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Company

Original Job Post

AstraZeneca · 2 days ago

Director, Upstream Tech Transfer, Cell Culture and Fermentation Sciences

Gaithersburg, MD

Full-time

Onsite

Director

8+ years exp

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BiopharmaBiotechnology

Comp. & Benefits

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Responsibilities

Lead and/or support upstream process tech transfer, facility fit, and manufacturing readiness to AZ internal facilities and external CMOs/CDMOs.

Provide technical leadership and mentorship on strategies and approaches for early-stage through late-stage tech transfers, process validation, and operation risk assessment.

Author and review technical documentation such as process descriptions, tech transfer protocols, and control strategy documents.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Tech TransferBiologics ProgramsCell CultureGMP ManufacturingPharmaceutical IndustryCMC AspectsBiopharmaceutical DevelopmentMatrix TeamsBusiness Process ImprovementProblem-SolvingCritical ThinkingInterpersonal SkillsCommunication SkillsOrganizationTechnology InnovationBiologics DevelopmentRegulatory GuidelinesUpstream Cell CultureRaw Material RequirementsCell BankingLeadershipTeam Building

Required

BS/MS/PhD in Chemical Engineering, Biotechnology, Biochemistry, Cell or Molecular Biology, Biological Sciences or a related discipline.

BS with 13+ years, or MS with 11+ years, or PhD with 8+ years of relevant industry experience.

Consistent record and success in leading and executing tech transfer for early-stage and late-stage biologics programs to internal and external manufacturing facilities.

Extensive cell culture process knowledge and experience in tech transfer, development, and GMP manufacturing within the pharmaceutical industry.

In-depth knowledge of CMC aspects (timelines, key breakthroughs, functional/cross-functional knowledge, and deliverables) of biopharmaceutical development and commercialization.

Demonstrated ability and leadership in leading both the line function and matrix teams; ability to influence functional and cross-functional teams for decision-making and business process improvement.

Excellent organization, planning, problem-solving, and critical thinking skills

Excellent written and verbal communication skills.

Strong interpersonal skills and demonstrated ability to effectively work across a large organization

Preferred

Validated experience in leading technology innovation, and building high-performance teams to drive and deliver positive impact to biologics development and/or manufacturing.

Knowledge of phase-appropriate regulatory guidelines and requirements for upstream cell culture development and manufacturing including raw material and cell banking requirements

Benefits

Fitness center

Employee healthcare clinic

Electric vehicle charging stations

Dry cleaning

Full-service cafeteria

Copy center

Company

AstraZeneca

Glassdoor

4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor AB.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10,001+ employees