August Bioservices is seeking a highly organized, systems-oriented, and execution-focused leader to establish and lead the company’s continuous improvement program. This role will be responsible for identifying opportunities to progress both efficiency and compliance, ensuring cross-functional coordination, operational readiness, schedule adherence, and the execution discipline required to support a rapidly scaling sterile injectable manufacturing organization.
This leader will serve as the central integrator across Manufacturing, Quality, Supply Chain, Warehouse, Planning, Training, Technical Operations, and Maintenance to ensure activities required to execute manufacturing operations are proactively coordinated, visible, and completed on time.
This role will also oversee continuous improvement initiatives, such as 5S, Kaizen, Gemba, Lean Manufacturing, and Six Sigma.
This role will establish the operational management cadence, readiness governance, escalation processes, and performance visibility necessary to drive reliable execution and scalable operational performance across the organization.
This role is not responsible for directly managing manufacturing personnel. Instead, the role is accountable for driving continuous improvement, organizational readiness, execution coordination, dependency management, and operational accountability across functions. This position will report directly to the COO and will work closely with executive leadership across the organization.
Responsibilities
Establish and lead the company’s continuous improvement program and lead cross-functional continuous improvement initiatives
Develop and implement structured readiness reviews to ensure all prerequisites for successful execution are completed prior to the start of planned activity
Coordinate cross-functional activities required to support execution, including staffing, training, materials, documentation, equipment readiness, and quality support
Drive alignment between scheduling, staffing, material availability, and operational capabilities
Identify execution risks proactively and drive mitigation planning before operational impact occurs
Establish escalation mechanisms for readiness gaps, schedule risks, and execution barriers
Partner closely with Planning and Manufacturing leadership to improve schedule attainment and execution reliability
Ensure critical dependencies are identified, tracked, and completed on time
Implement structured tracking of execution delays, schedule misses, and recurring operational constraints
Lead recovery planning efforts when schedule disruptions occur
Drive accountability for execution commitments across functions
Design and implement standardized operational management cadences including but not limited to: daily execution review meetings, readiness review meetings, deliverable reconciliation processes, escalation reviews, recovery planning sessions.
Implement mechanisms for visibility into incomplete work, execution bottlenecks, and resource constraints
Partner with Quality and Manufacturing leadership to improve documentation completion timelines and investigation responsiveness
Implement performance tracking for: documentation completion cycle times, investigation aging, review timelines, recurring documentation errors, drive visibility and accountability around execution-impacting quality activities
Develop operational dashboards and management reporting focused on: Schedule adherence, readiness status, execution delays, staffing coverage, documentation timeliness, investigation performance, productivity metrics, bottleneck analysis
Establish objective operational visibility and escalation mechanisms for leadership review
Utilize data and trend analysis to identify recurring execution risks and improvement opportunities
Serve as a cross-functional leader capable of influencing without direct authority
Build strong working relationships across all operational and support functions
Drive a culture of accountability, proactive communication, operational discipline, and execution ownership
Support organizational scaling efforts through implementation of structured operational systems and management practices
Maintain a visible presence within operational areas to understand challenges and drive alignment
Continuous Improvement and Executional Readiness Leadership
Schedule Adherence & Dependency Management
Documentation & Investigation Performance
Performance Visibility & Metrics
Organizational Leadership
Qualifications
Bachelor’s degree in Engineering, Operations, Supply Chain, Basic Sciences, Business, or related field
8+ years of experience in complex operational environments with increased leadership responsibility
Demonstrated success leading cross-functional execution, coordination, and operational readiness initiatives through continuous improvement principles
Experience operating within highly regulated manufacturing environments
Strong experience implementing operational management systems, execution cadence, and accountability frameworks
Proven ability to manage complex dependencies and competing priorities across multiple functions
Experience utilizing metrics and operational data to drive performance improvements
Experience within sterile injectable pharmaceutical manufacturing, biologics, medical device, or other highly regulated industries
Experience in CDMO or high-complexity manufacturing environments
Experience supporting rapid organizational scaling and operational maturity initiatives
Familiarity with GMP documentation systems, training systems, deviation management, and manufacturing scheduling processes
Continuous Improvement training and experience
Exceptional organizational discipline and attention to detail
Strong systems thinking and operational problem-solving capabilities
Ability to drive accountability and follow-through across functions
Executive presence and composure under pressure
High sense of urgency balanced with sound judgment
Strong communication and escalation management skills
Comfort operating within ambiguity and rapidly changing environments
Ability to influence without relying on formal authority
Data-driven decision-making and operational rigor
Relentless focus on execution reliability and organizational alignment
Required Experience
Preferred Experience
Leadership Attributes:
Skills Required
- Bachelor's degree in Engineering, Operations, Supply Chain, Basic Sciences, Business, or related field
- 8+ years of experience in complex operational environments with increased leadership responsibility
- Demonstrated success leading cross-functional execution, coordination, and operational readiness initiatives through continuous improvement principles
- Experience operating within highly regulated manufacturing environments
- Strong experience implementing operational management systems, execution cadence, and accountability frameworks
- Proven ability to manage complex dependencies and competing priorities across multiple functions
- Experience utilizing metrics and operational data to drive performance improvements
- Experience within sterile injectable pharmaceutical manufacturing, biologics, medical device, or other highly regulated industries
- Experience in CDMO or high-complexity manufacturing environments
- Experience supporting rapid organizational scaling and operational maturity initiatives
- Familiarity with GMP documentation systems, training systems, deviation management, and manufacturing scheduling processes
- Continuous Improvement training and experience
What We Do
August Bioservices is a Contract Development and Manufacturing Organization (CDMO) headquartered in Nashville, Tennessee. August Bio offers a full range of pharmaceutical contract development and manufacturing services to pharmaceutical and biotech clients. We focus on sterile injectables, topicals, highly-complex formulations, poorly soluble & highly viscous compounds, Uncommon container sizes & fill volumes and offer aseptic and non-aseptic terminally sterilized filling of vials (liquid and lyophilized), syringes and flexible IV bags.
