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Senior Analytical Scientist – Synthetic API
Novo Nordisk. Act as the scientific lead for analytical activities, providing expertise to CMOs and internal stakeholders .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmaceutical analytical science, including strong knowledge of GMP and ICH guidelines, with a proven ability to lead analytical activities and regulatory submissions. Possesses excellent communication skills to convey complex topics and a collaborative approach to problem-solving and relationship-building.
Highest-signal resume keywords
Pharmaceutical Analytical ScienceGMP KnowledgeRegulatory SubmissionsAnalytical Method ValidationCollaborative Problem-Solving
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Analytical Method DevelopmentSOP AuthoringChange ControlOut-Of-Specification InvestigationsAnalytical Documentation ReviewQuality ControlRegulatory ComplianceProcess ImprovementAnalytical Method TransferScientific Judgement
Soft Skills
Effective CommunicationCollaborative Working StyleOwnership of ResponsibilitiesFocus on QualityRelationship Building
Industry Keywords
GMP-Regulated EnvironmentICH GuidelinesPharmaceutical Regulatory RequirementsQC LaboratoryInternational Travel
About the role
Key responsibilities & impact- Act as the scientific lead for analytical activities, providing expertise to CMOs and internal stakeholders
- Lead analytical activities and contributions to regulatory submissions from late-stage development through the commercial lifecycle
- Lead the transfer and implementation of analytical methods between Novo and external partners
- Author and review analytical documentation, including SOPs, protocols, reports and method transfer plans
- Develop and improve internal processes and SOPs to support consistent and efficient ways of working
- Ensure robust and efficient analytical methods and programmes are established at manufacturing partners and maintained throughout the product lifecycle
- Work alongside analytical specialists and project managers through open discussion, knowledge sharing and collaborative problem-solving
- Attend occasional meetings across time zones and undertake international travel
Requirements
What you’ll need- A master’s degree or higher in Pharmacy, Chemistry, Biochemistry, Chemical Engineering or a related scientific discipline
- At least five years of relevant experience in pharmaceutical analytical science
- Practical experience working in a GMP-regulated environment, such as a QC laboratory
- Strong knowledge of GMP, relevant ICH guidelines and pharmaceutical regulatory requirements
- Experience with deviations, change control, out-of-specification investigations and analytical method validation
- Full professional proficiency in written and spoken English
- Sound scientific judgement and ability to communicate complex analytical topics clearly to different stakeholders
- Collaborative working style, ownership of responsibilities and strong focus on quality
- Comfortable setting direction when processes are still developing and building effective relationships with colleagues and external partners
Benefits
Comp & perks- Short-term and/or long-term incentives
- Other employee benefits based on position level, location, functional area and relevant market benchmarks
- International travel opportunities (<14 days a year)