Chemist C

Aurobindo Pharma USA, Inc.; South Brunswick, Northern (NJ, KY); On-site; USD 85,000 - 90,000; Full time

Benefits offered by this job

Medical plans

Dental benefits

Vision plan

Life Insurance

Disability Insurance

HSA

401(k) Plan

EAP

PTO

Job summary

Aurolife, a pharmaceutical division, seeks a Chemist-C to perform QC testing and support regulatory-compliant analytical workflows. You will work on HPLC, GC, UV-Vis and other methods, plan reagent inventories, and ensure timely completion of tests.

The role includes mentoring newer chemists and contributing to a compliant, efficient lab environment. The ideal candidate holds a BS in a scientific field (Chemistry preferred) with 4–6 years in pharma and 3–5 years in analytical testing, plus 3

Qualifications

• Knowledge in Good Documentation practices and USP/ICH/FDA standards.
• Ability to learn quickly and make decisions.
• Attention to detail and accurate documentation.
• Proficiency with Empower and LIMS systems.
• 2–4 years of experience handling Out Of Specification investigations.

Responsibilities

• Perform sampling and QC tests on raw materials, APIs, in-process and finished products using wet chemistry and instrumental techniques (HPLC, GC, UV-Vis, IR, etc.).
• Plan and inventory reagents to support testing and ensure timely execution.
• Execute testing to meet established timelines; perform complex testing with supervision.
• Record data and results per procedures; maintain clear documentation.
• Prepare and review Test Procedures, SOPs, and Protocols.
• Maintain and calibrate laboratory instruments with supervision.
• Troubleshoot and investigate under supervision.
• Comply with regulatory and internal requirements (cGMP, cGLP, safety, waste).
• Review analytical documents as required.
• Assist in training and mentoring new chemists.

Skills

Good Documentation practices

USP/ICH/FDA knowledge

Empower and LIMS

Attention to detail

OOS investigations experience

Education

BS in science

Chemistry preferred

Job description

Division Overview

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced managementteam with expertise in manufacturing, R&D, Quality Assurance and Qualitycontrol and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.

Job Overview

Chemist-C will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. The Chemist-C will work as a member of team to effectively plan and QC analytical testing using established (official and/or in-house) test procedures. The Chemist may execute 90% - 100% of their work at the bench level. Chemist-C will function as a mentor and assist in training new recruits.

Responsibilities

• 1. Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.
• 2. Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
• 3. Independently plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.
• 4. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.
• 5. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.
• 6. Perform maintenance and calibrations of laboratory instruments/equipments with supervisory direction/training.
• 7. Perform troubleshooting and investigations under the direction of a supervisor.
• 8. Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
• 9. Review of Analytical documents as required.
• 10. Active involvement in training and qualification of newly hired chemists.
• 11. Be a role model and mentor to lesser experienced analysts in the team.

Qualifications - Skills & Requirements

• Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
• Ability to learn quickly and decision making skills
• Attention to detail and documentation
• Proficient in working with Empower and LIMS.
• 2-4 years of experience with handling Out Of Specification investigations.

Education & Experience

• Minimum BS within Scientific field
• BS with Chemistry is one of the subjects would be preferable
• Minimum 4-6 years experience in pharmaceuticals and must have 3-5 year experience in Analytical testing
• 3 years QC experience in Generic Pharmaceutical industries would be preferable

Benefits

• Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
• Dental Benefits with three dental plan options through CIGNA
• Vision Plan with two plan options through VSP
• Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
• Disability Insurance, Voluntary Short-Term Disability and State Disability
• Long-Term Disability (LTD), State (short term) disability – where applicable
• FSA (Flexible Spending Accounts) – Both Health Care & Dependent Care Available
• HSA (Health Savings Account)
• 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
• Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
• Critical Illness and Accidental Insurance
• Legal and Identity Theft Insurance
• Paid Time Off - Paid vacation, PTO, Holiday

Compensation

Min

USD $85,000.00/Yr.

Max

USD $90,000.00/Yr.

Physical Requirements

FIELD - While performing the duties of this job the employee is required to: Work in a temperature controlled office environment or travel via vehicle or commercial transportation While performing the duties of this job, the employee is occasionally required to handle or feel objects, talk, hear, and walk during the course of employment Position requires some degree of travel for business purposes Employee may use computer, phone, copier and other office equipment in the course of a day Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and an ability to adjust focus Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Additional Physical Requirements

Blood/Fluid Exposure Risk

Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.