Job Description:
This is what you will do:
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.
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.
