Lead - Process Development, Drug Substance Lifecycle
Catalent
- Madison, WI
- Permanent
- Full-time
- 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-functionally
- 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.
- 152 hours PTO & 8 Holidays
- Medical, Dental & Vision Benefits and 401k
- Tuition Reimbursement