Job Description
- This Associate Scientist III (Contractor) will be a key team member in the client’s external analytical development and quality control team.
- The candidate will support analytical efforts from early stage through late-stage clinical programs.
- This position will work closely with internal and external QC laboratories facilitating scientific data entry for assay performance trending purposes, support external testing oversight and work with team members to facilitate laboratory investigation closure within the quality system.
- 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.
- Support external QC testing oversight with timely communication and closure of quality records within the quality system.
- Bachelors 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.
- 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 generally 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.
- 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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