The ideal candidate will have a consistent track record of leadership in technology-driven environments with a passion for fostering innovation and excellence in the biotechnology industry. The role requires strong expertise in ELN Applications, Enterprise Application Integration, end-to-end data and process harmonization, as well as handling the seamless integration of Lab Instrument data to various enterprise business applications. This individual will manage key vendors and partner with stakeholders orchestrating the implementation of solutions that enable next generation lab processes including simulations, machine learning and knowledge management. 

They should also have experience leading and effectively working with large, diverse and globally dispersed teams within a matrixed organization. Extensive collaboration with global cross functional teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle, technical product ownership, business analysis, be a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure. 

Roles & Responsibilities:  

• Own, manage, and support Operations Enterprise Lab Information Management solutions, including Biovia’s Holistic Lab ELN Platform. 

• Provide lab systems roadmap for Amgen Operations, collaborating with IS Architects, Infrastructure Leads, and Business Analysts to develop roadmaps supporting organizational priorities and platform improvements. 

• Lead implementation of digital lab initiatives, providing experiment design, authoring, and execution solutions. 

• Align business processes with Holistic Lab, PLM, and Big Data technology capabilities by working with cross-functional representatives across Operations and sites. 

• Guide project teams on developing approaches for addressing business needs and presenting business cases for proposed solutions, while overseeing vendors and contractors to ensure deliverables. 

• Maintain strategic relationships and strong communication with the leadership team, ensuring all collaborators are informed and engaged. 

• Oversee the software development lifecycle, ensuring best practices in development, testing, and deployment across product teams, and lead large, diverse teams within a matrixed organization. 

• Develop and implement strategic plans for technology and workforce growth, including recruiting top talent and building a robust team in India, while fostering a culture of collaboration, innovation, and continuous improvement. 

• Collaborate with Platform Owners, Product Owners, Service Owners, and delivery teams to ensure delivery matches commitments, acting as a critical issue point and facilitating communication when service commitments are unmet. 

• Ensure overall organizational compliance with quality and GxP in technology services, monitor emerging technologies and trends for platform growth, and ensure ongoing alignment with strategy, compliance, and regulatory requirements. 

Basic Qualifications: 

• Master’s degree with 8 - 12 years of experience in Engineering, IT or related field OR  

• Bachelor’s degree with 10 - 16 years of experience in Engineering, IT or related field OR 

Functional Skills: 

Must-Have Skills: 

• Background as a Technical Product Owner (TPO), people manager, and business analyst, ensuring the ability to oversee and guide a team to translate business needs into definition and delivery of technical solutions, guiding development teams, prioritizing features, and ultimate delivery and management of the digital products. 

• Extensive experience designing, configuring and coding software including custom development and commercial software packages using APIs, while working within an Agile Environment and contributing to ceremonies  

• Experience with integration standards, including Web Services, SOAP, REST  

• Skilled with object-oriented design/development and semantic web standards  

• Experience with development languages such as Java, Python, Pipeline Pilot, C# a plus  

• Ability to learn new software, troubleshoot and display critical thinking techniques within improvements  

• Strong database management experience with SQL RDBMS and SPARQL; working with Big Data integration and Analytics a plus  

• Experience integrating solutions with ERP, and MES platforms is a plus  

• Proven experience and involvement in Enterprise Projects targeted for process reliability of manufacturing and product life cycle as well as streamlining end-to-end data flow and agile execution of critical operational workflows.  

• Proven leadership skills with the ability to lead large matrixed teams. In addition, demonstrated experience in leading and developing a hard-working team of technology professionals, building a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements. 

• Experience in implementing a strategic roadmap and driving transformation initiatives using Scaled Agile methodology. 

• Strong skills in collaborating and communicating with cross-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. 

• Degree in Computer Science, Information Systems, Engineering, or Life Sciences. 

Good-to-Have Skills: 

• At least 5 – 8 years of domain knowledge in health and/or life sciences combined with Information Technology 

• Understanding and applied experience in Lab Informatics and cross functional data harmonization  

• Good overall understanding of business, manufacturing, and laboratory systems common in the process manufacturing as well as the integration of these systems through applicable standards  

• Up-to-date knowledge of vendor’s software strategy, information of available competing solutions and the ability to translate these to the changing business environment in PD such that we can continually maximize software investments.   

• Experience managing a globally distributed enterprise application platform  

• Solid depth or breadth of expertise with offerings within the Lab solution landscape – including ELN, inventory management, MES and scientific analysis tools  

• Leadership experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for GxP software validation. 

• Experience directing solution design, business processes redesign and software implementation in a drug development lab / commercialization environment  

• Understanding of FDA regulations governing computer system validation and operation in biotech manufacturing and laboratory areas 

• Strong analytic/critical-thinking and decision-making abilities. 

• Demonstrated ability to work effectively in a fast-paced, dynamic environment. 

• Extensive experience in the software development lifecycle. 

• Experience using and adoption of Scaled Agile Framework (SAFe) 

• Understanding of ITIL processes and implementation. 

• Established business partnerships and IS governance practices involving senior business stakeholders 

• Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products. 

Soft Skills: 

• Excellent leadership and team management skills. 

• Strong transformation and change management experience. 

• Ability to work effectively with global, virtual teams.  

• Excellent analytical and troubleshooting skills.  

• Ability to manage multiple priorities successfully. 

• Strong presentation and public speaking skills. 

• Strong verbal and written communication skills. 

• High degree of initiative and self-motivation.