Chemist B

Acrotech Biopharma Inc; Durham (NC); On-site; USD 65,000 - 75,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision plan

401(k) plan

EAP

Paid time off

Job summary

Aurolife in Durham is seeking a Chemist B to ensure that materials and products meet established quality standards and regulatory requirements through laboratory tests and documentation.

The role requires 3–5 years in pharmaceuticals with analytical testing experience, GMP knowledge, and meticulous attention to detail. Competitive salary and comprehensive benefits are offered.

Qualifications

• Minimum 3–5 years experience in pharmaceuticals and 2–4 years in analytical testing.
• Experience in generic pharmaceutical industries preferable.
• Knowledge of Good Documentation practices.
• Knowledge of USP/ICH/FDA regulations.
• Ability to learn quickly and exercise good decision making.

Responsibilities

• Perform physical, chemical and instrumental tests on raw materials, in-process, finished and stability products using USP monographs and in-house procedures.
• Plan and maintain inventory of reagents and solutions for testing.
• Execute testing to meet established timelines with supervision as needed.
• Document data and results clearly and accurately.
• Prepare and/or review test procedures, SOPs, and protocols.
• Maintain and calibrate laboratory instruments with supervision.
• Troubleshoot and investigate under supervision.
• Ensure compliance with cGMP, cGLP and safety regulations.

Skills

Analytical testing experience

GxP knowledge

Regulatory knowledge

Good Documentation practices

Pharmaceutical industry experience

HPLC/GC/UV-Vis/IR

Instrument maintenance

Education

BS in a scientific field

BS in Chemistry preferred

Tools

HPLC

GC

UV-Vis

IR

Particle Size Analyzer

KF Auto titrator

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 is responsible for ensuring that products and materials meet established quality standards and regulatory requirements by conducting laboratory tests, analyzing results, and maintaining accurate documentation. They perform testing on raw materials, in-process samples, and finished goods using various analytical techniques, while adhering to standard operating procedures (SOPs), standard test procedures and Good Manufacturing Practices (GMP). QC Analysts also investigate discrepancies such as out-of-specification results, support corrective actions, maintain laboratory equipment, and ensure compliance with regulatory guidelines. This role requires strong attention to detail, technical expertise, and the ability to work in regulated environments.

Responsibilities

• Perform physical, chemical and instrumental tests 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 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, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
• Review of analytical documents as required.

Qualifications - Skills & Requirements

• 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 preferred.
• 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.

Notice To Recruitment Agencies

Please note that we are not accepting unsolicited resumes or proposals from recruitment firms or agencies for this position. Thank you for your understanding.

Compensation

Min: USD $65,000.00/Yr.

Max: USD $75,000.00/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.
• 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 III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.