Chemist

Job Title: Chemist

Location: North Chicago IL 60064

Duration: 12 Months

Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or combination products to ensure business objectives are met with regards to on time delivery of product while assuring compliance with local, divisional, and corporate policies and external agency regulations worldwide.

Products include Intermediates or Drug Products produced by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Grade is commensurate on level of overall responsibility.

* Supports the primary quality lead with management oversight for project activities at TPM and the team members (within and outside) to achieve on-time quality deliverables. Driver for the quality and compliance aspects of product packaging transfers.

* Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, and combination products produced at third party manufacturing (TPM) facilities. Implements agreed strategy.

* Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, liquid, solids, and/or device products and elevates medium and high risk events to management.

* Establishes and maintains relationships and open communication with Third Party Manufacturers, affiliates and other functional groups to maintain roles and responsibilities.

* Communicates and negotiates with external companies' quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide with the agreed service.

* Provides support for quality audits. Supports pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.

* Supports the management of exception documents and Corrective and Preventive Actions.

* Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.