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Astellas Pharma Director, IT & Automation in South San Francisco, California

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina.

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

  • Be BOLD (Find a Way)

  • Care Deeply -- for our patients, each other and our work

  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

As part of the Astellas Gene Therapies (AGT) Enterprise Engineering & Facilities team, the AD/Dir, IT & Automation will provide overall management (strategy, planning, coordination, execution, support) of Information Technology systems, applications, hardware, and software in use at our gene therapy research and manufacturing facilities across the US, with a focus on performance, stability, security, compliance, and data integrity. Oversees cross site automation platform advancements and enhancements in collaboration with Information Systems, Research, TechOps, and Quality team members. The AD/Dir, IT & Automation is both a strategic and tactical leader providing guidance and oversight to both direct performance and third-party services in support of these expectations. Partners with business areas to identify system requirements and translate business requirements into functional service projects, enhancements, and support. This role reports to the head of Enterprise Engineering & Facilities with dotted line reporting to the head of Global Technology Business Information Management.

Primary Responsibilities

  • Manages and supervises the activities of the team, providing mentorship, coaching, development, and reinforcing objective accountability while promoting and fostering a culture of innovation, collaboration and engagement.

  • Advance IT and automation leadership through alignment with, and reinforcement of, industry best practices while driving continuous improvement initiatives or solutions to systemic gaps and challenges.

  • System ownership of manufacturing IT and lab informatic systems and applications, and performance of computer system validation and system administration in accordance with defined procedures, and ready to present to regulatory inspectors and internal auditors during inspections and internal/partner audits.

  • Drives or supports the delivery of capital projects in accordance with the project and asset lifecycle and project management playbook, with visibility via dashboards, status reports, & meeting minutes.

  • Tracks and monitors demand, including budget and resource planning. Works with project controls and finance team members on periodic budget updates, accruals, and forecasts.

  • Coordinates and collaborates with Information Systems in support of related demand planning and cross team project support to meet agreed scope and deliverables.

  • Establishes data management, data integrity, and business continuity strategic plans. Coordinates with Pharmaceutical Technology, aligning cross division systemic opportunities, business case development, and project prioritization efforts.

  • Chairs forums focused on promoting cross site collaborations, metrics reviews, and continuous improvements.

  • Responsible for authoring and reviewing GMP/Non-GMP documentation including functional specifications, design specifications, network diagrams, change control, computer validation testing, inspection readiness, disaster recovery, and departmental support processes and procedures.

  • Executes change control processes for deployment of system/database software across GMP validated environments.

  • Oversees contractors and consultants engaged in the design, implementation, modifications, and testing of IT and automation systems, ensuring contracting, training, and vendor qualification processes are adhered. Integrates new equipment into systems while ensuring compliance. Executes testing and installation of system/database patches, upgrades, and new releases.

  • Develops enterprise policies and procedures, and oversees continuous improvement of knowledge management, audit trail reviews, code management, custom batch record reports, and systems administrations and backup at all GTCOE GMP manufacturing environments.

  • Provide guidance and assistance to resolve issues/conflicts and provide mentoring and guidance to project site team members.

  • Defines appropriate standards, policies, procedures, software toolsets, and supporting peripherals to facilitate the management, accountability, compliance, and functionality of system/databases and applications.

About you

Must Have/Required

  • BA/BS or equivalent in engineering, information systems or equivalent focus of study with the AD (D) typically having 12+ (15+) years relevant experience with a minimum of 7+ (10+) years related IT and Automation management experience

  • Proven experience with Hosted, SaaS, On-Prem applications support GxP application in a Biotechnology environment.

  • Demonstrated leadership, critical thinking skills, and ability to influence across the organization to achieve milestones

  • Expertise in regulatory compliance with respect to computer system validation and change control

  • Strong problem-solving, decision-making skills, interpersonal skills and ability to work in a team

  • Strong understanding of network connectivity and troubleshooting related application issues in a manufacturing environment

  • Excellent technical writing, verbal communication and time management skills

  • Proven experience with managing resources deployed supporting virtualized infrastructure for manufacturing and process control.

  • Excellent project management skills and substantial exposure to project-based workload and breakdown structures, software development cycles

  • Some travel will be required

  • Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

  • Experience in a facility startup and licensure environment

  • Experience with systems including PI, BMRAM, Labware, PIMS, Synergis, and Fusion a plus

  • Experience working with Quality systems in a commercial-ready gene therapy facility

  • Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet production deadlines

  • Ability to deal with ambiguity, creative and pragmatic approach to problem solving

  • Exposure of regulatory authority inspections and inspection readiness

#LI-LK

Category Tech Ops - Facilities & Engineering

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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