Packaging Technical Lead (Associate Director)

Caraway Therapeutics, Inc.; Rahway (NJ); On-site; USD 129,000 - 203,000; Full time

Job summary

Merck is seeking an Associate Director of Packaging to define and execute global packaging strategies. The role leads technical risk assessments, packaging specifications, and qualification activities while ensuring regulatory compliance and sustainability goals.

The successful candidate will have expertise in primary, secondary, and tertiary packaging systems, including blow-fill-seal technologies, and will collaborate across CMC teams to bring new products to market.

Qualifications

• Bachelor of Science in Packaging Engineering or related field with 10 years of pharma development experience, or MS/PhD with 8 years.
• Understanding of pharmaceutical development processes and packaging components; ability to design and test packaging elements.
• Experience with risk assessment tools and leading cross-functional teams; strong communication skills.
• Knowledge of current US/global regulations, ICH, ISO standards, and quality systems for packaging.

Responsibilities

• Define and execute packaging strategies meeting global network needs.
• Lead technical risk assessments, develop packaging specifications, and oversee qualifications.
• Ensure compliance with regulatory standards and sustainability goals.
• Represent stakeholders and balance interests across functions.
• Collaborate across the end-to-end CMC continuum to develop new products.

Skills

Coordinate

Change Management

Collaborative Leadership

Cross-Functional Teamwork

Detail-Oriented

Deviation Management

Engineering Standards

Global Coordination

GMP

ISO Compliance

Packaging Engineering

Procedure Writing

Process Definition

Process Optimization

Project Leadership

Project Management Leadership

Project Team Management

Education

B.S. in Packaging Engineering

M.S./Ph.D. in relevant field

Tools

Blow-fill-seal tech

Job description

Job Description

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. We are seeking an Associate Director, Packaging, to join our team and lead the definition and execution of overall packaging strategies that meet global network needs.

TheAssociate Directorwillbe accountable forthe definition and execution ofoverall packaging strategiesthat meet global network needs.Responsibilitiesincludeensuring packaging system designs are robust,packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs. They willensure activities supportingthese program deliverablesareexecuted with technical rigoranddrive risk understanding and reduction prior to product launch. The Packaging Technical lead will be accountable fortechnical risk assessments, packaging specifications, and qualification activities, while ensuring compliance withallregulatory standards and sustainability goals.Individuals in this role will lead with ownership and accountability forrepresenting, communicating, and balancing the interests of stakeholders. Theywill have an ability to effectively drive the rightriskposture that balances technical probability, costandresources, andtrade-offsacross various groups.The role requires strong technical skills, problem-solving abilities, and the capacity to navigate complex situations in a fast-paced environment, all while aligning packaging with product and patient needs.

The successful candidate will bring expertise in the design of primary, secondary and tertiary pharmaceutical packaging systems, including blow-fill-seal technologies. They will collaborate with stakeholdersacrossthe end-to-end continuum of CMCareasand requireboth anunderstanding of packaging components and processes, as well as prior experience developing and commercializing new productsoncross-functionalteams.

Responsibilities

• - Ensure packaging system designs are robust, packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs.
• - Drive risk understanding and reduction prior to product launch.
• - Conduct technical risk assessments, develop packaging specifications, and oversee qualification activities.
• - Ensure compliance with all regulatory standards and sustainability goals.
• - Represent, communicate, and balance the interests of stakeholders.
• - Drive the right risk posture that balances technical probability, cost, resources, and trade-offs across various groups.
• - Collaborate with stakeholders across the end-to-end continuum of CMC areas.
• - Develop and commercialize new products on cross-functional teams.

Qualifications

Required

• - Bachelor of Science (B.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with ten (10) years of relevant pharmaceutical development experience; OR MS/PhD with 8 years
• - Demonstrated understanding of pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components.
• - Demonstrated understanding of the use of Risk Assessment tools.
• - Ability to work both independently and as part of a larger team.
• - Experience in leading cross-functional groups both internally and externally.
• - Experience with blow-fill-seal technologies for sterile pharmaceutical packaging systems.
• - Project management experience and ability to provide technical leadership for complex projects while managing multiple projects in a fast-paced environment.
• - Excellent technical written and oral communication skills that support presentation of information clearly and concisely for all levels of the organization.
• - Knowledge of current US and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging.
• - Strong interpersonal skills and the ability to influence senior leaders.
• - Ability to manage complex programs and support multiple activities/projects.
• - Willingness to grow and learn all areas of Pharmaceutical new product development.

Preferred

• - Medical Device and Combination Product Packaging development experience.
• - Quality Risk Management, Risk-Based Decision Making, and Quality by Design (QbD) experience.
• - Experience in defining standard work processes and documents.
• - Experience specifying, processing, and characterizing packaging materials including rigid and flexible barriers, pulp/paperboard, and recyclables.

Required Skills:
- Ability to Coordinate, Ability to Coordinate, Change Management, Collaborative Leadership, Combination Products, Competency Management, Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Global Coordination, Good Manufacturing Practices (GMP), Group Processes, ISO Compliance, Legal Compliance, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Procedure Writing, Process Definition, Process Optimization, Project Leadership, Project Management Leadership, Project Team Management {+ 10 more}

Preferred Skills:

US and Puerto Rico Residents Only:

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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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The salary range for this role is
$129,000.00 - $203,100.00

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 .

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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
10/21/2026
*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.