Manufacturing Lead Technician - 2nd Shift

august bio; Nashville (TN); On-site; USD 45,000 - 75,000; Full time

Job summary

An established industry player seeks a Manufacturing Lead Technician to join their dynamic team in Nashville. This role involves ensuring compliance with Good Manufacturing Practices (GMP) while mentoring fellow technicians in a cleanroom environment. As part of a high-growth organization, you will be instrumental in supporting the production of life-changing therapies. The company values innovation and collaboration, offering a unique opportunity to make a significant impact in global health. If you're ready to take on a rewarding challenge and grow your career, this position is perfect for you.

Qualifications

• Experience in pharmaceutical manufacturing required.
• Mechanical aptitude to troubleshoot equipment is essential.

Responsibilities

• Ensure compliance with GMP in a cleanroom environment.
• Mentor and train team members on production activities.
• Lead process improvement initiatives for production.

Skills

Attention to detail

Effective communication

Mechanical aptitude

Mathematical skills

Leadership and coaching

Education

High School Diploma

Associate degree in technical field

Bachelor's degree in biological, chemical sciences, or engineering

Tools

Sterilization equipment

Production equipment

Documentation software

Job description

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 Manufacturing Lead Technician is responsible for ensuring all team members on the floor, including themselves, are able to operate and maintain processing equipment, prepare components for aseptic and non-aseptic operations, and ensure compliance with Good Manufacturing Principles (GMP) in a cleanroom environment. The Manufacturing Lead Technician is responsible for mentoring other Technicians on the team, and assigning work or overseeing floor activities in the absence or in addition to the Manufacturing Supervisors.

Responsibilities

• Perform routine cleaning and sanitization of production areas to maintain a controlled and compliant environment.
• Prepare and transfer materials and components for production using proper sanitization techniques and aseptic handling practices.
• Perform inspection, labeling, and packaging of vials, IV bags, and syringes.
• Load, operate, and unload sterilization equipment, such as autoclaves, terminal sterilizer, and HEPA transfer carts.
• Operate and maintain equipment used across all production processes, including formulation, filling, sterilization, inspection, and packaging with support and oversight from other Manufacturing team members.
• Perform dispensing and formulating raw materials for aqueous and non-aqueous products, ensuring accuracy and compliance with batch records.
• Perform setup and operation of filling lines and associated equipment, including mixers, tanks, pumps, autoclaves, and HEPA transfer carts.
• Perform preparation of equipment for use using sterilization equipment such as autoclaves and HEPA cabinets.
• Utilize proper aseptic techniques in Grade B/C/D and CNC environments during all tasks.
• Become proficient and achieve Qualified Trainer status for manufacturing activities across all key functions of the manufacturing team, including sanitization, equipment preparation, packaging and labeling, formulation, and filling.
• Consistently train new team members on activities as assigned by Manufacturing leadership and the Training department and look for opportunities to support all Manufacturing team members in training.
• Take a proactive approach to suggesting and implementing solutions that support maintaining a safe work environment.
• Ensure Good Documentation Principles (GDP) are adhered to across the Manufacturing department.
• Consistently offer constructive feedback and coaching to other team members.
• Support Manufacturing leadership in building schedules, assigning tasks, and overseeing work on the floor.
• Step in on days Supervisors may be unavailable to manage production work.
• Regularly collaborate cross-functionally with Quality Assurance, Quality Control, Engineering, Validation, and Maintenance teams as needed to support the timely execution of production activities.
• Regularly lead process improvement initiatives in support of production activities.
• Serve as a point of escalation for on-the-floor production.

Qualifications

• High School Diploma or equivalent required. An associate degree in a technical field or a bachelor's degree in biological, chemical sciences, or engineering preferred but not required.
• Experience in the pharmaceutical manufacturing industry in a production role.
• Mechanical aptitude to operate and troubleshoot a variety of equipment and instruments.

Knowledge, Skills, & Abilities

• High level of understanding of both GMP and GDP standards.
• Strong attention to detail, with the ability to follow SOPs, complete documentation tasks accurately.
• Experience leading, coaching, or training others in a pharmaceutical manufacturing environment.
• Basic computer skills and familiarity with technical documentation.
• Mathematical skills for measurements and calculations (e.g., volume, weight).
• Physical ability to raise arms over head, stoop, stand, climb, and lift 30-50 lbs.
• Effective verbal and written communication skills.

Physical Requirements

• Prolonged periods of standing, walking, or working in a cleanroom environment.
• Ability to wear fully protective gowning for extended periods.
• Must be able to lift and transport materials weighing up to 50 lbs.

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 everyday 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.