 companymatch.

• 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.