AstraZeneca

2 days ago

Senior Specialist, Commercial Stability

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 19 hours agoStatus: Live

Job Summary

Own commercial stability decisions that protect registered shelf-life and help ensure medicines remain available for patients. Lead the Commercial Stability Programme in Dublin, selecting commitment batches, defining PPQ/technical transfer/for-cause study designs, and overseeing stability study governance across products. Write and review protocols and reports, interpret stability data to assess risk, drive investigations and effective CAPAs, and serve as the stability SME during Health Authority inspections.

Location: Dublin

Workplace: Onsite

Employment Type: Full time

Job Function: Solutions Engineering & Sales Engineering

Seniority: Mid level

Key Responsibilities

•Select annual stability commitment batches and manage sample requests with manufacturing sites.
•Define PPQ, technical transfer, and for-cause stability study designs in collaboration with technical and project teams.
•Enrol and oversee stability studies across internally and externally managed products, ensuring governance and control throughout the lifecycle.
•Prepare, write, review, and approve stability protocols, investigation reports, statistical assessments, and related documentation.
•Interpret stability data trends to assess risk to registered shelf-life, lead stability investigations and CAPA, and represent the programme as the stability SME during Health Authority inspections.

Key Requirements

•Degree in chemistry or biological science (preferred Analytical Chemistry or Biochemistry) with at least 5 years’ experience in the Pharmaceutical/Biotechnology industry.
•Hands-on experience managing stability programmes in a GMP environment, with advanced knowledge of stability guidelines.
•Ability to work in compliance with cGMPs, ICH guidelines, and safety/regulatory requirements.
•Subject matter expertise in stability processes and programme management.
•Proficiency with MS Office (including MS Excel and MS Project or comparable tools), plus experience using AI tools for data review and technical writing within compliance boundaries.

Experience:5+ yearsPharmaceuticalBiotechnologyGMPQuality systemsRegulated industry

Education:Bachelor's in chemistry or biological science (Analytical Chemistry or Biochemistry preferred)

Skills:CommunicationInterpersonal skillsOrganizational skillsIndependenceTeam collaborationPrioritizationContinuous improvement

Tech Stack:Stability protocolsCGMPsICH guidelinesPPQMS OfficeMS ExcelMS ProjectElectronic Document Management SystemsQuality Management SystemsAI toolsStatistical analysis

Company Brief

AstraZeneca

Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.

Industry: Pharmaceuticals

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Cambridge, United Kingdom

Founded: 1999

Glassdoor: 3.8

Website LinkedIn

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AstraZeneca

2 days ago

Senior Specialist, Commercial Stability

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 19 hours agoStatus: Live

Job Summary

Location: Dublin

Workplace: Onsite

Employment Type: Full time

Job Function: Solutions Engineering & Sales Engineering

Seniority: Mid level

Key Responsibilities

•Select annual stability commitment batches and manage sample requests with manufacturing sites.
•Define PPQ, technical transfer, and for-cause stability study designs in collaboration with technical and project teams.
•Enrol and oversee stability studies across internally and externally managed products, ensuring governance and control throughout the lifecycle.
•Prepare, write, review, and approve stability protocols, investigation reports, statistical assessments, and related documentation.
•Interpret stability data trends to assess risk to registered shelf-life, lead stability investigations and CAPA, and represent the programme as the stability SME during Health Authority inspections.

Key Requirements

•Degree in chemistry or biological science (preferred Analytical Chemistry or Biochemistry) with at least 5 years’ experience in the Pharmaceutical/Biotechnology industry.
•Hands-on experience managing stability programmes in a GMP environment, with advanced knowledge of stability guidelines.
•Ability to work in compliance with cGMPs, ICH guidelines, and safety/regulatory requirements.
•Subject matter expertise in stability processes and programme management.
•Proficiency with MS Office (including MS Excel and MS Project or comparable tools), plus experience using AI tools for data review and technical writing within compliance boundaries.

Experience:5+ yearsPharmaceuticalBiotechnologyGMPQuality systemsRegulated industry

Education:Bachelor's in chemistry or biological science (Analytical Chemistry or Biochemistry preferred)

Skills:CommunicationInterpersonal skillsOrganizational skillsIndependenceTeam collaborationPrioritizationContinuous improvement

Tech Stack:Stability protocolsCGMPsICH guidelinesPPQMS OfficeMS ExcelMS ProjectElectronic Document Management SystemsQuality Management SystemsAI toolsStatistical analysis

Company Brief

AstraZeneca

Industry: Pharmaceuticals

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Cambridge, United Kingdom

Founded: 1999

Glassdoor: 3.8

Website LinkedIn