Posted 10 days ago
Description
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Responsibilities
- 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.
Required Qualifications
- 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.
Preferred Qualifications
- 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.
Seniority level
Associate
Employment type
Contract
Job function
Science, Research, and Quality Assurance
Industries
Pharmaceutical Manufacturing
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