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Form of workHeadquartered 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 Quality Control Manager, Microbiology reports to the Director of Quality Control. They will provide leadership to the microbiology laboratory through all phases of development. They will be responsible for managing the microbiological evaluation of raw materials, components, drug product intermediate, finished drug product and stability samples. They will also be responsible for the managing the environmental monitoring and aseptic process simulation programs. 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 microbiological testing activities for several of the following functions but not limited to: raw material, component, drug product, stability, validation, investigational, in-process testing, etc.
- Oversee environmental monitoring, aseptic process simulation and gowning qualification programs.
- Serve as a subject matter expert for microbiology
- Lead, guide, and mentor analysts
- Foster a culture of continuous improvement
- Ensure the laboratories are clean, organized, compliant, and audit ready at all times.
- Support formulation, process development, and scale-up activities
- Review and approve laboratory data for accuracy and completeness
- Lead and serve on cross-functional project teams
- 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
- Prepare annual laboratory budgeting
- Perform annual performance assessments of direct reports
- Bachelor's Degree in biology, or related science and 8-10 years of experience in a pharmaceutical laboratory management role.
- Must possess strong knowledge of SOPs, laboratory procedures, FDA and ICH guidance, USP regulations, microbiological testing techniques, and cGMP.
- Strong track record of leadership skills and influence
- Strong interpersonal skills. Ability to build effective and constructive relationships.
- Ability to work cross-functionally both internally and externally
- Must be a leader, mentor, and self-motivated to develop a high performing team
- Must possess excellent written and verbal communication skills, interpersonal skills, management skills, strong work ethic, and organizational skills
- Demonstrated analytical and problem-solving 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.
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