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Lead - Process Development, Drug Substance Lifecycle - Madison Wisconsin
Company: Disability Solutions Location: Madison, Wisconsin
Posted On: 05/17/2024
Position Title:-- Lead - Process Development, Drug Substance LifecycleM-F 1st shiftSummary:Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.----The Lead - Process Development, Drug Substance Lifecycle will manage the lifecycle of a drug substance program (or programs) as it progresses into late stage manufacturing. 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. The Lead - Process Development, Drug Substance Lifecycle will be client-facing and require the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.The Role:-- - 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 preferred.
- Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages is preferred.
- Knowledge and experience working in biologics process development and supporting cGMP manufacturing is preferred
- Exceptional attention to detail and accuracy
- Experience in report and documentation skills
- Knowledge of statistical techniques for data analysis and reporting
- Skilled at risk mitigation for function.
- Direct personnel and / or organizational group management experience, including mentoring and training staff members cross-functionallyThe Candidate
- Ph.D. in STEM, or related field with at 0 to 2 years of biopharmaceutical process development or manufacturing experience
- MS in STEM, or related field with 3 to 5 years of biopharmaceutical process development or manufacturing experience
- B.S/B.A. in STEM, or related field with at least 6 to 9 years of biopharmaceutical process development or manufacturing experience.
- Demonstrated excellence in prior roles can be a substitute for the minimum years of experience.--
- Experience with statistical software (MiniTab, JMP, SAS, Tableau, Spotfire) and Microsoft Office, especially Excel and Word. Ability to learn and use software packages (e.g., TrackWise--, ComplianceWire--, Unicorn--).
- Lab and/or process scale chromatography and filtration (viral, chromatography, tangential flow) experience
- Strong technical knowledge and/or hands-on experience with biological manufacturing and validation concepts and procedures in a GMP environment.
- Capable of rapid learning of unfamiliar principles or techniques with minimum training.
- Ability to plan, schedule, and carry out work for successful project completion, while integrating timelines and meeting milestones.
- Understanding and application of quality risk management and associated tools (Hazard Analysis, FMEA, etc.).
- Strong interpersonal and presentation skills to discuss technical concepts internally and with clients.
- Demonstrated ability to understand and relay/incorporate expertise given from technical staff outside their area of expertise to their program.
- Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions.
- Ability to troubleshoot and collaborate on complex problems to identity solutions.Position Benefits:
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