Director, Engineering - Drug Product Commercialization

Job Description

Job Description: Director, Center of Excellence for Sterile Drug Product Commercialization

Overview

We are seeking a dynamic and experienced leader for the role of Director within our Center of Excellence (CoE) for Sterile Drug Product Commercialization.  Sterile Drug Product Commercialization is the Company's Manufacturing Division business unit responsible for late-stage development of vaccines, biologics and sterile pharmaceutical drug products.  Sterile Drug Product Commercialization also provides drug product process development and process characterization laboratory services for inline products.

This position will be pivotal in overseeing core drug product technologies, building our pipeline platforms and standard work systems, establishing innovative solutions for our sterile processes and providing oversight to our inline product support laboratory. The CoE will drive innovation and operational excellence in the development and commercialization of sterile drug products through the use of core and innovative technologies.

About Us

Our company, a global biopharmaceutical leader, operates in the United States, Canada, Puerto Rico, and across Europe, the Middle East, Africa, Latin America, and Asia Pacific. With a diverse portfolio that includes prescription medicines, oncology, vaccines, and animal health products, we are committed to developing and delivering innovative solutions that save and improve lives. Our workforce of 69,000 employees in over 140 countries is dedicated to research and development, with a proud history of 125 years of service to humanity.

Key Responsibilities

As the Director of the Center of Excellence, you will:

• Lead Technical Excellence: Oversee the design, development, and commercialization of sterile liquid and lyophilized drug products, ensuring robust validation and technology transfer processes.
• Team Management: Manage a team of scientists and engineers, fostering talent development, mentorship, and strategic guidance to enhance technical capabilities.
• Project Oversight: Ensure that commercialization programs meet scientific, quality, reliability, schedule, and cost requirements. Monitor performance and recommend adjustments as necessary.
• Process Optimization: Drive continuous improvement initiatives and implement standardized platforms for liquid, lyophilized, and combination product presentations.
• Innovation and Collaboration: Actively seek cutting-edge technologies in manufacturing and testing, and develop collaborations with internal and external partners.
• Resource Management: Optimize resource allocation across projects to achieve business objectives and support due diligence and business development opportunities.
• Culture Building: Establish a high-performance culture that promotes innovation, diversity, and inclusion within the team.

Qualifications

Education

• Doctorate in Applied Sciences, Engineering, or a related discipline with 6+ years of relevant experience in vaccines, biologics, or advanced therapies.
• Master’s degree with 8+ years of relevant experience.
• Bachelor’s degree with 10+ years of relevant experience.

Preferred Expertise

• Proven experience in the manufacturing of sterile drug products at pilot or commercial scale.
• Strong knowledge of cGMPs and ICH Quality norms in Manufacturing Science and Technology.
• Familiarity with Digitalization, Industry 4.0, and Data Analytics applications.
• Experience applying Quality by Design (QbD) principles in process development and lifecycle management.
• Experience with implementing platforms and standard work in CMC commercialization, technical operations or manufacturing
• Experience with process modeling, and development of scale-up and scale-down models
• Proficiency in Design of Experiments (DoE) and statistical data analysis.
• Experience in authoring and reviewing CMC regulatory documentation.
• Financial acumen with experience in resource forecasting and budgeting.

Travel Requirements

• Willingness to travel approximately 10% of the time.

Join Us

We are looking for innovative and adaptable leaders who are passionate about making a significant impact in the biopharmaceutical industry. If you are ready to bring your disruptive thinking and collaborative spirit to our organization, we invite you to apply and help us continue our mission of Inventing for Life and Impacting Lives while Inspiring Your Career Growth.

This position is specifically focused on building a Center of Excellence for Sterile Drug Product Commercialization in Pennsylvania and the surrounding regions.

Current Employees apply HERE

Current Contingent Workers apply HERE

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 click here 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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$169,700.00 - $267,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Analytical Thinking, Analytical Thinking, Animal Vaccination, Applied Engineering, Biopharmaceutical Industry, Biopharmaceuticals, Business Development, Clinical Manufacturing, Continual Improvement Process, Driving Continuous Improvement, Employee Development, Good Manufacturing Practices (GMP), Maintenance Supervision, Management Process, Manufacturing Equipment, People Leadership, Pharmaceutical Process Development, Production Process Development, Project Resource Allocation, Project Resource Management, Regulatory Compliance, Regulatory Documents, Resource Management, Results-Oriented, Social Collaboration {+ 5 more}

 Preferred Skills:

Job Posting End Date:

08/6/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.