Senior Specialist, Operations - API

Job Description

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.

At our site, you'll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

Job Purpose:

The API Operations Engineer supports the API Integrated Product Team (IPT) in the commissioning, qualification, start-up, and operational readiness of the new Small Molecule manufacturing facility in Elkton, Virginia. This role partners with cross-functional teams to help ensure safe, compliant, and efficient operations during project execution and through ongoing manufacturing. In addition, the API Operations Engineer helps coordinate and prioritize improvement activities and areas of focus across the IPT, supporting continuous improvement and operational excellence as the facility transitions into routine operations.

Primary Responsibilities:

• Support commissioning, qualification, start-up, and operational readiness activities for the new API 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.

• Help define, implement, and improve operating practices, standard work, procedures, and routines that support reliable and compliant operations.

• Coordinate and prioritize improvement activities and key areas of focus within the IPT in alignment with business objectives and operational performance goals.

• Use our company Production System (MPS) tools and lean principles, including Kaizen, 5S, visual management, and Standard Work, to identify and support improvement opportunities.

• Help embed best practices across shifts, functions, and work streams 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, supporting continuity of leadership and cross-functional coordination.

• Contribute to an inclusive, collaborative, and performance-driven work environment.

Minimum Required Education, Experience:

• Bachelor's degree in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Chemistry, or a related technical discipline.

• Minimum 5 years of experience in drug substance/API manufacturing, operations, technical operations, or a related manufacturing environment.

• 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.

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Required Skills:

Adaptability, Adaptability, Analytical Problem Solving, Biopharmaceutical Industry, cGMP Compliance, Data Analysis, Decision Making, GMP Compliance, Inventory Management, Lean Management, Lean Process Improvements, Lean…