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Manager, R&D Systems, Serialization and Biologic Systems
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Position Number: 2511586
Location: Raleigh, NC
Position Type: Business and Financial Management

Manager, R&D Systems, Serialization and Biologic Systems
United States - North Carolina - Raleigh

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

The Gilead Business Services center in Raleigh's Research Triangle region will be home to some of the company's critical shared service teams in North America, including Information Technology, Global Financial Solutions, HR Operations and Procurement Services Desk. These functions provide the necessary support to ensure Gilead's business runs effectively and efficiently. The center will also be a catalyst for standardization of processes, digital transformation and technology optimization. Please check out more at https://nccareers.gilead.com/

Specific Responsibilities and Skills

The R&D / PDM group within IT department is responsible for working with functional business partners in the design, build, deployment, and support of business applications globally related to Serialization and Biologics of commercial products for large, enterprise-wide programs, Technology personnel work in conjunction with the DevOps Lead and Capability manager against project objectives and have measured outcomes- typically leading the applications-related technical workstreams. R&D / PDM group also works closely with other cross-functional groups within IT namely Security, Worldwide Infrastructure Operations, and Enterprise Platform teams in the delivery of these capabilities leveraging Systems Life cycle (SLC) methodologies. This provides the mechanism for ensuring consistency and repeatability in how applications are delivered across the enterprise. The Manager, R&D Systems, Serialization and Biologic Systems role specifically requires strong management and leadership experience to work with capability managers and functional business partners in the design, deployment, and support of business applications supporting the Regulatory space within the Development Organization. This role is primarily delivery-focused role, is responsible for the technical integrity of delivering application projects while providing technical guidance to business customers and IT project team members. The position has day-to-day lead accountability and leads the project delivery and Operations from a technical solution perspective supporting Quality functional areas and works with IT DevOps Lead, Domain Architecture, PMO/other cross-functional groups within IT to perform evaluations and feasibility reviews of business need and/or technology solutions supporting the Commercial and Clinical Manufacturing business in areas such as Serialization, Biologics, Manufacturing, Packaging and distribution of Gilead products.

Essential Duties and Job Functions

The General responsibilities for the Manager, R&D Systems, Serialization and Biologic Systems will include (but are not limited to) the following:

Partner with capability manager and global capability lead and Portfolio lead to create the business case and Deliver the Projects to support Business strategy.
Partner with Implementation Vendor to ensure the effective execution of the projects and services, holding them accountable to project scope, SLAs and KPIs.
Partner with the capability manager to capture, analyze and document functional requirements Specifications
Translate business requirement to functional requirements and communicate them to technical teams
Create/update and review system related documents including validation deliverables primary business areas of focus; Develops subject matter expertise within junior IT staff in overall serialization solutions (SAP ATTP, Axway, TraceReady, Systech and Antares) and its integration with rest of ERP/GEM ecosystem to drive ongoing enhancements, upgrades and integration effort across Biologics and Serialization domains.
Provide technical guidance to local support team as well as work with Managed Services partner for Serialization and Biologics sustainment related activities
Provide Support for technical implementation activities during functional requirements and design, cost and timeline estimation, and assist in the management and communication to Gilead's stakeholders.
Participates in business customer idea elaboration and technical problem-solving with potential technical options including proposals, front-end studies, development plans, and presentations, as directed in a consulting role
Accountable for working with Business Process Owner, IT Compliance (for non-GxP systems) or QA (for validated systems) to identify the appropriate System Life Cycle model based on applicable regulatory requirements before presenting estimates for input to new system business case or change implementation plans
Leads or assists with scoping, identification of project deliverables, project time estimations, resource level estimations and ensure that the creation of project-specific documentation such as technical specifications are produced
Defines technical strategies by performing evaluations, proof of concepts and assessments on the various technical aspects of the proposed project solution
Owns the delivery of the overall technical workstream or one or more technical modules of the project under development by leading and managing the technical delivery team Understands the end-to-end technical architecture for the solution being developed. Acts as a point of technical escalation and resolution during the project lifecycle as it relates to technical decisions
Determines and provides the necessary level of technical documentation during requirements gathering, based on technical services standards and procedures and discussions with the project team and technical vendors
Partners with Project Managers (PMs) to develop the technical delivery work plan and schedule and ensures that appropriate technical delivery staffing resources are assigned, and effectively utilized. Works with the Project Manager, BPO, IT
Compliance (for non-GxP systems) or Validation Lead (for validated systems or qualified infrastructure) to ensure that the project plan reflects the dependencies and required deliverables of the selected System Life Cycle model
Communicates proactively with the Project Manager and project team regarding project status
Partners with Quality Assurance (QA), IT Compliance and Validation resources to consult and review test plans and validation plans and ensure that issues are properly assigned, fixed, and regressed
Ensures formal technical and technical performance reviews are conducted and provides feedback and suggestions
Ensures that training design documentation and delivery from a technical perspective are in place
Participates in the creation of Request for Proposals (RFP) from a technical perspective.
Ensures that project knowledge transfer occurs between project engineers and operational support staff
Facilitates creation of control for all non-GxP and GxP change requests to meet compliance requirements
Partners with external business partners to meet the technical project needs as appropriate
Works with the project software vendor(s) technical teams to ensure adequate solution design
Provides technical consulting and mentorship to coach, train and guide new or junior IT staff, such as to suggest training course options
Serves as an advocate and endorses and enforces technological best practices in collaboration with solution architects
Facilitates and coordinates technical guidance to IT senior staff, working closely with solution architects and engineers
Ensures that technical delivery complies with architecture and technical standards
Develops, documents, and shares technical delivery best practices.
Keeps abreast of industry trends and advancements in relevant technology
Consultative role on technical support areas, working closely with the System Manager
Responsible for vendor management and leading external implementation resources partnering with Gilead towards the delivery of PLM systems and/or other commercial manufacturing projects.
Support Validation/QA teams on ensuring GxP compliance of commercial supply chain systems with the corporate standard for IT change management and IT SOPs following 21 CFR Part 11 and Annex 11 requirements.
Excellent interpersonal, communication, and business partnering skills
Strategic mindset with a strong analytical foundation
Participate in cross functional business and scientific initiatives as the MS&T representative, and effectively collaborate and influence cross-functional partners to support MS&T objectives for Biologics business functions
High level of personal integrity consistent with Gilead's core values
Ability to translate complex technical issues into business terms
Excellent analytical, problem-solving, and troubleshooting skills
Advises clients/business analysts on discrete technology-related business problems, leveraging appropriate IT colleagues and/or vendors as appropriate. Formulates options including assessing their relative merits and risks, and works with clients/business analysts to determine the best solution
Supervise a team of technical professionals, with full responsibility for performance management
Acts as a technology mentor to team members

Basic Qualifications:

Associates Degree and Twelve Years Experience OR Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience
Preferred Qualifications:

Experience in general Pharmaceutical industry in R&D area business processes covering Research to Release (R&D) and PDM (Tech. Operations)
Hands on experience with implementation of Serialization domain in a Bio-pharmaceutical industry.
Hands on experience in managing complex manufacturing execution systems including tech transfer/scale-up, process characterization, process validation of biological products.
Detailed understanding of Serialization applications such as SAP and Axway ATTP ,Trace Ready, and Systech.
Experience working with L4 systems like Oracle ERP, SAP S4, SAP ATTP with ICH, Axway and integration systems like Dell Boomi Middleware along with insights to Biologics
Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing strongly desired
Good understanding of GxP compliance and 21 CFR Part 11 requirements
Laser-focused and strong delivery experience managing large, complex projects
Must think ahead strategically and must be able to weigh and decide between implementing new functionality by configuration vs assessment of new technology
Has a strong working understanding of installed systems, with the ability to troubleshoot and resolve any problems on the existing system(s) supported and is aware of integration points with other systems
Demonstrates proficiency with one or more technology environments, with the ability to learn and apply new and emerging concepts very quickly
Experience in managing complex manufacturing execution systems including tech transfer/scale-up, process characterization, process validation of biological products is desirable
Good understanding of Serialization Master Data, Analytics and planning tools
Good understanding of line level packaging systems SYSTECH and ANTARES is desirable
Must think ahead strategically and must be able to weigh and decide between implementing new functionality by configuration vs assessment of new technology
Must have 4+ years of SAP ATTP, Solution Design, implementation and integration experience with ERP (such as Oracle and SAP) and packaging execution systems (such as Systech or Antares)
Good knowledge on Capacity & Planning, Data Modelling, Data Integration, Production Scheduling, Multi-geography System Integration and solution design (SAP ERP with ATTP ICH, Orchestrate,)
Experience with Agile, Scrum methodologies and DevOps. , Cloud certification is a plus
Application development using Salesforce and Appian experience is a plus
Experience working with Computer System Validation in a GxP regulated area
Deep understanding of Clinical Trials business processes like study management, protocol development, site management, needs of different trial phases, clinical site constraints, manufacturing and CMO constraints, etc.
Experience in GxP applications (and Good Documentation Practices) and working in SOX audited environments is a plus
Process development and operations experience/expertise in upstream biopharmaceutical manufacturing processes including seed expansion operations, single-use and stainless-steel bioreactor operations, fed-batch/perfusion processes, harvest operations, basal media formulation, etc.
Experience working with SaaS applications and monitoring service levels and deployment schedules
Experience leading consultants for delivery and sustainment and ensuring the quality of work you're doing
Experience handling Change control processes as a gatekeeper
Experience with dynamic Supply Chain implementations in fast-growing companies with manufacturing and a proven track record in delivering complex projects
Implementation experience with Planning, Inventory Management, manufacturing, and international business structures
Professional written, verbal, & interpersonal skills
Ability to multi-task effectively & work independently
Strong Delivery skills, ability to work in a complex environment and an ability to influence cross-functional teams
Strong communication skills are a must
Experience working with SaaS applications and monitoring service levels and deployment schedules
Experience managing a large group of consultants for delivery and sustainment and ensuring the quality of deliverables
Experience managing change control processes as a gatekeeper
Bridges gap between business and IT, for small/ simple IT systems and projects
Track record working in a fast-paced, highly iterative environment
Strong Listener: Be able to patiently listen to understand the business needs
Communication - Should be able to communicate with business stakeholders and be able to communicate complex solutions and value in business terms. Verbal communication skills are critical and the ability to adapt and learn to changing business environment and domains is a must
Experience in Life Sciences is a must

For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

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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.

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