Auftragsdetails

Detailed Description

Onsite 12 - Month Project in Renselaer, NY

Summary:

This role utilizes and applies scientific knowledge and techniques to perform and review assay optimization, transfer, validation and investigation for QC group for in-coming component and secondary packaging.

Scope:

• Develops and validates methods for in-coming components and secondary packaging both compendial and non-compendial.
• Supports investigations from a technical perspective for methods.
• Engages with Combination product teams to bring methods to QC Commercial before process validation, evaluates and determines the appropriate methods to bring to QC Commercial.
• Analyzes and Monitors day-to-day method performance in QC lab, including determining if problem resolution requires appropriate subject matter expert to help with any method-related issues
• Communicates method updates to partners/contract labs and tracks progress of updates. Participates in and coordinates post-transfer investigations between contract sites and collaborative partners.
• Tracks team activities and timelines to ensure that the deliverables within the project plans are met and on time.
• Escalates issues to management, as needed. Continuously drives to improve processes for improved performance.
• Supports investigational identification analysis.
• Performs and/or coordinates assay qualification for the QC Group.
• Drafts new test procedures and assays for QC Group.
• Authors and/or coordinates technical document preparation (Analytical Development Reports, Assay Validation Reports).
• Participates in training programs for QC personnel.

This role might be for you if you have:

• Ability to quickly learn and adapt.
• Ability to work independently or as part of a team.
• Ability to communicate with transparency.
• Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint). Skills at gathering and organizing information.
• Ability to follow directions and perform well-defined tasks.
• Effective time management skills.
• Excellent written and oral communication skills.
• Ability to develop strategy and create metrics to measure effectiveness of strategy.
• Ability to identify and effectively communicate risks.

• Working times:  Monday-Friday 8:00AM-4:30PM
• Minimum education requirements and major (ex. BS in Chemistry, Biology, Biochemistry): BS/BA in a Life Sciences.
• Minimum work experience requirements if any:  2 years of relevant experience in a cGMP environment or equivalent combination of education and experience. Experience with in-coming component and functional testing is desired.