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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in technology transfer and process development within a regulated biopharmaceutical environment, with a strong focus on compliance, risk management, and team leadership. Proven ability to drive continuous improvement and data-driven decision-making while fostering a culture of diversity and inclusion.
Highest-signal resume keywords
Technology Transfer ManagementProcess DevelopmentBiopharmaceutical Industry KnowledgeRegulatory Compliance (EMA, FDA, USDA)Team Leadership and Coaching
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Technology TransferProcess DevelopmentStatistical Process ControlDesign of ExperimentsRisk AssessmentManufacturing Change ControlProcess Performance QualificationBiomanufacturingAseptic ProcessingFilling and Lyophilization
Soft Skills
Project LeadershipDecision MakingEmployee CoachingTalent ManagementDiversity, Equity, & Inclusion Commitment
Industry Keywords
BiopharmaceuticalRegulated EnvironmentTechnical OperationsLife Sciences R&DMatrix OrganizationCommercial BiomanufacturingHoshin PlanningSafety ComplianceEmployee DevelopmentPerformance Feedback
About the role
Key responsibilities & impact- Develop robust processes and execute right-first-time technology transfers from R&D to operations for antigens and final products
- Collaborate with R&D, operations, quality, and regulatory groups to meet file-on-time and launch-on-time targets
- Manage and coach the technology transfer team
- Build and sustain an engaged team and drive safety, compliance, technical excellence, and employee development
- Set aligned objectives, provide performance feedback, conduct development conversations, and support career progression
- Lead talent management, retention, and succession planning
- Drive data-driven decision-making across technology transfers
- Lead continuous process improvements to enhance processes and reduce cost of goods
- Oversee risk identification and mitigation methodologies, including FMEA
- Manage technical stage-gate reviews and drive lab experiments when needed
- Manage strategic initiatives and oversee execution by the technology transfer team
- Contribute to the Regional Technology Hoshin by aligning internal goals with the technology organization
- Collaborate across R&D, operations, site support, supply chain, and regulatory functions in the US region
Requirements
What you’ll need- Bachelor of Science in Chemical Engineering, Biotechnology, Biochemistry, Protein Chemistry, Biology or related field
- Bachelor’s degree with at least 8 years of relevant post-graduate experience OR Master of Science degree with at least 6 years of relevant post-graduate experience OR doctoral degree with at least 4 years of relevant post-graduate experience
- Minimum of 3 years of direct management experience
- Minimum of 4 years of relevant experience in technology transfer, process development, technical operations, or manufacturing operations within a regulated biopharmaceutical environment
- Effective project leadership in a complex, fast-paced matrix organization
- Strong working knowledge of EMA, FDA, and/or USDA regulations and guidelines
- Demonstrated commitment to Diversity, Equity, & Inclusion
- Demonstrated successes with talent management, process development/technology transfer and strategic initiatives
- Demonstrated experience with USDA regulations
- Demonstrated experience in commercial biomanufacturing, including sterile/aseptic, bulk drug substance, filling, or lyophilization
- Strong working knowledge of biopharmaceutical business processes, including process performance qualification/validation, risk assessments, CMC regulatory processes, and manufacturing change control
- Demonstrated experience with statistical process control and/or design of experiments
- Required skills include biopharmaceutical industry, coaching employees, decision making, life sciences industry, life sciences R&D, people leadership, process development, technical operations, and technology transfer
- No visa sponsorship
- Valid driving license required
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Relocation: Domestic