Staff IT Project Manager

Position Overview

This is a key position in the application implementation groups of the Nektar IT organization.

As such, this position will be responsible for the management of the implementation of critical systems for Nektar's various departments (Research, Drug Development, PDM, Finance, HR, Quality, Supply Chain, etc.) departments. This position will also serve as an IT liaison to the business and will translate their business requirements into technical solutions and processes. This position will manage multiple projects and will collaborate closely with various business departments, cross-functional teams and our SaaS vendors. Finally this position will provide leadership in system delivery/implementation, regulatory compliance (SOX, GxP, etc) within Nektar's SLC framework, tools and procedures. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results. Creates formal networks involving coordination among groups. Develop project plans, organizes and leads project teams, monitors progress and drives the delivery with focus on adhering to schedule. Facilitate sessions for use-cases, requirements gathering and configuration workshops, as necessary. Develop or review the necessary documentations (e.g. CaPEx, Statement of Work, Service Level Agreement, Stakeholder Requirements, Functional Requirements, detailed schedule and budget and necessary SOP's). Lead and monitor the planning, deployment or required upgrades of Nektar systems, in support of Nektar's stated business objectives. Drives and coordinates system related Change Requests, Deviations / CAPA's and audits in accordance to governing SOX and GxP procedures. May participates in product evaluations (RFP/RFI), vendor selection, negotiates price and support options, and fosters vendor partnerships. Responsible for maintaining the validated and compliant state of all applications to ensure compliance to regulatory standards. Coordinates implementation of enhancements/upgrades and provides backup for other IT SME's as required. Responds to critical issues during off hours when necessary. Work closely with the IT platform leads to apply standards and evolve process to ensure solutions abide by best practices and industry standards. Other duties as assigned.

A minimum of a Bachelors' degree in Computer Science, Information Technology, or related discipline. is required. An advanced degree is highly preferred. Equivalent experience may be accepted. Certification in Project Management is preferred. A minimum of 12 years project management experience is required. A minimum of 8 years of GxP Project implementation experience required. Strong knowledge of procedures/ best practices related to FDA Regulations, SOX, EU GMP Annex 11, 21 CFR Part 11, Computer System Validation, GAMP 5, cGxP (cGCP, cGLP, cGMP) practices required. Familiar with system lifecycle (SLC) experience in a regulated environment. Familiar with Operating Systems, Infrastructure, VMWare Virtualization, and cloud-hosted technologies. Ability to articulate technical problems and business value to a wide business audience. Ability to troubleshoot issues and work independently with minimal supervision. Must be able to demonstrate strong analytical and problem-solving capabilities. Detail oriented and an Hands-on PM driving successful delivery of projects ensuring positive customer satisfaction. Excellent oral and written communication skills are required. Must possess and demonstrate strong leadership, influencing and organizational skills. Self-motivated with high degree of initiative and excellent follow-up skills.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.