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Associate Scientist, Quality Control
Johnson & Johnson. Support microbiological testing aspects associated with Drug Substance and Drug Product manufacturing .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in microbiological testing and method development within the pharmaceutical industry, with a strong focus on regulatory compliance and project management. Capable of training technicians and improving testing methodologies to enhance operational excellence.
Highest-signal resume keywords
PhD In Biochemistry Or MicrobiologyMinimum 6 Years Experience In Pharmaceutical QCExpertise In Method Development And ValidationUnderstanding Of FDA And EU GMPLEAN And Greenbelt Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Microbiological TestingMethod DevelopmentMethod ValidationAnalytical Method TransfersStatistical Analyses Using R StudioStatistical Analyses Using MinitabStatistical Analyses Using MatlabTroubleshooting SkillsInvestigational TestingProject Management
Soft Skills
Ability To Work IndependentlyAbility To Manage Stakeholder RelationshipsAbility To Critically Assess ReportsAbility To Train TechniciansDemonstrated Project Management Skills
Tools & Technologies
R StudioMinitabMatlab
Certifications & Qualifications
LEAN CertificationGreenbelt Certification
Industry Keywords
MicrobiologyPharmaceutical IndustryQC LaboratoryGMP RequirementsAnalytical Technical TransferCell CulturesCompendial MethodsDrug SubstanceDrug ProductAI Concepts And Frameworks
About the role
Key responsibilities & impact- Support microbiological testing aspects associated with Drug Substance and Drug Product manufacturing
- Act as the scientific responsible person within the Microbiology testing team
- Troubleshoot microbiological methods
- Proactively improve test methods to stimulate executional excellence
- Prepare protocols and reports for continuous improvement projects
- Plan resources and equipment for ongoing project activities
- Perform investigational testing
- Train technicians for new methods
- Oversee and coordinate multiple projects
- Report to the (Sr) Manager of the QC Microbiological testing team
Requirements
What you’ll need- PhD or equivalent in Biochemistry, Microbiology or a related field required
- Minimum of 6 years of experience in the pharmaceutical industry, specifically within QC, with strong emphasis on microbiology
- Expertise in method development/improvement, method validation and analytical method transfers
- Comprehensive understanding of worldwide regulatory GMP requirements
- Knowledge of FDA and EU GMP
- Ability to work independently and in team environments
- Ability to manage stakeholder relationships and address biological testing issues
- Ability to critically assess analytical investigation reports
- Ability to conduct statistical analyses using R studio, Minitab and Matlab
- Extensive operational experience in a Pharmaceutical QC laboratory with Drug Substance and Drug Product processes
- Qualified or able to be trained and qualified for relevant assays
- Ability to perform investigational testing and train technicians for new methods
- Strong understanding of analytical technical transfer processes and compliance requirements
- Troubleshooting skills
- Advanced knowledge of modern methodologies
- Familiarity with cell cultures, microbiology methods or compendial methods is advantageous
- Demonstrated project management skills
- LEAN and Greenbelt certification
- Understanding of AI concepts and frameworks, including responsible and ethical AI practices
- Experience generating effective prompts to improve efficiency and productivity
Benefits
Comp & perks- Annual bonus with set target (% of pay), depending on pay grade/location and performance
- Vacation days
- Parental leave for a minimum of 12 weeks
- Bereavement leave
- Caregiver leave
- Volunteer leave
- Well-being reimbursement
- Programs for financial, physical and mental health
- Service anniversary awards
- Recognition awards
- Insurance plans for employees and eligible dependents in some locations