Sr Manager Engineering- Process Development

Senior Manager Engineering

Role Overview: The Senior Manager Engineering will develop and implement technical solutions for various engineering initiatives related to the FDP product portfolio at the Ohio manufacturing site. This key role in the Process Development group requires extensive technical expertise to coordinate multiple sophisticated, non-routine projects involving planning, design, reconfiguration, construction, maintenance, validation, and alteration of systems, facilities, and processes. The role also demands the application of advanced and diverse engineering principles across multiple areas, including process, unit operations, equipment, devices, and materials, in complex process characterization, validation, optimization, scale-up, or manufacturing support projects.

Project Management:

• Lead the New Product Introduction (NPI) process.
• Oversee Equipment Characterization and Validation for all GMP equipment and processes at the Ohio site.
• Provide technical operations support for continuous improvement of packaging lines capacity and performance.
• Advise on technical improvement projects.
• Ensure effective communication with all partners across the commercial site network and deliver on technical improvements.

Technical Lead:

• Act as the site technical expert for FDP combination and non-combination products.
• Serve as the technical expert for new process equipment and technology.
• Utilize technical process knowledge to identify and resolve process challenges.
• Lead the Commissioning, Qualification, and Validation of all process and GMP equipment at the Ohio site.
• Maintain and execute the site master validation plan for GMP equipment.

Operational Excellence:

• Support productivity, throughput, and general capacity improvements across the Ohio site.
• Analyze, design, and implement manufacturing and business process improvements.

Relationships:

• Build a network of FDP expertise across commercial and clinical operations for product assembly, labeling, and packaging.
• Leverage this network to support GMP technical expertise, performance trending, equipment standardization, and troubleshooting/process improvements at the Ohio site.

Qualifications:

Basic Qualifications:

• Doctorate degree & 2 years of Engineering experience
• OR Master's degree & 6 years of Engineering experience
• OR Bachelor's degree & 8 years of Engineering experience
• OR Associate's degree & 10 years of Engineering experience
• OR High school diploma / GED & 12 years of Engineering experience

In addition to meeting at least one of the above requirements, candidates must have a minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Managerial experience may run concurrently with the required technical experience.

Preferred Qualifications:

• Excellent written and verbal communication skills.
• Ability to work effectively in a team environment.
• Proven track record of leading and driving multi-functional projects.
• Strong teamwork, interpersonal, and communication skills.
• Direct experience with the manufacturing process for devices, combination products, and labeling & packaging operations.
• Experience working with Final Drug Product equipment suppliers.
• Ability to work in a highly regulated and ever-changing industry.
• Ability to learn and rapidly adapt to new requirements in a fast-moving environment.
• Operational Excellence approach to work product - driving rapid results.
• Passion for delivering excellent work and developing others with a positive attitude.

What You Can Expect: We are committed to supporting your professional and personal growth and well-being. From competitive benefits to a collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including relevant skills, experience, and qualifications.

In addition to the base salary, we offer a Total Rewards Plan, based on eligibility, comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.