Analytical Scientist

This position will be in the Analytical Support Section of the Quality Control Department which consists of eleven team members working together to support the department goals. The main activities of the role are as follows:

• QC Test Material Management

• International Shipments

• new product support

• compendial compliance

• method transfers

• method validation

• support Assay Lifecyle Program

The main responsibilities will be to support the reference standard and critical reagent program, which includes inventory management, international shipping in compliance with Regulatory Affairs. Also support the assay lifecycle program which includes method validation and method transfers.

A key component to this role will be involvement in method transfer.

The analytical methods included for this position will be the entire company portfolio of products which includes wet chemistry methods, compendial methods, GC, LC/MS, UV, CE, AA, ICP, various other instrument methods, and cell-based assays. There is opportunity for exposure to a variety of test method techniques. The analytical and biological methods included for this position will be the entire company portfolio of products which includes wet chemistry methods, compendial methods, GC, LC/MS, UV, CE, AA, ICP, various other instrument methods, and cell-based assays.

KEY RESPONSIBILITIES:

• General Method development/optimization, method transfer and method validation

• Support Assay Lifecycle Program Management of more than 200 methods from multiple disciplines

• Inventory management of all QC materials working across multiple departments

• Manage International Shipments for QC in compliance with Regulatory Affairs and all relevant Government and Shipping company laws.

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KEY ACTIVITIES:

• Participate in project teams involved in the method transfer/validation of QC Analytical Methods

• Participate in project teams involved in the management of reference standards and critical reagents used in QC Testing

• Author and Review documents in support of the department functions

• Perform laboratory tasks in strict compliance with local documents and Federal Regulations

• Ability to manage multiple projects and work independently on assigned tasks as an individual contributor and in teams

• Maintain and optimize reference standard and reagent storage

BASIC QUALIFICATIONS:

• BS Degree in Chemistry, Biology or Microbiology (Preferred) or Science with 2 years experience in a cGMP environment. Experience with Microsoft Excel is required.