Sr IT Business Analysis Specialist (PDM Biologics Clinical Manufacturing)

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

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.

The salary range for this position is: $126,820.00 - $164,120.00. 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. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com  for assistance.

For more information about equal employment opportunity protections, please view the  'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.