QA/R&D Analytical Chemist I — Method Transfers & QC Insight

Tris Pharma, Inc.; New Jersey; On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

bonus eligible

medical

dental

vision

Rx insurance

401K with match

life insurance

paid Company Holidays

PTO

Paid Volunteer Time

Employee Resource Groups

Job summary

Tris Pharma, Inc. in Monmouth Junction, New Jersey, is seeking a QA R&D Analytical Chemist I to support QC and AR&D activities in a cGMP environment.

The role includes method improvements, verification, change controls and residual solvent, impurity and nitrosamine risk assessments using HPLC/UPLC, GC and UV/Vis. Candidates should hold a Bachelors in Chemistry with 3+ years in a cGMP lab or a Masters with 1+ year, be fluent in English, and capable of independent and collaborative work.

Qualifications

• Bachelor's degree in Chemistry or related science field with 3+ years in a cGMP lab.
• Master's degree in Chemistry or related field with 1+ year in a cGMP lab.
• Hands-on experience with analytical instrumentation in pharma settings.
• Proficiency with Microsoft Office.
• Fluent in English (written and verbal).
• Ability to work independently and in a fast-paced, matrixed team.
• Ability to identify and distinguish colors.
• FDA/ICH guidelines familiarity preferred.

Responsibilities

• Perform testing of raw materials, IP, FP and ST samples according to methods.
• Prepare and revise SOPs, specifications, verification protocols and change controls.
• Assist with method transfers and risk assessments for residual solvents and impurities.
• Operate instruments (HPLC/UPLC, GC, UV/Vis, IR, dissolution) in a regulated lab.
• Collaborate with R&D on analytical method transfer studies and issues.
• Maintain lab cleanliness and safety compliance.

Skills

Analytical instrumentation

Microsoft Office

Communication skills

Team collaboration

Analytical thinking

Time management

English fluency

Color vision

Willingness to work extra hours

cGMP knowledge

Education

Bachelor's in Chemistry

Master's in Chemistry

Tools

HPLC/UPLC

GC

UV/Vis

IR

Malvern Mastersizer

Dissolution tester

Empower software

Job description

Tris Pharma, Inc. in Monmouth Junction, New Jersey, is seeking a QA R&D Analytical Chemist I to support QC and AR&D activities in a cGMP environment.

The role includes method improvements, verification, change controls and residual solvent, impurity and nitrosamine risk assessments using HPLC/UPLC, GC and UV/Vis. Candidates should hold a Bachelors in Chemistry with 3+ years in a cGMP lab or a Masters with 1+ year, be fluent in English, and capable of independent and collaborative work.