Chemist III - USA

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

The primary purpose of the job is to perform the testing and decides on the acceptability of the process validation samples, raw materials, finished products, stability samples, and developmental samples in a regulated laboratory environment in support of the timely disposition of manufactured products. Analyze and interpret results in written and oral format. Develop, validate and routine testing of physcial characterization methods for Nasal and inhalation drug products.

Perform routine release tests of raw materials and finished products including wet chemistry analysis, dissolution, content uniformity, assay, particle size distribution, density, water determination by KF, and other tests according to the in-house specifications and methods and USP monographs using classical wet chemistry and instrumental techniques. Perform routine tests like assays, related compounds, chromatographic purity, residual solvents, particle size distribution, Infra-red spectroscopy using different techniques and instrumentation like UV, HPLC, GC, IR etc. Evaluates test results and decides acceptability of the samples based on the test results. Reviewing and releasing of the raw data, documentation and results for certificate of analysis. Write draft technical documents like specifications, analytical methods, method verification protocols and reports, method transfer documents, investigation reports etc. Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs. Follow SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices. Maintain the laboratories with good housekeeping practices and in compliant with cGMP. Other duties related to departmental activities may be assigned by management based on situation and necessity

Job Description

Role and Responsibilities

The primary purpose of the job is to perform the testing and decides on the acceptability of the process validation samples, raw materials, finished products, stability samples, and developmental samples in a regulated laboratory environment in support of the timely disposition of manufactured products. Analyze and interpret results in written and oral format. Develop, validate and routine testing of physcial characterization methods for Nasal and inhalation drug products.

• Perform routine release tests of raw materials and finished products including wet chemistry analysis, dissolution, content uniformity, assay, particle size distribution, density, water determination by KF, and other tests according to the in‑house specifications and methods and USP monographs using classical wet chemistry and instrumental techniques.
• Perform routine tests like assays, related compounds, chromatographic purity, residual solvents, particle size distribution, Infra‑red spectroscopy using different techniques and instrumentation like UV, HPLC, GC, IR etc.
• Evaluates test results and decides acceptability of the samples based on the test results. Reviewing and releasing of the raw data, documentation and results for certificate of analysis.
• Write draft technical documents like specifications, analytical methods, method verification protocols and reports, method transfer documents, investigation reports etc.
• Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
• Follow SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices. Maintain the laboratories with good housekeeping practices and in compliant with cGMP.
• Other duties related to departmental activities may be assigned by management based on situation and necessity

Qualification and Experience

Qualifications and Education Requirements

• Bachelor’s Degree in Chemistry or related scientific field and 2+ years’ industry experience as a Chemist
• Master’s Degree in Chemistry or related scientific field and 1+ years’ industry experience as a Chemist
• Knowledge of current GMP guidance, applicable USFDA and ICH guidelines and regulatory requirements (such as USP/ICH requirements)
• Ability to make observations with instruments and analysis techniques
• Basic knowledge of instrument techniques and software for instruments like HPLC, GC, IR, KF, metrohm titrator, etc.
• Ability to carry out necessary computations and to draw and interpret graphs.
• Basic knowledge of method validation, method transfer and method verification of the analytical methods.
• Knowledge of basic to advance level of computer skills.

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

Competencies

• Collaboration
• Customer Centricity
• Developing Talent
• Innovation & Creativity
• Process Excellence
• Result Orientation
• Stakeholder Management
• Strategic Agility