Associate Director, Engineering

NCBioImpact; Durham (NC); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Job summary

NCBioImpact is seeking a Transformation and Business Support Lead for the Vaccine Manufacturing Facility in Durham, NC. You will spearhead a program of strategic projects aligned with facility transformation milestones while overseeing broad business support activities across Quality, Operations, Tech Ops, and Maintenance.

You will manage a team of engineers and scientists delivering change controls and other strategic initiatives, ensuring alignment with regulatory requirements and safety

Qualifications

• Bachelor Degree in Engineering, Science or related field.
• Minimum 8 years of experience with strong preference for Manufacturing Operations, Technical Operations, Quality Operations, or Site Engineering Services with supervisory responsibility.

Responsibilities

• Lead strategy development and independently manage project assignments.
• Manage a team of engineers and scientists supporting change controls and other initiatives.
• Unite Quality, Operations, Technology Operations, Maintenance, Digital Manufacturing and other functions behind a single execution plan.
• Provide end-to-end technical support through project lifecycle: quality risk management, SOPs, master batch records, process development and PPQ; review/approve documents.
• Lead cross-functional teams to address issues and achieve milestones.
• Support safety, environmental and compliance objectives.
• Escalate complex decisions to next level manager.
• Establish and lead a business support team to strengthen core operational processes like quality systems, change management, documentation, and operations effectiveness.

Skills

Cross-Functional Leadership

Technical Problem-Solving

Operations Management

Regulatory Inspections

Education

Bachelor Degree in Engineering, Science or related field

Job description

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

General Summary

The Vaccine Manufacturing Facility (VMF) is seeking a Transformation and Business Support Lead, who will lead an organization and portfolio of projects that will ensure the successful execution of strategic projects that are aligned with critical facility transformation milestones in addition to overseeing general business support activities.

General Profile

Responsibilities

• Reporting to the Director, Operations, the incumbent will assist in strategy development and will independently manage project assignments.
• Effectively manage a team of engineers and scientists supporting drug product facility change controls as well as other strategic initiatives, as requested

• Unite Quality, Operations, Technology Operations, Maintenance, Digital Manufacturing and other supporting functions behind a single integrated execution plan.

• Provide end-to-end technical support to assigned areas of focus throughout the project lifecycle including but not limited to quality risk management, strategy development, development of standard operating procedures and master batch records, process development, and process performance qualification. Review and approve project documents as necessary.
• Lead, facilitate and participate on cross-functional teams to collaboratively address issues and achieve project milestones.
• Supports team safety, environmental, and compliance objectives.
• Escalates and consults on an as-needed basis with next level manager on more complex decisions impacting critical project milestones.
• Establish and lead a business support team focused on strengthening core operational processes, including quality systems, change management, process optimization, documentation, and overall operations effectiveness.

People Management

The VMF Business Transformation & Support lead will directly oversee a team of project managers, ensuring their efforts are aligned to the department’s critical milestones and long-term objectives. This includes setting clear expectations, providing coaching and feedback, fostering collaboration across silos, and ensuring accountability to critical project milestones. The role requires developing talent, aligning individual goals to organizational priorities, and maintaining strong engagement and motivation during a period of intense transformation and delivery pressure.

QUALIFICATIONS

Required.

• Bachelor Degree in Engineering, Science or related field
• Minimum 8 years of experience with strong preference for individuals with two or more of the following experiences: Manufacturing Operations, Technical Operations, Quality Operations, or Site Engineering Services with supervisory responsibility with exempt personnel.

• Proven track record in pharma/biotech facility engineering/process changes controls & projects, with experience in driving strategic changes

Preferred

• Demonstrated ability to create an engaged workforce
• Demonstrated experience of interacting with regulatory agencies via on-site inspections
• Demonstrated successes with Talent Management, reorganization and strategic initiative

• Demonstrated program management, operational excellence, and cross-functional leadership.
• Comfortable influencing at all levels

• Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/Iean processing

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Required Skills

Cross-Functional Leadership, Driving Continuous Improvement, Engineering Principle, Facilities Construction, Facility Engineering, GMP Operations, Influencing Skills, Master Batch Records, Mentoring Staff, Operations Management, People Leadership, Regulatory Inspections, Talent Strategy, Technical Problem-Solving, Technical Transfer

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is:

USA - North Carolina - Durham (Old Oxford)

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/a