Define and execute purification development strategy for pivotal, commercial, and lifecycle-management biologics programs, providing technical direction for characterization, scale-up, and manufacturing support.
Compensation
The salary range for this position is: $226,185.00 - $292,710.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Responsibilities
Define and execute purification development strategy for a portfolio of pivotal, commercial, and lifecycle-management biologics programs.
Provide scientific and technical direction for process development, characterization, scale-up, validation readiness, technology transfer, and commercial manufacturing support.
Oversee development of robust and manufacturable drug substance purification processes, including harvest clarification, chromatography, virus inactivation, virus filtration, ultrafiltration/diafiltration, formulation, and final drug substance filtration.
Direct risk-based process characterization strategies, scale-down model development, process parameter evaluation, and establishment of scientifically justified process control strategies.
Provide technical support for technology transfers to internal manufacturing sites, external partners, and contract development and manufacturing organizations.
Lead and manage the purification development strategy for pivotal, commercial, and lifecycle-management biologics programs, providing scientific and technical direction across scale-up, validation readiness, technology transfer, and commercial manufacturing support.
Compensation
The salary range for this position is: $226,185.00 - $292,710.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Responsibilities
Define and execute purification development strategy for a portfolio of pivotal, commercial, and lifecycle-management biologics programs.
Provide scientific and technical direction for process development, characterization, scale-up, validation readiness, technology transfer, and commercial manufacturing support.
Oversee development of robust and manufacturable drug substance purification processes, including harvest clarification, chromatography, virus inactivation, virus filtration, ultrafiltration/diafiltration, formulation, and final drug substance filtration.
Direct risk-based process characterization strategies, scale-down model development, process parameter evaluation, and establishment of scientifically justified process control strategies.
Provide technical support for technology transfers to internal manufacturing sites, external partners, and contract development and manufacturing organizations.
Lead the creation and management of Chemistry, Manufacturing and Controls (CMC) documentation for biologic products within AstraZeneca’s Global Technical Operations.
Responsibilities
Project manage and deliver CMC content across the product lifecycle
Generate and coordinate responses to Health Authority questions
Ensure human-authored and AI-generated content is accurate and compliant
Apply project management to changing submission requirements
Maintain knowledge of biologics development and regulatory guidance
Requirements
Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Pharmacy or a related field
Nice to have: Master’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Pharmacy or a related field
Nice to have: Broader experience in biologics manufacturing, CMC, process development
Nice to have: Experience across multiple modalities such as monoclonal antibodies and antibody-drug conjugates
Nice to have: Experience applying AI tools in scientific, technical or regulatory workflows
PhD in chemical engineering, biochemical engineering, biochemistry, bioengineering, biotechnology, pharmaceutical sciences or related scientific discipline
MS with 10+ years of relevant experience
BS with 12+ years of relevant experience
Nice to have: direct people leadership experience
Nice to have: supporting pivotal or commercial-stage monoclonal antibodies, complex proteins, bispecific antibodies, antibody-drug conjugates
API LeadGE HEALTHCARE · Oslo, Norway+2 more
CMC Technical Authoring Manager – Global Technical OperationsAstraZeneca · Södertälje, Sweden