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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Pathogen Safety, including risk assessments, contamination control strategies, and regulatory compliance. Proven ability to influence cross-functional teams and provide scientific guidance in a biopharmaceutical environment.
Highest-signal resume keywords
Pathogen Safety ExpertiseRisk AssessmentCross-Functional CollaborationStakeholder ManagementScientific Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
VirologyMicrobiologyImmunologyBiologics Manufacturing SupportPharmacovigilanceContamination ControlRegulatory ComplianceComplex Problem SolvingScientific AssessmentPathogen Safety Training
Soft Skills
Influencing Without AuthorityCommunication SkillsStakeholder EngagementTime ManagementCoaching
Certifications & Qualifications
Postgraduate DegreePhD Preferred
Industry Keywords
Biopharmaceutical IndustryProduct LifecycleGlobal CollaborationQuality StandardsMatrix Organization
About the role
Key responsibilities & impact- Serve as the senior pathogen safety scientific expert and primary interface for the assigned site
- Independently assess and resolve complex pathogen safety matters throughout the product lifecycle
- Provide expertise for risk assessments, deviations, changes, product complaints, pharmacovigilance investigations, contamination control strategies, audits, inspections, and regulatory requests
- Partner with Operations, Quality, Regulatory, MS&T, and other functions to provide scientific recommendations and drive resolution
- Evaluate emerging pathogens and assess potential impact to products and operations
- Influence decisions and drive alignment across functions and sites without direct authority
- Contribute to global Pathogen Safety initiatives, standards, best practices, and knowledge sharing
- Provide scientific coaching, technical guidance, and pathogen safety training
- Support continuous improvement of pathogen safety processes, risk assessments, and tools
- Ensure activities meet applicable regulatory requirements and internal quality standards
- Serve as the senior scientific interface for pathogen safety at the Holly Springs, NC or Melbourne, Australia site and across broader Operations
Requirements
What you’ll need- Postgraduate degree, preferably PhD, in Virology, Biology, Microbiology, Immunology, or a related life sciences discipline
- 5+ years of relevant biopharmaceutical industry experience
- Significant experience in pathogen safety, viral safety, biologics manufacturing support, or a related discipline
- Strong expertise in pathogen safety, including virus and prion safety
- Demonstrated ability to independently lead complex scientific assessments and solve problems
- Experience working cross-functionally in a matrix organization and influencing without direct authority
- Strong stakeholder management and communication skills
- Ability to communicate complex scientific concepts and recommendations to technical and senior business audiences
- Ability to manage multiple priorities in a fast-paced, matrixed environment
- May occasionally require meetings outside standard business hours due to global collaboration
- Some travel to manufacturing/development sites, partners, meetings, or conferences may be required
Benefits
Comp & perks- Opportunity to take on a highly visible senior scientific position while remaining on a scientific career path
- Significant autonomy and broad exposure across Operations, Quality, Regulatory and MS&T
- Opportunity to work on a wide variety of scientific and manufacturing challenges
- Participation in a global Pathogen Safety network
- Opportunity to exchange expertise across international sites
- Opportunity to contribute to global practices
- Opportunity to represent the organization at relevant scientific and industry forums
- Inclusion and Belonging culture
- Reasonable accommodation available for individuals with disabilities