Senior Operations Specialist

About the role

We aspire to be the premier research‑intensive biopharmaceutical company, using leading‑edge science to save and improve lives worldwide. Our purpose‑built, agile small‑molecule manufacturing site in Elkton, Virginia moves quickly and reliably, receiving technology transfers from commercialization sites and fast‑following into production with a focus on quality, safety, and operational excellence. The site is committed to a safe, environmentally responsible, and compliant workplace where people can do their best work. This position reports to the Production Lead, DP&SDI and supports the DP and SDI Integrated Product Team (IPT) in commissioning, qualification, start‑up, and operational readiness of the new facility, partnering with cross‑functional teams to ensure safe, compliant, and efficient operations and to drive continuous improvement as the plant transitions to routine production.

Responsibilities

• Support commissioning, qualification, start‑up, and operational readiness activities for the new SDI Small Molecule facility in Elkton, VA.
• Partner with Operations, Engineering, Quality, Technical Operations, Supply Chain, and other stakeholders to support safe, compliant, and effective plant start‑up.
• Provide technical and operational support during equipment and process start‑up, troubleshooting, and optimization activities.
• Support technology transfer and implementation of commercial manufacturing processes into the new facility.
• Define, implement, and improve operating practices, standard work, procedures, and routines that support reliable and compliant operations.
• Coordinate and prioritize improvement activities and key focus areas within the IPT in alignment with business objectives and performance goals.
• Use the company Production System (MPS) tools and lean principles—including Kaizen, 5S, visual management, and Standard Work—to identify and support improvement opportunities.
• Embed best practices across shifts, functions, and workstreams to promote consistency, efficiency, and strong operational execution.
• Support a culture of safety, quality, compliance, accountability, and continuous improvement.
• Act as a delegate for the Production Lead when needed, ensuring continuity of leadership and cross‑functional coordination.
• Contribute to an inclusive, collaborative, and performance‑driven work environment.

Minimum Requirements

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Chemistry, or a related technical discipline (engineering degree not required).
• Minimum 5 years of experience in Drug Product/SDI manufacturing, operations, technical operations, or related manufacturing experience in spray drying.
• Experience working in a cross‑functional manufacturing, technical, or operational setting.
• Experience contributing to operational improvement, troubleshooting, process support, or start‑up‑related activities.
• Working knowledge of GMP, quality, and compliance expectations in pharmaceutical manufacturing.
• Strong problem‑solving, communication, collaboration, and organizational skills.
• Ability to work effectively across Operations, Engineering, Quality, and Technical teams.
• Ability to prioritize work in a dynamic, fast‑paced environment.
• Demonstrated commitment to safety, operational excellence, and continuous improvement.

Preferred Qualifications

• Experience supporting commissioning, qualification, start‑up, or validation activities.
• Experience in a greenfield or new facility start‑up environment.
• Experience with technology transfer and implementation of commercial manufacturing processes.
• Experience applying lean tools and methodologies, including Kaizen, 5S, and Standard Work.
• Experience coordinating activities across shifts, teams, or functions.
• Experience serving in a lead, coordinator, or delegate role supporting leadership continuity.
• Experience identifying improvement opportunities and helping implement practical solutions in a manufacturing environment.

Required Skills

• Adaptability
• Analytical Problem Solving
• Biopharmaceutical Industry knowledge
• cGMP Compliance
• Data Analysis
• Decision Making
• GMP Compliance
• Inventory Management
• Lean Management
• Lean Process Improvements
• Lean Six Sigma Continuous Improvement
• Manufacturing Environments
• Manufacturing Operations
• Manufacturing Technologies
• Operational Excellence
• Personal Initiative
• Pharmaceutical Manufacturing
• Pharmaceutical Process Engineering
• Process Improvements
• Process Optimization
• Production Planning
• Production Scheduling
• Technical Acumen
• Technology Transfer
• {+ 2 more}