Senior Analytical Scientist – API

Jobtailor; Høje-Taastrup Kommune; On-site; DKK 700,000 - 900,000; Full time

Job summary

Jobtailor seeks a scientifically strong professional to provide GMP expertise to CMOs and stakeholders, lead analytical activities from late-phase development to the commercial life cycle, and drive regulatory submissions. The role also involves transferring methods and authoring SOPs while reviewing critical documents and optimizing processes.

You will collaborate with SMEs and cross-functional teams, ensuring compliant analytical programs and robust transfer plans, with travel as needed to

Qualifications

• Master’s degree in a scientific discipline (Pharmacy, Chemistry, Biochemistry, Chemical Engineering or similar).
• Minimum 5 years in a similar pharmaceutical role.
• GMP-regulated environment experience (QC laboratory preferred).
• Knowledge of GMP, ICH guidelines and regulatory requirements.
• Experience with deviations, change requests, OOS, and method validation.
• Proficiency in English (spoken and written).

Responsibilities

• Provide scientific and GMP expertise to CMOs and stakeholders.
• Ensure robust analytical programs at CMOs and throughout product life cycle.
• Lead analytical activities and submissions from post-phase 3 through commercial life cycle.
• Lead regulatory submissions.
• Transfer and implement analytical methods with collaborators.
• Author and edit SOPs; review protocols and reports.
• Build and optimize internal processes and SOPs.
• Set direction in a developing area and bridge development with commercial aspects.
• Foster collaboration with SMEs and stakeholders.
• Travel and attend meetings outside normal hours when required.

Skills

GMP Expertise

Regulatory Submissions

Analytical Method Transfer

Pharmaceutical Development

SOP Authoring

Education

Master’s Degree in Pharmacy

Master’s Degree in Chemistry

Master’s Degree in Biochemistry

Master’s Degree in Chemical Engineering

Job description

• 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

• 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

Core Competencies

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 Expertise
• Regulatory Submissions
• Analytical Method Transfer
• Pharmaceutical Development
• SOP Authoring

ATS Optimization Keywords

Hard Skills

• Analytical Programs
• Method Validation
• Deviation Management
• Change Requests
• Out-Of-Specifications
• Chemical Synthesis
• Late-Phase Development
• GMP Regulations
• ICH Guidelines
• QC Laboratory Experience

Soft Skills

• Collaboration
• Communication
• Leadership

Certifications & Qualifications

• Master’s Degree in Pharmacy
• Master’s Degree in Chemistry
• Master’s Degree in Biochemistry
• Master’s Degree in Chemical Engineering

Industry Keywords

• Contract Manufacturing Organisations
• Pharmaceutical Sector
• Product Life Cycle
• Technical Transfer Plans
• Stakeholder Engagement