GEO Operations Support

3 days ago

Novato, United States Planet Pharma Full time

**CANDIDATES MUST LIVE NEAR NOVATO, CA OR IN PACIFIC STANDARD TIME ZONE**

12 Month Contract (May extend or convert to permanent)

$43/hour W2


Company Details:

This company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. The company will continue to focus on advancing therapies that are the first or best of their kind

The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain the company's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

The GEO Operations Support role will serve as an integral member of the Global External Manufacturing Operations team who have responsibility for and play a key role in supporting external contract manufacturing activities relating to commercial & clinical drug products

He/She will directly support the GEO Operations Managers/Process Team Leads who are responsible for ensuring seamless supply of product(s) from the contract manufacturing organizations (CMO). This candidate will be required to work across a number of multi-modality process teams to manage and execute ERP, QMS transactional activities as well as other support tasks. The GEO Operations Support role will report to the Head of Operations, GEO.


Position Details:

  • Provide direct support to Process Team Leads across Clinical, Small Molecules, Biologicals, Packaging operations on targeted/prioritized activities.
  • Manage and execute all transactional ERP aspects for production efforts at CMOs (includes executing production transactions, updating work order dates, receipting of purchase orders, etc.)
  • Own and manage prioritized change controls within the Quality Management System (QMS) to effective on time closure and no impact on supply.
  • Consolidation and issuance of key performance metrics per Process Team
  • Provide back-up support for Process Team Leads where necessary.
  • Support selected continuous improvement activities aligned to the site business plan objectives with clear and measurable time and money savings.
  • Work cross-functionally to perform rigorous root cause analysis, to understand issues and implement corrective actions as appropriate.
  • Document key business processes in a standard format (e.g., Best Practice Document or Standard Operating Procedure).
  • There may be a need for this person to execute operation tasks with a view to eliminating or reducing the number of touchpoints associated with a task.
  • This list of support responsibilities may change depending on business needs and employees are expected to be adaptable and flexible where this need arises.


Education, Experience and Skills:

  • Bachelors Degree
  • Minimum requirement of 3-5 years in Operations, Supply Chain within a regulated environment.
  • Relevant 3rd level qualification.


Required skills needed to accomplish the responsibilities/essential functions include:

  • Will have a working understanding of ERP systems (e.g. Oracle, SAP)
  • Will have a good working understanding of the processes/unit operations assigned to the team.
  • Ability to engage cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.
  • Experience in lean/six sigma/continuous improvement tools and techniques.
  • Excellent written and verbal communication skills.
  • A high level of initiative and drive, as well as excellent organizational skills, are key role requirements.
  • Ability to work independently.

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