myGwork - LGBTQ+ Business Community · 2 days ago

Head of Small Molecule and ASO Engineering

Research Park, CA

Full-time

Onsite

Director

15+ years exp

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Responsibilities

Own strategic technical direction for all types of assets within the assigned subject matter area.

Develop intentional collaborations with external stakeholders and industry peers.

Serve as an innovation catalyst within Biogen by acquiring cutting edge knowledge in small molecule and ASO engineering.

Lead execution of small molecule and ASO engineering activities supporting capital projects.

Partner with site & external manufacturing to provide technical support and compliance oversight.

Oversee a team of small molecule, ASO, and industrial engineering professionals.

Qualification

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Process EngineeringBiotechPharmaSmall MoleculeASO ModalitiesAsset Lifecycle ManagementEngineering Best PracticesReliability EngineeringEngineering Document ManagementComputerized Maintenance ManagementCommissioningQualificationValidationFDA RegulationsEMEA RegulationsData AnalyticsInfluenceProblem-Solving

Required

BS in Chemical Engineering or related process engineering discipline

A minimum of 15 years’ experience in Process Engineering in Biotech, Pharma or equivalent industry

Expert knowledge of small molecule and ASO modalities including asset lifecycle management practices within those modalities; specifically, engineering / facility best practices, reliability engineering, engineering document management, computerized maintenance management, and commissioning / qualification / validation

Expert knowledge and application of FDA and EMEA regulations

Advanced ability to influence individuals at both site and global level

Expert understanding of asset lifecycle data analytic concepts and methods