AstraZeneca

1 day ago

Senior Specialist, Technical Services

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 8 hours agoStatus: Live

Job Summary

Support cGMP manufacture of biological bulk drug substance at the Alexion facility in Blanchardstown, providing upstream processing expertise for technology transfer, validation, and routine commercial manufacturing. Lead technical transfer and validation milestones, including PPQ, process monitoring, risk assessment, and process improvement. Author/review technical documentation, coordinate laboratory studies with Global Process Development, and provide on-floor troubleshooting during commercial-scale operations and audits.

Location: Ireland

Workplace: Onsite

Employment Type: Full time

Job Function: Solutions Engineering & Sales Engineering

Seniority: Mid level

Key Responsibilities

•Provide upstream process expertise (cell culture focus) including media preparation, scale-up, bioreactors, and harvest centrifugation/clarification.
•Support technology transfer and validation for new/existing drug substance processes to ensure facility startup and process qualification.
•Author and review process transfer documentation, gap assessments, technical protocols/reports, and process validation strategy documents.
•Lead and execute plant-supporting and technical studies on the manufacturing floor at commercial scale, coordinating laboratory study requirements with Global Process Development.
•Provide on-floor support for troubleshooting, lead manufacturing investigations into process deviations, and support regulatory submissions/inspections as an SME.

Key Requirements

•Minimum 5 years’ experience in a pharmaceutical manufacturing organization with expertise in Bulk Drug Substance manufacturing, including cell culture unit operations and New Product Introduction technology transfer.
•B.Sc. in Biochemistry, Biology, Chemistry (or equivalent) OR B.Eng. Process or Chemical Engineering.
•M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry (or equivalent) OR B.Eng. Process or Chemical Engineering.
•Comprehensive understanding of cGMP requirements for clinical/commercial biopharmaceutical manufacturing and ability to implement best practices for multi-product bulk manufacturing operations.
•Ability to develop, build, present, and defend technical/scientific approaches in written and verbal form, partnering with stakeholders without solid line authority.

Experience:5+ yearsPharmaceutical manufacturingBiopharmaceuticalsBiologicsBiological drug substanceCell culture

Education:Bachelor's in Biochemistry, Biology, Chemistry (or equivalent) OR Process/Chemical Engineering

Skills:Interpersonal skillsTechnical writingOrganizational skillsStrategic thinkingStakeholder influence

Tech Stack:CGMPQRMPPQProcess monitoringRisk assessmentPATChange control systemCTDEHS policyTechnology transferValidation documentationBills of Materials

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

1 day ago

Senior Specialist, Technical Services

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 8 hours agoStatus: Live

Job Summary

Location: Ireland

Workplace: Onsite

Employment Type: Full time

Job Function: Solutions Engineering & Sales Engineering

Seniority: Mid level

Key Responsibilities

•Provide upstream process expertise (cell culture focus) including media preparation, scale-up, bioreactors, and harvest centrifugation/clarification.
•Support technology transfer and validation for new/existing drug substance processes to ensure facility startup and process qualification.
•Author and review process transfer documentation, gap assessments, technical protocols/reports, and process validation strategy documents.
•Lead and execute plant-supporting and technical studies on the manufacturing floor at commercial scale, coordinating laboratory study requirements with Global Process Development.
•Provide on-floor support for troubleshooting, lead manufacturing investigations into process deviations, and support regulatory submissions/inspections as an SME.

Key Requirements

•Minimum 5 years’ experience in a pharmaceutical manufacturing organization with expertise in Bulk Drug Substance manufacturing, including cell culture unit operations and New Product Introduction technology transfer.
•B.Sc. in Biochemistry, Biology, Chemistry (or equivalent) OR B.Eng. Process or Chemical Engineering.
•M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry (or equivalent) OR B.Eng. Process or Chemical Engineering.
•Comprehensive understanding of cGMP requirements for clinical/commercial biopharmaceutical manufacturing and ability to implement best practices for multi-product bulk manufacturing operations.
•Ability to develop, build, present, and defend technical/scientific approaches in written and verbal form, partnering with stakeholders without solid line authority.

Experience:5+ yearsPharmaceutical manufacturingBiopharmaceuticalsBiologicsBiological drug substanceCell culture

Education:Bachelor's in Biochemistry, Biology, Chemistry (or equivalent) OR Process/Chemical Engineering

Skills:Interpersonal skillsTechnical writingOrganizational skillsStrategic thinkingStakeholder influence

Tech Stack:CGMPQRMPPQProcess monitoringRisk assessmentPATChange control systemCTDEHS policyTechnology transferValidation documentationBills of Materials

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