Scientist - Process Development, Drug Substance Lifecycle

Catalent Pharma Solutions•Madison, WI

4d•Onsite

About The Position

Catalent Pharma Solutions in Madison, WI is hiring a Scientist - Process Development, Drug Substance Lifecycle. The Downstream Process Development team is responsible for the development and implementation of downstream processing methodologies and analytical procedures that can be easily transferred to the cGMP Manufacturing Team. The process characterization function within the Downstream Process Development group will be responsible for the characterization of previously developed or transferred processes heading towards commercial manufacturing.

Requirements

Experience with quality control and quality control tracking systems including change control and deviations.
Knowledge of protein purification and analysis with an in depth understanding of all modes of chromatography.
Knowledge of scale up principles with respect to purification and filtration.
Bachelor's degree in a STEM discipline and 6-9 years related experience, OR Master's degree in a STEM discipline and 3-5 years related experience, OR Doctorate Degree in a STEM discipline and 0–2 years related experience.
Knowledge of the principles of drug substance lifecycle management, particularly with respect to biologics process development and manufacturing
Experience working on late phase, process characterization, process performance qualification and commercial programs is required
Process scale chromatography and filtration (viral, chromatography, tangential flow, normal flow) experience
Operating, maintaining, and troubleshooting chromatography workstations and process skids, preferably in an industrial setting

Nice To Haves

Experience in product/process CMC life cycle management including pre-approval, launch, and post-approval stages is preferred
Viral clearance validation, process scale up, and technology transfer

Responsibilities

Update group members on background and status of client projects by giving oral updates or internal presentations.
Maintain project timelines.
Troubleshoot and problem solve in order to initiate and execute/monitor corrective actions.
Act as the technical lead for client development projects, communicate project status internally and externally, and effectively provide technical explanation/rationalization.
Critically analyze complex data, interpret and integrate experimental results with project objectives.
Drive lifecycle improvements with consideration of their impact on filing, critical attributes, and specifications.
Provide technical expertise while communicating decisions for process improvement, understanding, validation, in collaboration with Catalent personal
Train others on procedures and laboratory techniques.
Author and may approve technical documents such as protocols, test methods, test reports, certificates of analysis, and operating procedures.
Review technical documents for accuracy, thoroughness, and regulatory compliance.
Train, coach, or mentor others on technical, personal development, or business issues.
Participate in client meetings offering technical support and leading the project.
Research and develop existing and new technologies/process improvements.
Manage client projects
Write procedural SOPs, batch production records, and reports.
Accurately review batch records and other data, ensuring consistency.
Execute purification experiments including automated chromatography (AKTA platform), filtration, clarification, column packing, and tangential flow filtration independently.
Adhere to good documentation practices.
Other duties as assigned related to downstream process development activities