Director Operations Technology

Amgen
Holly Springs, United States of America
2 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English
Experience level
Intermediate

Job location

Remote
Holly Springs, United States of America

Tech stack

API
Artificial Intelligence
Information Systems
Data Integrity
Network Security
Systems Architecture
System Testing
Software Library

Job description

Join Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Director Operations TechnologyLiveWhat you will doLets do this. Lets change the world. In this vital role you will be part of Amgen's most technologically advanced drug substance manufacturing plant. The facility continues to expand in size and advance with embedded new technologies and industry 4.0 capabilities facility wide.

  • Responsible for providing and advancing manufacturing technology platform-specific implementation practices and standards on systems architecture, software libraries, and system lifecycle management in alignment with Operations Digital strategy and Industry 4.0 technology principles.
  • Manage Contract staff to deliver technology services using and improving the Global Solutions Delivery Model and Business Practice. The Capital portfolio spans across multiple functions; Process Development, Manufacturing Clinical & Supply Chain, and Commercial areas and includes a mix of facility expansions, systems upgrade and new construction projects.
  • Client executive relationship management responsibility with Amgen Corporate Engineering executives for Capital Projects as primary client, as well as site business executives as partners of the delivered systems and solutions. The candidate must be able to influence the development of business area strategy where appropriate.
  • Deliver the Drug Substance (DS) technology roadmap for Amgen and advance the digital maturity end to end throughout Amgens Manufacturing network
  • Lead the execution of a varied portfolio of IS and Automation projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio.
  • Shaping Amgen's future Keep track of industry and technology trends, connect and cultivate external networking opportunities to deliver valuable insight from other similar professionals in our industry.
  • Effectively maintain relationships with IS service owners, business partners, enterprise IS service partners, and vendors
  • Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by utilizing technical, project management, and business expertise.
  • Performs cross system assessments, feasibility analysis, scope projects, prioritize projects, and provide efficient solutions. Manage multiple initiatives and priorities simultaneously.
  • Accountable to elicit and analyze needs identified by business customers and convert them into functional design.

What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The technology professional we seek is an inventor with these qualifications

Requirements

  • Doctorate degree and 4 years of Information Systems experience OR

  • Masters degree and 8 years of Information Systems experience OR

  • Bachelors degree and 10 years of Information Systems experience AND

  • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources, * 15 + years experience providing process automation and information systems solutions and support to manufacturing organizations in the biotechnology or pharmaceutical industries.

  • Candidates will have worked on process automation systems and completed projects of small to large sizes in cGMP regulated manufacturing environments, preferably both in Bulk API and Formulation/Fill/Finish facilities and will be knowledgeable regarding FDA cGxP and 21 CFR Part 11 regulations and understand software system validation.

  • Expertise on the following platforms: DeltaV, Werum, Systech, Laboratory systems, IS infrastructure and Industry 4.0 technologies

  • Expertise in Automation, Data Integrity, Network Security Systems (implementation, network solutions, regulatory trends) and experience dealing with regulatory agencies

  • Exposure to sophisticated technologies around AI, Process Analytical Technology, Advance Process Control, AR/VR, Location tracking, Control tower, IIoT and electronic Instrument Data Acquisition.

  • Energetic, innovative and technically minded individual!

  • Demonstrate ability to lead and influence multi-functional teams and embrace a team-based culture.

Benefits & conditions

What you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

About the company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together-to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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