Posted 9 days ago
Description
Associate Scientist – Analytical Development & QC
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Base pay range
$40.00/hr - $40.00/hr
Job – Associate Scientist – Analytical Development & QC
Duration: 12 Months (Possibility of extension)
Role Overview
This Associate Scientist III position is a key role within external analytical development and quality control (QC) team. The candidate will support analytical efforts throughout early- to late-stage clinical programs. This includes collaborating with internal and external QC laboratories and facilitating scientific data entry for assay performance trending.
Key Responsibilities
- Capture, verify, and standardize assay performance data across platforms to support method evaluation globally.
- Collaborate with laboratory teams to refine data pipelines, enhance metadata standards, and improve assay trending workflows.
- Produce clear summaries, dashboards, and reports for stakeholders; support SOP updates.
- Verify analytical data for assay performance and assist with analytical transfer/validation reports for late‑stage clinical and commercial programs.
- Contribute to analytical method evaluation in the lab as needed.
Required Qualifications / Skills
- Hands‑on experience in developing and executing analytical methods for biological products, preferably in a cGMP environment.
- Ability to critically evaluate scientific documentation and testing data.
- Excellent written and verbal communication skills.
- Strong collaboration skills and experience working in cross‑functional teams.
- Familiarity with cGMP regulations related to analytical testing, validation, and transfer.
- Strong organization, attention to detail, creative thinking, and complex problem‑solving abilities.
- Comfortable working in a lab with biological, infectious, and hazardous materials while using proper PPE.
- Physical capability to lift/carry 15–30 pounds, work in controlled lab environments, gown/degown PPE, use computers, and communicate via phone/video/email.
Preferred Qualifications
- Bachelor’s or Master’s degree in Chemistry, Biochemistry, Molecular/Cell Biology, or related field.
- 3–6+ years of experience in a relevant analytical laboratory setting.
- Experience with JMP, electronic documentation systems, and quality management systems.
- Strong hands‑on experience in a cGMP environment.
- Comfortable working in a fast‑paced team environment.
- High proficiency in MS Office: Word, Excel, Outlook, Visio, PowerPoint.
Seniority level
- Mid‑Senior level
Employment type
- Full‑time
Job function
- Science and Health Care Provider
Industry
- Biotechnology Research and Pharmaceutical Manufacturing
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