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 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
- 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) developing process models, and process trending
- Solid understanding of downstream processing including process chromatography and specifically continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration either at Manufacturing scale or in process development of biologics
- Solid understanding of GMP concepts and quality systems necessary to support Tech Transfer and process validation activities
- Hands on experience of downstream disposable-based manufacturing technologies from bench-scale through commercial scale
- Working knowledge of manufacturing process equipment and automation systems
- Candidate must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills
- Ability to organize, analyze/interpret, and effectively communicate process data
- Good interpersonal, team, and collaborative skills are a must
- 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