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Senior Analytical Scientist – API
Novo NordiskSenior Analytical Scientist leading GMP analytical programs for synthetic APIs at Novo Nordisk. Supporting CMO partnerships, regulatory submissions, method transfers, and commercialization.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in GMP compliance, regulatory submissions, and analytical method transfer within the pharmaceutical sector. Proven ability to lead analytical activities and optimize processes while fostering collaboration with stakeholders.
Highest-signal resume keywords
GMP ExpertiseRegulatory SubmissionsAnalytical Method TransferPharmaceutical DevelopmentSOP Authoring
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Analytical ProgramsMethod ValidationDeviation ManagementChange RequestsOut-Of-SpecificationsChemical SynthesisLate-Phase DevelopmentGMP RegulationsICH GuidelinesQC Laboratory Experience
Soft Skills
CollaborationCommunicationLeadership
Certifications & Qualifications
Master’s Degree in PharmacyMaster’s Degree in ChemistryMaster’s Degree in BiochemistryMaster’s Degree in Chemical Engineering
Industry Keywords
Contract Manufacturing OrganisationsPharmaceutical SectorProduct Life CycleTechnical Transfer PlansStakeholder Engagement
About the role
Key responsibilities & impact- Provide scientific and GMP expertise to Contract Manufacturing Organisations (CMOs) and other stakeholders
- Ensure robust and efficient analytical programs are implemented at CMOs and maintained throughout the product life cycle
- Lead analytical activities, including submissions, from post-phase 3 clinical studies through the commercial life cycle
- Lead regulatory submissions
- Transfer and implement analytical methods to and from collaborative partners
- Author and edit SOPs
- Review protocols, reports, technical transfer plans, and other documentation
- Build and optimize internal processes and SOPs
- Set direction and define ways of working in a developing area
- Take products to market by bridging development and commercial aspects
- Foster collaboration with subject matter experts and stakeholders
- Travel and attend meetings outside normal working hours when required
Requirements
What you’ll need- Minimum Master’s degree in Pharmacy, Chemistry, Biochemistry, Chemical Engineering, or a similar scientific discipline
- Minimum 5 years of experience in a similar position within the pharmaceutical sector
- Hands-on experience working in a GMP-regulated environment, such as a QC laboratory
- Strong knowledge of GMP, ICH guidelines, and pharmaceutical regulatory requirements
- Experience with deviations, change requests, out-of-specifications, and method validation
- Full professional proficiency in spoken and written English
- Knowledge of late-phase pharmaceutical development projects is advantageous
- Previous experience with chemical synthesis, such as small molecules or peptides, is advantageous
- Ability to travel as required
- Ability to attend meetings outside normal working hours when required
Benefits
Comp & perks- Continuous learning
- Career development
- Benefits tailored to your life and career stage
- Short-term and/or long-term incentives may be included
- Other employee benefits based on position level, location, functional area and relevant market benchmarks
- Inclusive recruitment process and equality of opportunity