Job Details

Tamarac, FL Full Time

Description

About Us:

Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Job Summary

Under the direct supervision of the Vice President of Technical Operations (US), the incumbent will lead the full operational activities of our Tamarac sterile manufacturing and packaging site. This role is crucial in ensuring safe work practices, manufacturing efficiency, regulatory compliance, and operational excellence, with a strong focus on aseptic processing and sterile products. The incumbent will drive day-to-day performance, develop systems to evaluate area performance, and contribute to continuous improvements in process reliability, quality, performance, and cost efficiencies. Additionally, this role will ensure alignment with strategic corporate objectives, fostering a culture of continuous improvement and high performance.

Key Responsibilities

Manages day to day operations by establishing site priorities and directing site activities to ensure quality products are formulated, developed, produced, and delivered to Aveva’s customers, in support of company goals and objectives. As the site expands, managing 2-3 Direct reports.
Align site operations strategy with broader business objectives, including demand forecasting, capacity expansion, and new product introductions.
Lead, mentor, and develop a high-performing technical operations team, driving a culture of ownership, accountability, collaboration, and innovation.
Foster a work environment where individuals and teams consistently take ownership of outcomes, enhancing trust, performance, and organizational success
Lead end-to-end production of sterile injectable products, including Blow-Fill-Seal (BFS), vials, syringes, cartridges, and other delivery formats.
Optimize key manufacturing operations (compounding, aseptic filling, inspection, packaging) to improve efficiency, reduce cycle times, enhance yields, and minimize waste.
Prepares and administers department budget to achieve the site plan, maintaining cost consciousness and stressing operational efficiencies throughout.
Ensure strict compliance with cGMPs, FDA regulations, and other applicable global standards for aseptic manufacturing
Strengthen contamination control strategies, including gowning practices, cleanroom behaviors, and environmental monitoring systems; plays an active role on quality management teams within the organization.
Ensures compliance with all safety rules and regulations and creates, monitors, and maintains a safe work environment.
Develops, nurtures, and trains staff to further departmental and organizational goals.
Provides project management support for new and existing internal products as well as client’s products.
Ensures project deadlines and performance standards are established and met.
Provides technical support and problem solving for new products under development as well as existing commercial products.
Develops organizational objectives to meet organization’s needs.
Ensures that accurate and up to date SOP’s are in place and that all departments are in compliance with current procedures and practices.
Sponsors and facilitates the use of systems and metrics to guide the initiation and execution of safety, quality, productivity and continuous improvement initiatives in support of the Operations Strategic Plan and Production Plan.
Establish and monitor operational KPIs including Batch Yield and Scrap Rates, Throughput and Cycle Times, First Pass Quality and Deviation Metrics, Machine Downtime and OEE, On-Time Delivery and Supply Plan Adherence
Analyze performance trends and develop data-driven action plans to address underperformance and drive operational excellence.
Ensures team is professional and performs all work in accordance with established regulatory, compliance and safety requirements. Reviews and approves investigations and ensures systemic preventive/corrective action for all safety and compliance non-conformances are implemented.
Develop and support a culture within the organization that promotes troubleshooting and problem solving at the team level

Recruits, trains, develops and manages effectively the ongoing performance of their direct reports, which includes, but is not limited to:

Ensuring all Job Descriptions for direct reports are periodically reviewed, signed and stored according to our job description processes;
Reviewing and updating development plans for all direct reports, ensuring that all direct reports are properly trained and qualified according to our Training and Employee Qualification Enterprise Policy;
Effectively managing performance for direct reports according to the Performance Management Program,
Attracting and retaining talent based on our talent management framework;
Scheduling regular one-on-one meetings, probationary performance reviews and mid-year performance discussions;
Providing regular coaching, feedback and recognition based on the expected behaviors, job description and performance on objectives; and
Responsible to ensure compliance of team members (direct reports) with the Business Ethics and Compliance Program, Quality procedures, Safety and Environment policies, and HR policies.
Works as a member of a team to achieve all outcomes;
Leads with a mindset that respects all cultural dimensions;
Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion
All other duties as assigned.

Qualifications

Education:

Bachelor’s Degree in Engineering, Life Sciences, Pharmacy, or a related technical field required.
Master’s degree from an accredited college or university in Pharmacy, Engineering or Business Administration (MBA), or 5-7 years in a senior managerial role overseeing multiple departments (such as production, supply chain and maintenance)

Knowledge, Skills And Abilities

Self-starter and a team player who will thrive in an entrepreneurial and matrixed environment
Solid experience in management operations, business principles and practices
Demonstrated leadership experience particularly in the areas of approachability, dealing with direct reports, managing diversity, setting goals and objectives and measuring performance
Computer literacy with Microsoft Office programs and exposure to SAP or other ERPs
Proven experience in systematic problem solving
Strong leadership, communication, decision-making, and organizational skills Excellent interpersonal skills; strong ability to influence and build consensus among diverse stakeholders
Ability to thrive in a fast-paced, results oriented environment
cGMP, FDA, DEA, and other regulatory requirements in sterile pharmaceutical manufacturing
Functionally capable of analyzing and troubleshooting problems, identifying solutions, and recommending and implementing methods or techniques for resolution.

Experience

15 – 20 years of management level pharmaceutical manufacturing experience. An equivalent combination of education and experience may be substituted.

Benefits

Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan

Medical/Dental/Vision Insurance
Paid Time Off
401k with employer match
Paid Holidays and Floating Holiday

Equal Opportunity Employer

Aveva Drug Delivery Systems

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