POSITION OBJECTIVE:          In this role, you will be the site Information Technology leader and will lead the infrastructure, applications and support teams for manufacturing operations and systems at our facility in Dunkirk. You will also drive the strategy to deliver highly scalable, secure, and reliable systems, platforms, and network infrastructure. In addition, you will implement governance processes, IT client communication plans, IT validation and standards for the manufacturing site. The IT manager will support the business goals of operations and develop automations strategies to build efficient compliant operations   


Essential Job Functions/Responsibilities

 

  • Oversees the IT operations vision for the manufacturing facility and ensures it is in alignment with organizational goals.
  • Designs and implements IT strategies and infrastructure for the facility; researches and makes recommendations for new products and technology as needed.
  • Ensure clear project management of all IT related projects; Capable of managing and prioritizing multiple projects at one time.
  • Directing the effective delivery of networks, development, and disaster recovery systems and processes for our operational technology systems. 
  • Working with project engineers to find solutions and manage daily operations & activities
  • Provide team leadership and guidance while working closely with facility management, external vendors and advisors.
  • Prepare budgets and presenting proposals for capital projects to facility and operational leadership.
  • Develops and maintains strong working relationships with key internal customers at all levels to understand their business drivers; works with internal customers to understand requirements and deliver/promote technical solutions as appropriate.

 

  • Ensures applications and systems adhere to policies and procedures that are compliant with industry and regulatory regulations


 

  • Leads efforts to improve IT processes.
  • Apply GMP, Safety, SOPs, discipline practices, terminology to ensure successful IT Audits.

 

·      Other projects as may be assigned.

 

 

Required Education & Qualifications

·      Bachelor degree in Information Technology, Information Systems, Computer Science, Engineering or related field; Masters degree preferred

 

·      Minimum of 10 years of experience working in IT operations, automation industry or operational technology

 

·      At least 3 years of experience is in leading IT teams and complex projects.

 

·      Management of  IT systems in a highly regulated environment (such as Pharmaceuticals) is required.

 

·      Sound understanding of computer systems, networks, security, telecommunications, databases and storage systems.

 

·      Solid working knowledge of all relevant coding languages and security protocols.

 

·      Thorough understanding of site operations technology including ERP, LIMS, automation systems, etc. 

 

·      Strong knowledge of the life cycle in a Contract Development and Manufacturing Organization (CDMO) – ie, Analytical Development, QA, QC, Manufacturing, Supply Chain


·      Understanding and ability of how to manage and support 24/7 coverage to support manufacturing and laboratory operations

 

·      Excellent written, oral, instructional, presentation, and interpersonal skills  

 

·      Strong leadership and mentorship capabilities with the ability to encourage and motivate others.

 

·      Excellent analytical and problem-solving skills



Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. 

Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.


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Do you have experience working in a FDA regulated environment?
Your primary work location is expected to be in our manufacturing facility in Dunkirk, NY with occassional travel to other sites to include Buffalo Medical Campus. Would you be willing to comply with this requirement?