Chemist B

Acrotech Biopharma Inc; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Aurolife seeks a Chemist B to conduct routine analytical testing and instrumentation in a GLP-compliant wet laboratory. You will handle sampling, data recording and ensure accuracy using HPLC, GC, UV-Vis and IR among other QC instruments to support product quality and regulatory standards.

You will plan testing workflows, prepare reagents, review procedures, calibrate instruments, and ensure compliance with cGMP/cGLP, contributing to a robust generic pharma portfolio.

Qualifications

• BS in a scientific field required, Chemistry preferred.
• 3-5 years in the pharmaceutical industry with 2-4 years in analytical testing.
• Experience in generic pharmaceuticals is a plus.
• Knowledge of Good Documentation Practices and USP/ICH/FDA guidelines.

Responsibilities

• Perform sampling, physical/chemical tests and assays on materials and products using wet chemistry and instrumental techniques.
• Plan reagents inventory and ensure supplies are available for testing.
• Execute testing to meet deadlines; document data and outcomes clearly.
• Prepare and review test procedures, SOPs and protocols.
• Calibrate and maintain laboratory instruments; troubleshoot under supervision.
• Comply with safety, cGMP, cGLP and regulatory requirements; appropriate documentation.

Skills

BS with Scientific field

Chemistry background

Pharmaceutical experience 3-5 years

Analytical testing 2-4 years

Generic pharma experience

GDP knowledge

USP/ICH/FDA knowledge

Fast learner

Education

BS in Science

Chemistry background

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 management team with expertise in manufacturing, R&D, Quality Assurance and Quality control 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 B Reposible for routina anlsyis for instrumentation as wwll as wet laboratory and mainatin the GLP in laboratory.

Responsibilities

• 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.
• Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
• Independently plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.
• Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.
• Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.
• Perform maintenance and calibrations of laboratory instruments/equipments with supervisory direction/training.
• Perform troubleshooting and investigations under the direction of a supervisor.
• 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.
• Review of Analytical documents as required

Qualifications - Skills & Requirements

• Minimum BS with Scientific field
• BS with Chemistry is one of the subjects would be preferable
• Minimum 3-5 years experience in pharmaceuticals and must have 2-4 year experience in Analytical testing
• Experience in Generic Pharmaceutical industries would be preferable
• Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
• Ability to learn quickly and decision making skills .

Education & Experience

Minimum BS with Scientific field
BS with Chemistry is one of the subjects would be preferable

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

No Additional Requirements

Blood/Fluid Exposure Risk

Category II: Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks.