Key skills
Statistical AnalysisMentoringTime Management
About this role
Role Overview
- Project Lead for technology transfer of a Late-Stage molecule/ commercial manufacturing and/or PPQ campaign support.
- Lead site to site Tech Transfer activities
- Lead technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations.
- Support development, review and approval of technical documentation including global protocols for performance qualifications, batch records, and reports related to engineering, GMP and PPQ runs.
- Lead the development and implementation templates for Process Validations and Continued Process Verification strategies.
- Lead the analysis of process data including annual periodic reviews across the network of Manufacturing sites.
- Develop Process transfer document and or Process Control strategy for phase III and commercial programs for receiving sites across the MFG network.
Requirements
- Bachelor’s degree in engineering science or related program with 12+ years relevant experience or 8+ years of relevant experience with an MS.
- Considered a subject matter expert in downstream processing, including downstream process chromatography and specifically continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration, but also knowledgeable in single-use bioreactors and perfusion technology.
- Considered a subject matter expert in cell culture biopharmaceutical manufacturing and or development of cell culture processes including perfusion technologies, single use bioreactor operations, and scale-up strategies.
- Experienced in leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial qualification PPQ campaigns/ commercial campaign support.
- Understanding of GMP concepts and quality systems necessary to execute process transfer and process validation activities.
- Experience developing and providing oversight to continuous process monitoring strategies and process validation status throughout commercial lifecycle.
- Apply manufacturing process lifecycle management principles for establishment and continuous improvement of process control strategy.
- Experience authoring regulatory CMC documents, coordinating responses to health authority questions, and providing inspection support.
- Solid background in statistical analysis
- Significant experience with process risk assessment tools (e.g. FMEA), and facilitating risk assessments.
- Working knowledge of manufacturing process equipment, DeltaV automation systems, and Manufacturing Execution Systems.
- Candidate must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills.
- Strategic mindset, ability to organize, analyze/interpret, and effectively translate downstream expertise into global procedures/templates.
- Demonstrated skill managing and mentoring direct reports.
Benefits
- discretionary annual bonus
- comprehensive benefits to include Medical, Dental and Vision
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- generous paid time off and paid holiday
- wellness and transportation benefits