Analytical Chemistry Supervisor- 2nd Shift
Nashville, Tennessee
Quality – Quality Control /
Full-Time /
On-site
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!
The Analytical Chemistry Supervisor reports to the Analytical Chemistry Manager. They will provide leadership to the QC laboratory during 2nd shift to support testing be done for work for all phases of development. They will be responsible for managing in-process, release and stability testing for finished drug products. They will be required to work in development and regulated environments, including adherence to cGMPs, regional and country specific regulations, as well as internal SOPs.
Responsibilities
- Oversee analysis of in-process, finished good and stability samples.
- Serve as the subject matter expert for specification development for release and stability testing of finished goods.
- Coordinate the routine analysis of finished goods for Subvisible Particulate, HPLC/UPLC, Container Content, Container Closure Integrity, Water Content, pH, Osmolality, Viscosity, Appearance, UV-Vis. etc.
- Administer stability testing program compliant with ICH Guidelines.
- Lead, guide, and mentor a Team of Analysts.
- Foster a culture of continuous improvement.
- Ensure the laboratories are clean, organized, compliant, and audit ready at all times.
- Review and approve analytical data for accuracy and completeness.
- Prepare protocols, technical reports, and other documentation for CMC related activities.
- Identify and resolve project-related issues that have the potential to impact project deliverables.
- Ensure compliance of laboratory personnel and equipment.
- Perform annual performance assessments of direct reports.
Requirements
- Bachelor’s Degree in chemistry, biology, or related science and1-3years of experience in a pharmaceutical laboratory management role focused on analytical chemistry.
- Must possess strong knowledge of SOPs, laboratory procedures, FDA and ICH guidance, USP regulations, analytical testing techniques, and cGMP.
- Strong track record of leadership skills and influence
- Strong interpersonal skills. Ability to build effective and constructive relationships.
- Must possess excellent written and verbal communications kills, interpersonal skills, management skills, strong work ethic, and organizational skills
- Ability to work with minimal supervision
- Proficient in Microsoft Word, Excel, Outlook, and PowerPoint
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.
