AstraZeneca

1 day ago

Technical Services Specialist, Downstream

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 7 hours agoStatus: Live

Job Summary

Own downstream process technical performance at the Dublin (Blanchardstown) site, translating complex requirements into right-first-time biological bulk drug substance manufacturing. Lead technology transfer and validation activities, support CPV strategy and control strategies, and troubleshoot deviations on the floor. Manage materials integration, documentation for validation/CTD contributions, and change control while upholding cGMP and EHS standards through audits and inspections.

Location: Ireland

Workplace: Onsite

Employment Type: Full time

Job Function: Administration & Executive Assistance

Seniority: Mid level

Key Responsibilities

•Provide downstream process ownership across buffer preparation, chromatography, ultrafiltration/diafiltration, viral reduction/inactivation, drug substance formulation and bulk fill.
•Lead and support technology transfer, process performance qualification (PPQ), and facility/process start-up activities using risk assessments.
•Lead or support the site CPV program by defining control strategies and translating data into actions that sustain process capability and product quality.
•Manage materials integration by generating materials lists/specifications/testing requirements and controlling changes to protect continuity of supply.
•Provide real-time troubleshooting during manufacturing, investigate process deviations to root cause, and drive durable corrective actions while authoring/maintaining validation and regulatory documentation.

Key Requirements

•B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
•Minimum 3+ years’ experience in Technical Services / Process Development / Manufacturing Support for biological bulk drug substance manufacturing.
•Technical and operational knowledge of multiple unit operations in cell culture processing.
•Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
•Ability to present and defend technical/scientific approaches and complete technical writing tasks.

Experience:3+ yearsBiopharmaceutical manufacturingBiological drug substanceCell culture processing

Education:Bachelor's

Skills:Interpersonal skillsWork effectively in a matrix organizationTechnical communicationIndependent driveDetail orientationTechnical writing competency

Tech Stack:CGMPTechnology transferProcess validationPPQQRMContinuous Process Verification (CPV)Control strategyChromatographyUltrafiltrationDiafiltrationViral reduction and inactivationDrug substance formulationBulk fillChange controlCommon Technical Document (CTD)CMCEHSAuditsHealth authority inspectionsMaterials lists

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

Technical Services Specialist, Downstream

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 7 hours agoStatus: Live

Job Summary

Location: Ireland

Workplace: Onsite

Employment Type: Full time

Job Function: Administration & Executive Assistance

Seniority: Mid level

Key Responsibilities

•Provide downstream process ownership across buffer preparation, chromatography, ultrafiltration/diafiltration, viral reduction/inactivation, drug substance formulation and bulk fill.
•Lead and support technology transfer, process performance qualification (PPQ), and facility/process start-up activities using risk assessments.
•Lead or support the site CPV program by defining control strategies and translating data into actions that sustain process capability and product quality.
•Manage materials integration by generating materials lists/specifications/testing requirements and controlling changes to protect continuity of supply.
•Provide real-time troubleshooting during manufacturing, investigate process deviations to root cause, and drive durable corrective actions while authoring/maintaining validation and regulatory documentation.

Key Requirements

•B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
•Minimum 3+ years’ experience in Technical Services / Process Development / Manufacturing Support for biological bulk drug substance manufacturing.
•Technical and operational knowledge of multiple unit operations in cell culture processing.
•Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
•Ability to present and defend technical/scientific approaches and complete technical writing tasks.

Experience:3+ yearsBiopharmaceutical manufacturingBiological drug substanceCell culture processing

Education:Bachelor's

Skills:Interpersonal skillsWork effectively in a matrix organizationTechnical communicationIndependent driveDetail orientationTechnical writing competency

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