Associate Scientist- Analytical Development and Quality Control

Planet Pharma; New Haven (CT); On-site; USD 48,216 - 55,104; Full time

Job summary

A leading pharmaceutical company is seeking an Associate Scientist for Analytical Development and Quality Control in New Haven, CT. This mid-senior level contract role involves capturing and analyzing assay performance data, collaborating with lab teams, and supporting method evaluations. Ideal candidates will have a degree in chemistry or a related field and significant experience in a cGMP environment. Salary ranges from $35.00 to $40.00 per hour.

Qualifications

• Strong hands-on experience in the development and execution of analytical methods for biological products.
• Ability to conduct critical evaluation of scientific documentation and testing data.
• Experience working in a relevant analytical laboratory setting, preferably in the pharma/biotech industry.

Responsibilities

• Capture, verify, and standardize assay performance data to support evaluations.
• Interface with laboratory teams to enhance data pipelines and metadata standards.
• Produce summaries, dashboards, and periodic reports for stakeholders.

Skills

Analytical method development

cGMP regulations

Data analysis

Communication skills

Collaboration skills

Education

Bachelor’s or master’s degree in chemistry or related field

Tools

MS Office (Word, Excel, Outlook, Visio, PowerPoint)

JMP

Job description

Associate Scientist- Analytical Development and Quality Control

$35.00/hr - $40.00/hr

12-month initial contract

You will be a key team member in 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 a 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 familiarity 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, preferably in the pharma/biotech industry (less years needed for higher degree).
• 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

Mid‑Senior level

Employment type

Contract

Job function

Science and Research

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing