Jobs at BioSpace

• Engineering Leadership
• Develop and implement the site engineering and maintenance strategy aligned with CSL enterprise objectives, ensuring optimal asset performance and lifecycle management

• Own the design, performance, and continuous improvement of the product value chain, aligned to enterprise strategy and standards.
• Ensure reliable supply of quality products to patients across clinical and commercial stages.

• Design and build secureplatform capabilities using Python/TypeScript, GitHub Actions,Pulumi, Docker, AWS, and relevant internal or vendor APIs.
• Lead the design and evolution ofAI runtime safetyand AIgatewaypatterns,includingpolicy enforcement,access controls,telemetry,auditabilityand operational controls.

• Supportadministration ofPower Platformacross development,validation, and production environments.
• Support implementation and maintenance ofthe Power Platform CoE governance framework,including:

• Build and maintain automation for developer platform services usingPython/TypeScript,GitHub Actions,Pulumi, Docker, AWS,JFrog,andothervendor APIs.
• Partner with application teams to migrate workloads onto standard platform capabilities.

• Lead and oversee the design and implementation of all solutions for Digital Lab Operations Research & CMC operations. Ensure alignment with architecture strategy and adhere to governance standards
• Lead the Lab In the Loop implementation with In Silico Research organisation

• Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
• Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.

• Serve as a recognized expert in cheminformatics and applied AI/ML, who consistently delivers high-impact scientific contributions and strategies that resolve critical project challenges to advances programs through major milestones.
• Develop and apply cheminformatics, statistical, and AI/ML methods that improve hit identificati...

• Coordinate day-to-day project activities across cross-functional teams, including Research, CMC, Quality, Regulatory Affairs, Clinical Operations, and external partners.
• Develop and maintain project timelines, action-item trackers, meeting agendas, and other key project documentation.

• Administer the learning management system and related learning technologies
• Configure and maintain courses, curricula, certifications, learning paths, learner groups and assist with user profile management and access

• Provide leadership, direction, and support to the people within Quality Engineering and other departments to ensure that they are qualified to achieve a high level of competence, are motivated, and carry out their duties in a safe manner.
• Establish and maintain the site’s quality system processes related to GMP compliance of the fac...

• Serve as a strategic analytics advisor to senior commercial leadership, providing an objective and forward-looking perspective on market dynamics, business performance, risks, opportunities, and investment choices.
• Own and evolve the secondary analytics agenda for the U.S. Obesity business, ensuring that prio...

• Build and promote a strong Safety and Quality culture. Maintain a safe working environment and conduct production activities in a manner that protects safety, environment and quality.
• Participate in the creation, approval and execution of the production plan for the assigned area.

• Promote a culture of quality and operational excellence and ensure the advancement of the Company’s mission and values.
• Maintain thorough understanding of the role and responsibilities and perform duties in compliance with CFR, SOPs, cGMPs, OSHA, Safety regulations, and other rules and regulations, as applicable.

• Gérer les opérations quotidiennes de sécurité physique dans les espaces de production, d’entreposage et de laboratoire, y compris le contrôle d’accès, les rondes, la surveillance et la gestion des incidents.
• Mettre en œuvre et maintenir les procédures, consignes et standards de sécurité du site conform...

• Partner with business leaders to identify, prioritize, and activate high-value AI use cases, translating business problems into well-scoped opportunities for the teams to execute
• Act as a bridge between non-technical business stakeholders and technical teams (data science, IT, digital), ensuring AI solutions will impact both operations and strategy, allowing us to increase the speed and quality of program progression to help get medicines to patients sooner

• Lead the evolution of the software engineering organization, establishing the leadership practices, operating model, engineering standards, and talent capabilities needed to support a growing Research and CMC Development digital portfolio.
• Build and develop strong engineering leaders and senior technical contributors, enabling them t...

About The Department

The Finance & Operations department brings insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance & Operations works closely across the organization to guide enterprise-wide resource alloc...

• Review analytical data, chromatographic reports, calculations, and laboratory worksheets for completeness, accuracy, and compliance with cGMP, cGLP, ISO 17025, USP, A2LA, and internal SOPs.
• Electronically sign off on data as both author and reviewer, following established procedures to ensure data integrity and regulatory compliance.

• Ensure center is “inspection ready” at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center.