Job Description
You will serve as an integral member of the Global External Manufacturing Operations team and play a key role in supporting external contract manufacturing activities relating to commercial & clinical drug products. The candidate will directly support Managers/Process Team Leads who are responsible for ensuring seamless supply of products 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.
This is a 8 month contract. Hybrid Schedule 2 days in Novato, California.
Responsibilities:
- 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, inter organizational transfers 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.
- 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).
Qualifications
- Bachelor's degree
- 3-5 years in Operations, Supply Chain within a regulated environment.
- Working understanding of ERP systems (e.g. Oracle, SAP).
- 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.
Pay
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
- Medical insurance – PPO, HMO & HSA
- Dental & Vision insurance
- 401k plan
- Employee Assistance Program
- Long-term disability
- Weekly payroll
- Expense reimbursement
- Online timecard approval
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.
Job Tags
Contract work, Temporary work,