Job Description

Reporting to the leader of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is responsible and accountable for packaging development activities from packaging design concept through launch, strategic management of the sterile development portfolio, and delivering on organizational unit priorities. The Director will be responsible for new product packaging development for vaccine and biologic dosage form products, including Medical Device and Combination Products (MDCPs) in the human health portfolio.

The successful candidate will have organizational, technical, and project leadership experience commensurate with leading a technical organization responsible for development and commercialization of a portfolio of products. The Director will manage a team of scientists and engineers who are responsible for delivering robust packaging systems for cell banks, drug substance, drug product, and finished goods. Development activities include the design, characterization, qualification, and tech transfer of robust packaging systems to commercial sites, as well as packaging process co-development with commercial device assembly and packaging sites. Additionally, the successful candidate will have demonstrated understanding and experience of unique requirements of packaging system development of Medical Device and Combination Products, including pre-filled syringes and autoinjectors.

This Director will be responsible for the professional development of team members, as well as driving transformation within the broader Packaging Commercialization organization, overseeing budget and capability investments and the successful completion of projects, ensuring strong scientific excellence and strategic decision making. The candidate will be expected to build inclusive, collaborative partnerships with internal and external stakeholders such as drug substance, drug product, device, analytical, regulatory, project leaders, manufacturing sites, and other key stakeholders in CMC development and packaging operations. The successful candidate will model ownership and define informed strategies based on analysis of inputs, outcomes, risks, and enterprise-wide prioritization.

Primary Responsibilities include:

• Lead a sterile product group, accountable for people and operations, including managing a sterile portfolio budget, business process optimization, and employee development.
• Provide technical direction and oversight of engineering of sterile product packaging systems, including pre-filled syringes and autoinjector combination products
• In collaboration with other sterile and non-sterile portfolio group leads, introduce and improve standard work processes supporting packaging development core deliverables.
• Provide leadership in areas of problem solving, risk identification and mitigation, and scenario planning in support of teams bringing new products to market.
• Work in collaboration with other development functions including Drug Product, Device, Analytical, and Drug Substance to ensure thorough science and engineering are underpinning deliverables
• Work in collaboration with packaging site technical and operations groups to optimize processes for technical and knowledge transfer of new products to the device assembly and packaging sites.
• Build talent and provide proactive support in training and coaching to team members
• Remain informed of current quality and regulatory requirements and industry trends as described in worldwide regulations and industry standards
• Maintain an active network of practitioners and resources in relevant fields of expertise
• Demonstrate financial stewardship in all areas of responsibility

Minimum Education Requirement and Experience:

• Bachelor of Science (BS) Degree in life sciences or equivalent with at least fifteen (15) years of relevant experience. OR
• Master of Science (MS) Degree in life sciences or equivalent with ten (10) years of relevant experience. OR
• PhD in life sciences or equivalent with seven (7) years relevant experience.

Required Skills and Experience:

• Demonstrated ability to manage teams
• Advanced understanding of Medical Device and Combination Products (e.g. pre-filled syringes, autoinjectors)
• Strong strategic and business acumen
• Ability to provide clear, unambiguous expectations and priorities for direct reports
• Demonstrated ability to collaborate and effectively communicate with a diverse set of stakeholders and sponsors
• Ability to resolve conflicts among people and organizations
• Strong leadership, facilitation, and listening skills
• Ability to manage through uncertain situations and to develop appropriate plans for managing risk
• Ability to determine true requirements and detect critical flaws
• Ability to recognize, motivate, and reward team members

Preferred Skills and Experience:

• Post-degree experience is required, gained in packaging science or engineering, process engineering, packaging production operations, device development and commercialization, leading cross-functional product development teams, or equivalent.
• Strong leadership skills, including team facilitation across multiple functions
• Prior people management experience
• An enthusiasm for collaboration with a diverse set of business partners within research, development, and supply, at a variety of locations within and external to our company
• Strong interpersonal collaboration and communication skills and the ability to manage projects and lead discussions with partners from other functional areas when conducting risk assessments, designing experimental test plans, and seeking to utilize materials and resources outside the control of packaging commercialization
• Strong project and time management skills to allow for the ability to successfully track multiple project assignments at a variety of different stages of development.

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:

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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:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Applied Engineering, Applied Engineering, Applied Mathematics, Business Management, Business Performance Management, Business Process Management (BPM), Client-Focused, Client Relationship Building, Collaborative Communications, Compliance Packaging, Confidentiality, Effective Listening, Engineering Standards, Leadership, Leading International Teams, Life Science, Management Process, Manufacturing Scale-Up, Medical Devices, Packaging Engineering, Packaging Innovation, Packaging Processes, Packaging Technologies, People Leadership, Product Packaging Design {+ 5 more}

Preferred Skills:

Job Posting End Date:

07/8/2025

*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.