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Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in technology transfer and process validation within the biopharmaceutical industry, with a strong focus on upstream and downstream manufacturing processes. Proficient in regulatory compliance, risk assessment, and effective communication of complex process data.
Highest-signal resume keywords
Technology Transfer ExperienceProcess Validation ExpertiseGMP KnowledgeDeltaV Process ControlRisk Assessment Tools Familiarity
About the role
Key responsibilities & impact- Support technology transfer of late-stage molecules, commercial manufacturing, and/or PPQ campaigns
- Support site-to-site tech transfer activities
- Perform gap analyses and risk assessments, develop mitigation plans, and build design spaces (PAR and NOR ranges) for critical process parameters
- Support development, review, and approval of technical documentation, including global protocols, batch records, and reports for engineering, GMP, and PPQ runs
- Author templates for process validations and continued process verification strategies
- Analyze process data, including annual periodic reviews across manufacturing sites
- Author process transfer documents and/or process control strategies for Phase III and commercial programs
- Support tech transfer leads with network alignment strategy and global templates/documentation for tech transfer and new product introduction
- Provide person-in-plant support
- Assist with regulatory submissions
- Support regulatory and site inspections
- Serve as a technical resource for upstream or downstream manufacturing processes and platforms
- May lead projects within functional area expertise
Requirements
What you’ll need- Bachelor’s degree in engineering, sciences, or related program with 5+ years of relevant experience, or 2 years of experience with an MS degree
- Experience supporting process transfer / technology transfer projects and teams in the biopharmaceutical industry
- Familiarity with process risk assessment tools (e.g., FMEA), process models, and process trending
- Solid understanding of upstream processing, including single-use bioreactor operations and perfusion technology
- Solid understanding of downstream processing, including process chromatography, continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration
- Solid understanding of GMP concepts and quality systems
- Hands-on experience with disposable-based manufacturing technologies from bench-scale through commercial scale
- Working knowledge of manufacturing process equipment and automation systems
- Strong focus on quality, attention to detail, and effective task/time management and organizational skills
- Ability to organize, analyze/interpret, and effectively communicate process data
- Good interpersonal, team, and collaborative skills
- Excellent oral and written communication skills
- Practical experience or knowledge of upstream or downstream and disposable manufacturing technologies
- Ability to solve complex technical problems
- Ability to work independently and in project teams
- Ability to navigate global regulatory CMC documents
- Experience supporting late-stage manufacturing, tech transfer, and/or process validation studies
- Experience with DeltaV for process control
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 including professional courses, mentorship, and new projects
- Flexible work options
- Inclusive culture
- Innovative projects and cutting-edge technology
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process TransferUpstream ProcessingDownstream ProcessingProcess Risk AssessmentProcess Data AnalysisTechnical Documentation AuthoringQuality Systems UnderstandingDisposable Manufacturing TechnologiesProcess Control StrategiesRegulatory Submissions Support
Soft Skills
Attention to DetailEffective CommunicationOrganizational SkillsTeam CollaborationProblem-Solving Ability
Tools & Technologies
FMEASingle-Use Bioreactor OperationsPerfusion TechnologyProcess ChromatographyContinuous ChromatographyViral FiltrationTangential Flow FiltrationManufacturing Process EquipmentAutomation SystemsGlobal Regulatory CMC Documents
Industry Keywords
Biopharmaceutical IndustryGMPProcess ValidationTech TransferCommercial Manufacturing