Scientist, Formulations

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!

August Bioservices is seeking a Scientist / Sr Scientist, Formulations. Reporting to the Director, Formulations, the Formulation Scientist will be responsible for leading the formulation development, scale-up and tech transfer activities to support drug product development program for various chemical entities. This ideal candidate should possess exceptional time management and communications skills with a strong attention to detail. An extensive understanding of analytical analyses and characterization for formulation design, process development and scale-up approaches is required

Responsibilities

• Responsible for performing formulation development activities for parenteral formulations for small molecules including peptides in vials, IV bag premixes, and Prefilled syringes.
• Experience in developing formulations for poorly soluble drug substances.
• Develops solutions, emulsions, suspensions, lyophilized sterile parenterals and lipid-based delivery systems.
• Conduct phase specific studies based on DOE (Design of Experiments), as needed, for formulation optimization and process confirmation.
• Prepare and review documents to support specific project needs, such as laboratory notebooks, protocols, summary reports, regulatory submissions, master batch records, change control, etc.
• Prepare data summary presentations, compile experimental and analytical results and observations, perform data interpretation, and summarize conclusions and recommend subsequent steps.
• Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Develop formulation / manufacturing process from tech transfer to operations in support of GMP manufacturing.
• Incorporate Quality-by-Design (QbD) approach in the product development program to improve the drug formulation and manufacturing process.
• Collaborate with other teams (Project Management, Analytical Scientists, Quality Assurance and Manufacturing) to ensure project completion.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Takes lead in client interactions.

Requirements

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.

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