Director, Combination Product Commercialization

Job Description

Job Summary:

The Director, Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization. This position is responsible for providing strategic leadership, technical expertise, and project management in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and site-specific projects, facilitate technology transfer, and drive product robustness for sustained launch in alignment with the company's business goals, and quality and regulatory compliance.-

Essential Duties and Responsibilities:

Strategic Leadership and Project Management:

• Provide leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination products globally.
  
• Develop and execute strategic plans for technology transfer, problem-solving, leading working group in late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.
  
• Provide Voice of Manufacturing input to early development teams to ensure needs of manufacturing are considered as part of the design.- Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements for commercializing new products.
  

Technical Expertise:

• Utilize extensive experience in design controls, device transfer, control strategies device risk management, and design verification testing to develop value-added solutions for medical devices and combination products.
  
• Build and enhance device or combination product technology transfer programs in both development and lifecycle management, ensuring compliance with relevant regulatory standards.
  
• Ensure robust technical plans, risk communication, drive technical and programs decisions through the development team and governance forums
  
• Author and complete regulatory filing sections, and support response to questions and pre-approval inspections from a product development standpoint
  

Stakeholder Collaboration and Communication:

• Secure early sponsorship and stakeholder alignment for projects and initiatives, effectively communicating decisions and expectations to key stakeholders and sponsors.
  
• Foster a culture of inclusion by integrating inputs and perspectives from various sources to meet customer and stakeholder needs.
  
• Build strategic partnerships with manufacturing sites and partner groups
  

Team Management and Development:

• Lead, mentor, and enable the team to function as independent contributors, providing support for global and site-specific projects related to combination products and drug delivery systems.
  
• Facilitate the professional development and performance of team members, fostering a collaborative and innovative team environment.
  

Regulatory Compliance and Quality Assurance:

• Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company's divisional and local site procedures.
  
• Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.
  

Qualifications:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineer, or a related a technical field (e.g., Chemical Engineering, Materials Engineering) required; advanced degree (Master's or PhD) preferred.
  
• Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years in a leadership or management role.
  
• Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly, and packaging, with specific experience in autoinjectors, prefilled syringes, and complex drug delivery systems.
  
• Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance.
  
• Exceptional project management skills and principled verbal and written communication abilities, and prior experience leading combination product development teams and working groups
  

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
$153,800.00 - $242,200.00

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 .

You can apply for this role through (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:
25%

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Required Skills:
Business, Management Process, Social Collaboration

-Preferred Skills:

Job Posting End Date:
09/5/2025
*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.

Requisition ID: R360221