Key skills
CommunicationTime Management
About this role
Role Overview
- Support downstream technology transfer of a Late-Stage molecule/ commercial manufacturing and/or PPQ campaign support
- Support site to site Tech Transfer activities
- Support technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place
- 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
- Author templates for Process Validations and Continued Process Verification strategies
- Conduct the analysis of process data including annual periodic reviews across the network of Manufacturing sites
- Author Process transfer document and or Process Control strategy for phase III and commercial programs for receiving sites across the Just MFG network
Requirements
- Bachelor’s degree in engineering, sciences, or related program with 5 + years of relevant experience
- 2 years of experience with an MS degree
- Experience supporting process transfer / technology transfer projects and teams in the biopharmaceutical industry; commercial manufacturing campaign support is a plus
- Familiar with process risk assessment tools (e.g., FMEA)
- Solid understanding of downstream processing including process chromatography and specifically continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration
- Solid understanding of GMP concepts and quality systems
- Hands on experience of downstream disposable-based manufacturing technologies from bench-scale through commercial scale
- Working knowledge of manufacturing process equipment and automation systems
- Strong focus on quality and attention to detail
- Effective task/ time management organizational skills
- Ability to organize, analyze/interpret, and effectively communicate process data
- Good interpersonal, team, and collaborative skills
- Excellent oral and written communication skills
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
- paid holiday
- wellness and transportation benefits