Quality Control Lead

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

Quality Control Lead operates independently to perform chemical analyses of raw materials and finished products under cGMP Guidelines. The Lead supports all the chemists in the laboratory through training, expertise in USP\EP monograph testing, and understanding the instrumentation for raw material and finished good testing. The Lead will maintain a working knowledge of all USP/EP monograph testing and author in writing test methods, specifications and certificates of analysis. The lead will lead investigations and train other laboratory personnel on all testing (both routine and non-routine). The lead will also be able to perform method verifications and method transfers as necessary. The lead is a resource for all laboratory operations, equipment qualification requirements, best practices in chromatography method execution, and quantitative analysis in non-chromatography methods.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Subject matter expert in wide range of analytical procedures in the laboratory, including wet chemical analyses and instrument-based methods.
• Capable of being a subject matter expert in the laboratory to foster communication and training of chemists at all levels of the organization
• Maintain a safe, clean and organized work area.
• Support lab waste management, including correctly labeling and storing reagents.
• Performs laboratory testing on raw materials and finished products (including in-process and stability samples).
• Prepare test solutions, compounds or reagents for analysis of raw materials and finished products.
• Accurately and precisely perform various wet chemistry techniques.
• Perform assay, impurity/degradant and solvent determinations by chromatographic analysis via thin-layer, gas (GC), high performance (HPLC), Mass Spectroscopy, and ultra performance chromatography (UPLC).
• Perform major maintenance and troubleshooting on all analytical equipment.
• Work in cross functional teams as necessary to complete projects, transfers, and investigations
• Perform daily calibrations and necessary preventative maintenance on specified analytical equipment.
• Multitask projects while maintaining efficient and accurate laboratory practices.
• Accurately documents all necessary and relevant information in a clear and concise manner per cGMP requirements.
• Ability to create and execute both method protocols and reports.

QUALIFICATIONS

• Bachelor’s degree in chemistry, biology, or related science and 7+ years of pharmaceutical experience or equivalent or master’s degree in chemistry, biology or related science and 3+ years of pharmaceutical experience.

KNOWLEDGE, SKILLS, & ABILITIES

• Perform laboratory testing and duties for stability samples, formulation samples, in-process samples and raw material samples.
• Identify as a laboratory subject matter expert for pharmaceutical manufacturing. Understanding of validation and verification requirements for raw materials and finished goods
• Ability to effectively train other analysts on various wet chemical testing and specified instrumentation.
• Complete complex laboratory investigations with a thorough understanding of root cause analysis and required CAPAs. Be able to fully complete NCRs and assign associated risk levels.
• Accurately documents all necessary and relevant information in a concise manner per cGMP requirements.
• Identify as an expert on LC and GC equipment
• Ability to train other analysts on all USP/EP monograph testing, as well as lead designated group training associated with OOS/CAPAs.
• Complete department trend reviews and analyses
• Support any sample submissions and appropriate testing.
• Working knowledge of current regulatory guidelines.
• Cross-functional workability with direct and indirect coworkers.
• Maintain current training in the Quality Management System with no overdue tasks.
• Always operate under safety requirements, including use of PPE and adherence to company policies in handling hazardous substances.
• Efficient in Microsoft Office Products,
• Efficient in modern LC software systems
• Utilize root cause analysis techniques to solve complex laboratory investigations
• Capable to present to senior leadership key performance indicators or project work related to compliance or cost saving improvements
• Management representative when in the lab and verifying GMP compliance

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.