Job Description

Job Description

You will be responsible for:

• Accurately, capture, verify and standardize assay performance data across platforms to support method performance evaluation across global testing network.
• Interface with laboratory teams, refine data pipelines, enhance metadata standards, and drive continuous improvements in assay trending workflows.
• Produce clear summaries, dashboards, periodic reports for stakeholders and help support SOP updates.
• Support analytical data verification for assay performance and analytical transfer/validation reports for late stage clinical and commercial programs.
• Contribute to analytical method evaluation, as needed, in the laboratory.

You will need to have:

• Strong hands-on experience in the development and execution of analytical methods for biological products, especially in cGMP environment, is a significant plus.
• Ability to conduct critical evaluation of scientific documentation and testing data.
• Excellent written and verbal communication skills.
• Excellent collaboration skills and experience working in cross functional teams.
• Strong familiarization of cGMP regulations pertaining to analytical testing, validation and transfer, and expertise in analytical laboratories.
• Excellent organizational skills, attention to details, creative thinker and complex problem solver.
• Work comfortably in a controlled environment with biological, infectious, and hazardous materials under PPE.
• The duties of this role are conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted ; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Bachelor’s or master’s degree in chemistry, Biochemistry, Molecular and Cell Biology or related discipline.
• 3-6+ years of experience working in a relevant analytical laboratory setting.
• Experience with JMP, electronic documentation and quality management systems.
• Strong hands-on experience in cGMP environment.
• Experience working in fast-paced team environment.
• High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint.

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