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. This role will manage the lifecycle of drug substance programs as they progress though the development, validation, and manufacturing phases into late stage. This person will be the lead interdisciplinary Subject Matter Expert as a program moves to and through commercialization, including key technical support during regulatory agency inspections and queries, process characterization, process validation, and commercial program maintenance (e.g., Annual Product Reports [APRs], data trending/analysis). The candidate will provide general program oversight, coordinate the analysis and trending of analytical data, and provide technical input for protocols, reports, deviation investigations and / or process improvements. This position will be client-facing and require the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.

Requirements

Ph.D. in STEM, or related field with at least 8 years of biopharmaceutical process development or manufacturing experience OR MS in STEM, or related field with at least 12 years of biopharmaceutical process development or manufacturing experience OR B.S/B.A. in STEM, or related field with at least 15 years of biopharmaceutical process development or manufacturing experience.
Demonstrated excellence in prior roles can be a substitute for the minimum years of experience.
Knowledge of the principles of drug substance lifecycle management, particularly with respect to biologics process development and manufacturing is required.
Successful experience interacting and liaising with internal and external clients, customers, and / or suppliers is required
Experience working on late phase, process characterization, process performance qualification and commercial programs is required.
Knowledge and experience working in biologics process development and supporting cGMP manufacturing is required.

Nice To Haves

Experience in product / process CMC life cycle management including pre-approval, launch and post-approval stages is preferred.

Responsibilities

Work cross-functionally with Manufacturing Sciences and Technology, Manufacturing, Quality Assurance, Quality Control, Project Management, and other departments to ensure the success of a molecule’s lifecycle, including cross-site project management and coordination.
Author and review process characterization protocols and reports.
Own the process knowledge of the biologic product throughout the development and validation lifecycles; perform data analysis of historical batches to drive process characterization experimental design.
Maintain oversight of the process capability through data trending and statistical analysis of critical variables; ensure processes are robust, in a continued state of validation, and continuously improving.
Prepare and review content for client meetings with a focus on data analysis and adherence to program timelines.
Provide technical leadership on strategic initiatives including tech transfers, process characterization, process validation, technical reports, data analysis, process monitoring, product comparability, and second line support of technical/scientific process and analytical issues.
Drive lifecycle improvements with consideration of their impact on filing, critical attributes, and specifications (comparability).
Provide technical expertise while communicating decisions for process improvements, process understanding, and validation in collaboration with Catalent personnel and partners and justifying the strategies selected for client and regulatory agency review.
Act as the technical lead for validation process risk assessments.
Support deviations, and CAPAs including root-cause analysis and corrective action identification.
Train, coach, and mentor others on early and late phase molecule lifecycle, personnel development, and business challenges (including integration of business and technical support).
Provide technical content for key documents (e.g., PPQ or comparability assessments, Control Strategies, Validation Plans, at-scale study protocols) and author content for regulatory submissions; present technical strategies during major health authority interactions and inspections.
Assure compliance with company directives including safety, staff training, and quality systems; mentor staff in lifecycle management
Support development of business strategies to expand molecule lifecycle and validation offerings
Review late-stage client statements of work (SOW) / requests for proposal (RFP) while advising the Business Development and Commercial Operations teams on appropriate scope
Demonstrate a thorough understanding of processes/systems related to the manufacture of drug substance.
Provide technical support during client visits and regulatory audits
Lead or support continuous improvement initiatives to increase revenue, throughput, or other key performance metrics for the site and network.
Perform other responsibilities to support group, site, and network-based initiatives, as required.
Other duties as assigned