What are the responsibilities and job description for the Director, Operations position at Phlow?
Apply
Description
The Director, Operations serves as a senior operational leader and strategic partner to the VP, Site Lead, helping lead and scale pharmaceutical manufacturing operations across the Petersburg site. This role functions as the operational second-in-command for the site and provides leadership across manufacturing execution, operational strategy, engineering coordination, organizational performance, compliance, and continuous improvement initiatives.
The Director, Operations is responsible for translating business strategy into operational execution while ensuring the site operates safely, compliantly, efficiently, and at scale. This individual will drive cross-functional alignment across Operations, Engineering, Quality, Supply Chain, Maintenance, EHS, and other site functions to support business growth, manufacturing readiness, operational excellence, and long-term site expansion.
The ideal candidate is an experienced pharmaceutical manufacturing leader with demonstrated success leading complex regulated operations, building high-performing organizations, and driving operational transformation in fast-paced environments.
Requirements
Site Leadership & Strategic Partnership
Description
The Director, Operations serves as a senior operational leader and strategic partner to the VP, Site Lead, helping lead and scale pharmaceutical manufacturing operations across the Petersburg site. This role functions as the operational second-in-command for the site and provides leadership across manufacturing execution, operational strategy, engineering coordination, organizational performance, compliance, and continuous improvement initiatives.
The Director, Operations is responsible for translating business strategy into operational execution while ensuring the site operates safely, compliantly, efficiently, and at scale. This individual will drive cross-functional alignment across Operations, Engineering, Quality, Supply Chain, Maintenance, EHS, and other site functions to support business growth, manufacturing readiness, operational excellence, and long-term site expansion.
The ideal candidate is an experienced pharmaceutical manufacturing leader with demonstrated success leading complex regulated operations, building high-performing organizations, and driving operational transformation in fast-paced environments.
Requirements
Site Leadership & Strategic Partnership
- Serve as a key member of site leadership and trusted advisor to the VP, Site Lead on operational strategy, business planning, and organizational priorities.
- Provide leadership and direction across manufacturing operations to ensure alignment with company objectives, customer commitments, and growth initiatives.
- Act on behalf of the VP, Site Lead as needed in operational decision-making, issue escalation, and cross-functional leadership activities.
- Lead execution of site-wide strategic initiatives, operational readiness programs, and business transformation efforts.
- Drive organizational alignment across Operations, Engineering, Quality, Supply Chain, Maintenance, EHS, and supporting functions.
- Support long-range planning for manufacturing capacity, operational scalability, capital investments, and workforce growth.
- Establish operational governance, accountability systems, and performance management processes across the site.
- Direct day-to-day manufacturing operations to ensure safe, compliant, reliable, and efficient production performance.
- Drive operational excellence across production, scheduling, staffing, throughput, quality, productivity, and cost performance metrics.
- Ensure manufacturing operations comply with all applicable FDA, cGMP, DEA, EPA, OSHA, and ICH Q7 regulatory requirements.
- Develop and implement strategies to improve operational efficiency, manufacturing reliability, capacity utilization, and schedule attainment.
- Lead Lean Manufacturing, Six Sigma, and continuous improvement initiatives across the organization.
- Partner with Engineering and Maintenance to improve equipment reliability, process robustness, and plant scalability.
- Support technology transfer, process scale-up, process optimization, and commercial manufacturing readiness initiatives.
- Champion operational discipline, visual management, tiered accountability, and data-driven decision making throughout the organization.
- Foster a culture of quality, safety, compliance, accountability, and operational excellence across the site.
- Partner closely with Quality Assurance to ensure strong inspection readiness and sustainable compliance performance.
- Provide leadership support for deviations, investigations, CAPAs, change controls, and audit responses.
- Lead root cause analysis and corrective action efforts related to operational, quality, or safety events.
- Ensure operational risks are proactively identified, mitigated, and escalated appropriately.
- Support development and continuous improvement of site quality systems, operational procedures, and compliance programs.
- Build, lead, and develop high-performing operational teams and leadership talent across the organization.
- Provide coaching and mentorship to managers and functional leaders to strengthen organizational capability and succession readiness.
- Create a culture centered on accountability, collaboration, engagement, continuous improvement, and execution excellence.
- Lead workforce planning, organizational scaling, succession planning, and talent development initiatives to support site growth.
- Establish strong communication rhythms through operational reviews, leadership meetings, KPI reporting, and tiered escalation processes.
- Drive employee engagement and leadership visibility throughout manufacturing operations.
- Lead operational planning and execution to achieve site financial objectives and operational performance targets.
- Partner with Finance and Supply Chain on budgeting, forecasting, inventory strategy, standard costs, variance management, and capital planning.
- Support development of CAPEX strategies, manufacturing investments, and operational prioritization initiatives.
- Monitor and improve cost performance through operational efficiency, productivity improvements, and resource optimization.
- Prepare and present operational updates, strategic recommendations, business risks, and performance metrics to executive leadership.
- Bachelor’s degree in Engineering, Chemistry, Pharmaceutical Sciences, or related technical discipline required; advanced degree preferred.
- 12 years of progressive pharmaceutical manufacturing experience, including senior leadership responsibility within regulated operations.
- Strong preference for API manufacturing experience.
- Experience supporting both small kilo-scale and large-scale metric ton manufacturing operations.
- Experience with process scale-up and design for manufacturability.
- Batch processing experience and familiarity with flow chemistry operations.
- Understanding of potent compounds, containment strategies, and OEB/OEL requirements.
- Demonstrated success leading complex manufacturing organizations and cross-functional teams within cGMP environments.
- Deep understanding of FDA, cGMP, ICH Q7, environmental, health, and safety regulatory requirements.
- Experience supporting site expansion, operational scaling, capital projects, technology transfers, or major operational transformation initiatives.
- Proven ability to lead organizational change and drive operational excellence initiatives.
- Strong executive presence with the ability to influence across all levels of the organization.
- Demonstrated experience implementing Lean Manufacturing, Six Sigma, or operational excellence methodologies.
- Strong financial acumen, analytical capabilities, and strategic decision-making skills.
- Excellent communication, organizational, and leadership skills.
- Exceptional oral and written communication skills, including regulatory technical writing skills.
- Ability to work in a cross-functional team environment with dynamic timelines and priorities
- Exhibits the highest level of reasoned judgment, discretion, and integrity. Integrity is our defining characteristic at Phlow
- Collaborates with others to achieve shared objectives. At Phlow, we are focused on working together, accepting feedback, and making it about results
- Ability to thrive in a fast-moving, continuous learning environment; iterating and learning as a team
- Active listener with a curious and open mind
- Steadfastly pursues excellence in execution
- Servant leader
- Self-starter
- Ability to deal with ambiguity
- Constantly required to see & utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
- Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
- Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
- This will be both a manufacturing and office role.
- Occasionally lift and/or move up to 10 pounds.