Senior Specialist, Operations

About the role

The Senior Specialist, Operations will ensure operational excellence and continuous improvement within the shift manufacturing teams. Reporting directly to the Sr. Manager, Primary Manufacturing, you will provide technical and operational support; maintain a strong working knowledge of the manufacturing equipment set, control systems, and site operating systems.

Responsibilities

• Provide subject matter expertise on Primary Manufacturing including the filling and preparation functions to ensure success for all current and new products and processes.
• Serve as a key integrator for cross-functional teams supporting seamless operation of cGMP production, ensuring readiness of manufacturing areas for start-up, process qualification, and validation activities.
• Support the manufacturing operations team as a key contributor for projects that implement new technologies and operational process improvements in the GMP manufacturing environment, maintaining processing suites in a compliant and validated state.
• Lead or participate in continuous improvement projects, including capacity optimization and cost reduction programs.
• Support the development of the Operational Excellence programs and lead Manufacturing Projects with cross-functional stakeholders.
• Work with cross functional teams to review, author and revise standard operating procedures and batch records, review technical reports, assist with conducting deviation investigations, and write deviation reports.
• Document and communicate all aspects of work and learnings, providing training and mentorship for new personnel.
• Assist with metrics tracking and reporting to leadership teams.
• Support and participate in internal and external regulatory inspections as necessary.

Requirements

Education: Bachelor Degree in Engineering or Business. Prior experience with Project management or coordination required. Experience with aseptic fill/finish preferred. Prior production planning experience preferred.

Skills: 5 years related experience in lieu of a bachelor’s degree. Strong Analytical Skills and proficiency in data analysis tools and techniques required. Related Pharmaceutical experience preferred. Microsoft Office skills preferred.

Qualifications

Experience with aseptic fill/finish preferred. Prior production planning experience preferred. Strong Analytical Skills and proficiency in data analysis tools and techniques required. Related Pharmaceutical experience preferred. Microsoft Office skills preferred.

Benefits

Starting on your first day, you receive: Medical, Dental & Vision coverage, Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA), Life & AD&D Insurance, Short-Term & Long-Term Disability Insurance, Employee Assistance Program.

Pay

Hiring Wage: $81,800 – 130,900 annually, with opportunities for growth, promotion, and annual raises.

Schedule

On Site, Full-Time Monday- Friday 8:00-4:30pm; other work hours may be required.