Senior QC Chemist - Inhalation Drug Product Analytics

Lupin Pharmaceuticals; New Jersey; On-site; USD 70,000 - 90,000; Full time

Job summary

Lupin Pharmaceuticals is seeking a Chemist to perform testing and decide on acceptability of process validation samples, raw materials, finished products, stability samples, and developmental samples in a regulated laboratory environment. Develop, validate and routine testing of physical characterization methods for Nasal and inhalation drug products.

Perform routine tests including wet chemistry, dissolution, content uniformity, assay, particle size distribution, infrared spectroscopy, and

Qualifications

• Bachelor's or Master’s degree in chemistry or related field with industry chemist experience.
• Knowledge of GMP guidance and regulatory requirements (USP/ICH).
• Ability to operate instrumentation and analyze data with integrity.
• Familiarity with analytical methods development, transfer and verification.
• Proficiency in computer software and data handling.

Responsibilities

• Perform testing of raw materials and finished products per in-house specs and USP monographs.
• Conduct routine release testing including wet chemistry, dissolution, and content uniformity.
• Evaluate and release data for COA; review documentation and reports.
• Write specifications, method verifications, transfer documents and investigations.
• Maintain accurate lab notebooks and SOP-compliant records.
• Comply with cGMP and safety guidelines; keep labs tidy and compliant.
• Take on other departmental duties as needed.

Skills

GMP Knowledge

Analytical Techniques

Lab Instrumentation

Data Analysis

Documentation

Education

Bachelor's Degree in Chemistry

Master's Degree in Chemistry

Tools

HPLC

GC

IR

KF

Metrohm Titrator

Job description

Lupin Pharmaceuticals is seeking a Chemist to perform testing and decide on acceptability of process validation samples, raw materials, finished products, stability samples, and developmental samples in a regulated laboratory environment. Develop, validate and routine testing of physical characterization methods for Nasal and inhalation drug products.

Perform routine tests including wet chemistry, dissolution, content uniformity, assay, particle size distribution, infrared spectroscopy, and