Sr IT Business Analysis Specialist (Tech Dev Biologics Clinical Manufacturing)

Описание вакансии

The Sr IT Business Analysis Specialist (Tech Dev Biologics Clinical Manufacturing) in the PDM IT organization, will be a strategic technology partner to the PDM Biologics Clinical Manufacturing business capability, working with business colleagues to align technology direction with business goals and help define relevant and effective solutions while maturing existing systems and services in order to drive business value.

The Sr Specialist will be responsible for the ideation, planning, development oversight for the Biologics Clinical Manufacturing business capability. Participates in short and long-term business or IT strategic planning sessions, identifying opportunities and making recommendations for the enablement of capabilities. Participates in the analysis efforts for business case development, including resource estimates, prioritization and categorization. Advises on options, risks, costs versus benefits, and impacts on end-user, processes and system priorities. Engages and collaborates with business leadership team members, senior business stakeholders and business process owners to cultivate technology solution aligning with business or IT strategies. Establishes and maintains a strategic relationship with leadership team members and senior business stakeholders.

The role will be involved with IT solutions planning for PDM Digital Strategy initiatives through to successful execution of these initiatives. Projects may include web-based solutions (SaaS), specialized Tech Dev Biologics Clinical Manufacturing applications, extending enterprise technologies, and supporting IT Operations and Solution Delivery teams to enhance business effectiveness. Critical to the role will be championing projects and working with business teams to prioritize across initiatives. Also, works with Technical Development IT leadership in assisting in the management of the application portfolio. This role will direct both internal and a significant contingent of managed and contracted services staff to drive business outcomes.

Essential Duties and Job Functions

Business Knowledge/Relationship

• Cultivates and demonstrates a working knowledge of Biologics Clinical Manufacturing, Facilities & Engineering and Quality Control.

• Participates in short- and long-term strategic planning session to improve business or IT processes through capability development

• Participates in discovery sessions to identify opportunities for improvements in business capabilities or IT operations and formulate proposals for cost-effective solutions based on engagement, project, and operations activities

• Demonstrates how capability enablement can assist selected departments / business areas and how platforms and solutions can support the achievement of short- and long-term business or IT capability goals

• Establishes and maintains a strategic relationship with select functional level stakeholders based on experience and contribution to business operations

• Participates in the development of business use cases, cost structure, and ROI model in support of investment projects and activities to build IT Roadmap and demonstrate clarity on how solution provides business value

Strategic Planning: Business roadmap alignment to product backlog

• Actively communicates with select business capabilities, IT, vendors and other stakeholders, to ensure awareness of vision, roadmap, progress, risks, and results associated with a key capability

• Works with appropriate business Subject Matter Experts (SMEs) and business stakeholders to proactively identify and evaluate risks associated with business decisions that may impact a capability enablement

• Participates in workshop sessions for incremental roadmap assessments and business alignment

• Educates and aligns business digital vision and needs with IT initiatives, beyond technical feasibility

• Illustrates contextual insight to ensures IT development supports revenue growth, compliance, and customer outcomes

• Presents Voice of the Business by capturing evolving business needs and translates them into system capability targets

Strategic Planning: IT System Roadmap Integration

• Participates in workshop sessions for Strategic Planning to connect business objectives to long-term IT capabilities

• Provides input to anticipates changes in scale, market, or regulation to future proof and incorporate them into the roadmap

• Participates in cross-functional teams to align product, operations, and IT on a single direction

Technical Implementation: Business requirements alignment to optimized business processes

• Provides input to Business Translation Layer to ensure delivery solves business problems to enable DevOps team for code delivery

• Reduces rework by validating business requirements upfront, avoiding costly misalignment during implementation

• Enhances change management with increased adoption by ensuring workflows and training match the business context

• Works with business process owners and DevOps leads to cultivate appropriate solution required to meet business or IT objectives

• Engages Domain Architecture team to align long-term technology strategy with business objectives

• Sets proper expectations with business and supports escalation and resolution through negotiation or governance mechanisms

• Participates in analysis of current and future technology trends to determine impact to the business, provides input to IT team lead to promote capability enablement and benefit realization

• Communicates to other IT domains for awareness of key capability aspects, how they operate and how they are impacted

Operational Support: Change management and continuous value realization

• Participates in tracking business KPIs post-implementation

• Provides feedback loops for product enhancements and roadmap updates

• Provides input to ensure IT delivery remains aligned with evolving business needs

Leadership & Management

• Provides input to IT team lead to help prioritize the flow of work in program backlog

• Fosters a team environment and shares relevant information with IT team members

Experience & Skills:

• Strong communication, excellent research skills, and learning agility to understand internal business or IT process, best practices and translate into technology needs/opportunities

• Strong collaboration, stakeholder management and communication skills – including verbal, written, and negotiation

• Strong Listener. Be able to patiently listen to understand the business needs

• Strong work ethic, a sense of business urgency, and the ability to work effectively with many deadlines in a complex matrix organization

• Proven track record of critical thinking, analytical ability, operational excellence, and detail orientation.

• Possesses ability to analyze make critical decisions based on analysis

• Ability to find innovative ways to resolve problems

• Experience in stakeholder management, dealing with middle management up to executive level

• Specific experience in the Life Sciences/Pharma/Medical Devices/Healthcare industries is preferred

• Demonstrated expertise in technology environments relevant to Biotech Clinical Manufacturing production

• Experience with platforms critical to Biologics Clinical Manufacturing (e.g., MES / Electronic Batch Records, ERP Mfg, CMMS, Digital Process and Automation, Historian, IOT, etc. ) and a willingness to learn and adapt to new Biologics Clinical Manufacturing IT systems as they emerge

• Extensive knowledge of Agile methodologies and tools (e.g. Jira, Asana, etc.), with proven abilities to apply these in supporting IT solutions that meet both business needs and clinical manufacturing objectives.

• Experience in programming environments (e.g., Python, R) and cloud computing platforms (e.g., AWS), especially those relevant to data and analytics in life sciences is very desirable

• Awareness of emerging IT trends and technologies (e.g. GenAI, Digital Twin, Process Analytical Technology, AI/ML Predictive Analytics, etc.), with a commitment to continuous learning, especially in areas relevant to biopharmaceutical research.

Basic Qualifications:

• Bachelor's degree and 5+ years of relevant experience; OR

• Masters' degree and 3+ years of relevant experience

• Degree in computer science, information sciences or related field or equivalent experience.

Preferred Qualifications:

• Strong understanding of GxP compliance and 21 CFR Part 11 requirements.

• Significant IT experience in a corporate or other relevant business environment, with a strong preference for experience in the biopharmaceutical industry.

• Experience with IT implementations, integrations, cloud transformations, and understanding of data security and compliance issues in a scientific or healthcare setting.

• Knowledge of Biologics Clinical Manufacturing processes

• Highly organized, results-oriented and attentive to details, self-motivated, proactive, independent and responsive - requires little supervisory attention

• Good understanding of GxP compliance and 21 CFR Part 11 requirements

• Experience with Biologics Clinical Manufacturing is preferred

• Must be quality oriented and ensure all work streams are aligned with business, IT compliance, and cGMP regulation

• Ability to translate technical topics into business terms

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.