Career Category
Information SystemsJob Description
Let’sdo this. Let’schange the world. In this vital role as Senior Manager Software Development Engineering, you will lead a dynamic team of technical product owners, software development engineers, test/validation engineers responsible for the design, development, management, and optimization of AmgenOperation’sElectronic Lab Notebook and Instrument Data Acquisition Platform. Youwill also be the reporting manager for this team and will be responsible forthe coaching and development of these resources.
The ideal candidate will have a consistent track recordof leadership in technology-driven environments with a passion for fostering innovation and excellence in the biotechnology industry. The role requires strongexpertisein ELN Applications, Enterprise Application Integration, end-to-end dataand 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 learningand knowledge management.
They should also have experience leading and effectively working withlarge, diverseand globally dispersed teams within a matrixed organization.Extensive collaboration with global cross functional teams is required toensure 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’sHolistic 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 communicationwith 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 facilitatingcommunication when service commitments are unmet.
Ensure overall organizational compliance with quality and GxPin technology services, monitoremerging 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, ITor related field OR
Bachelor’s degree with 10 - 16 years of experience in Engineering, ITor related field OR
Functional Skills:
Must-Have Skills:
Background as a Technical Product Owner (TPO), people manager, and business analyst, ensuringthe ability to oversee and guide ateam totranslatebusiness needs into definition and delivery of technical solutions, guiding development teams, prioritizing features, and ultimate deliveryand managementof the digital products.
Extensive experience designing, configuringand 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, demonstratedexperience in leading and developing a hard-working team of technologyprofessionals, building a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements.
Experience in implementing a strategicroadmap and driving transformation initiatives using ScaledAgile 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 expertisewith offerings within the Lab solution landscape - including ELN, inventory management, MESand 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 GxPsoftware 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 ofITIL 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 optimalperformance, 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.

