FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in downstream processing and technology transfer for clinical and commercial biologics manufacturing, with a strong focus on regulatory compliance and process validation strategies. Proven ability to lead projects, mentor teams, and develop technical documentation to support manufacturing operations.
Highest-signal resume keywords
Downstream Processing ExpertiseTechnology Transfer LeadershipRegulatory CMC Document AuthoringProcess Validation ExperienceGMP Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Downstream Process ChromatographyContinuous ChromatographyViral FiltrationTangential Flow FiltrationSingle-Use Bioreactor OperationsProcess Risk Assessment ToolsStatistical AnalysisProcess Control StrategiesProcess ValidationManufacturing Process Lifecycle Management
Soft Skills
Task ManagementOrganizational SkillsMentoringProblem SolvingAttention to Detail
Tools & Technologies
DeltaV Automation SystemsManufacturing Execution SystemsContinuous Process Monitoring Strategies
Industry Keywords
Biologics ManufacturingClinical ManufacturingCommercial QualificationGMP ConceptsRegulatory Submissions
About the role
Key responsibilities & impact- Provide project leadership for late-stage molecule process transfer/technology transfer for clinical and commercial biologics manufacturing
- Support development and maintenance of technical documentation for process control and validation strategies
- Support implementation of network alignment strategy and creation of global templates/documentation for technology transfer and new product introduction across the manufacturing network
- Provide onsite support for new facility or client startup engineering runs and performance qualification runs
- Assist in generation of relevant regulatory submissions
- Provide support for regulatory and site inspections
- Manage and mentor junior process engineers or direct reports
- Lead site-to-site technology transfer activities
- Lead gap analyses and risk assessments, ensure mitigation plans are in place, and establish design spaces for critical process parameters
- Support development, review, and approval of technical documentation, including global performance qualification protocols, batch records, and engineering, GMP, and PPQ run reports
- Lead development and implementation of templates for process validations and continued process verification strategies
- Lead analysis of process data, including annual periodic reviews across manufacturing sites
- Develop process transfer documents and process control strategies for Phase III and commercial programs at receiving sites
Requirements
What you’ll need- Bachelor’s degree in engineering science or related program with 12+ years relevant experience, or 8+ years of relevant experience with an MS
- Subject matter expertise in downstream processing, including downstream process chromatography, continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration
- Knowledge of single-use bioreactors and perfusion technology
- Subject matter expertise in cell culture biopharmaceutical manufacturing or development of cell culture processes, including perfusion technologies, single-use bioreactor operations, and scale-up strategies
- Experience leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial qualification PPQ campaigns or commercial campaign support
- Understanding of GMP concepts and quality systems
- Experience developing and providing oversight to continuous process monitoring strategies and process validation status throughout the commercial lifecycle
- Knowledge of manufacturing process lifecycle management principles
- 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, such as FMEA, and facilitating risk assessments
- Working knowledge of manufacturing process equipment, DeltaV automation systems, and Manufacturing Execution Systems
- Strong focus on quality and attention to detail
- Effective task/time management and organizational skills
- Ability to organize, analyze/interpret, and translate downstream expertise into global procedures/templates
- Demonstrated skill managing and mentoring direct reports
- Recognized technical mastery of upstream or downstream operations and continuous processing from bench-scale through commercial manufacturing scale
- Knowledge and expertise to solve complex technical problems and apply novel approaches
- Experience leading technical projects with external collaborators and vendors
- Ability to navigate global regulatory CMC documents
- High initiative, flexibility, follow-through, and accountability
Benefits
Comp & perks- Discretionary annual bonus
- Medical, Dental and Vision benefits
- Short-term and long-term disability
- Company paid basic life insurance
- 401k company match
- Generous paid time off
- Paid holiday
- Wellness benefits
- Transportation benefits
- Growth opportunities through professional courses, mentorship, and new projects
- Flexible work options
- Inclusive work environment