Associate Director, Packaging Development Lead

Job Description

Reporting to the Director of Packaging Commercialization, the Associate Director, Engineering, Packaging Commercialization will lead packaging development for new oral solid dosage and parenteral products including small molecules, biologics, and vaccines. This role involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging as well as prior experience developing and commercializing new products on cross-functional teams.

The Associate Director will be accountable for the definition and execution of overall packaging strategies that meet global network needs. Responsibilities include ensuring packaging system designs are robust, packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs. They will ensure activities supporting these program deliverables are executed with technical rigor and drive risk understanding and reduction prior to product launch. The packaging development lead will be accountable for technical risk assessments, packaging specifications, and qualification activities, while ensuring compliance with all regulatory standards and sustainability goals. Individuals in this role will lead with ownership and accountability for representing, communicating, and balancing the interests of stakeholders. They will have an ability to effectively drive the right risk posture that balances technical probability, cost and resources, and trade-offs across 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.

Minimum Education Requirement and Experience:

• 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
• Master of Science (M.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with eight (8) years of relevant pharmaceutical development experience; OR
• PhD in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with five (5) years of relevant pharmaceutical development experience

Required Experience and Skills:

• Demonstrated understanding of pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components
• Demonstrated understanding of Medical Device and Combination Product regulations
• Demonstrated understanding of the use of Risk Assessment tools
• Demonstrated ability to work both independently and as part of a larger team
• Demonstrated experience in leading cross-functional groups both internally and externally
• Demonstrated 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
• Demonstrated knowledge of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging
• Strong interpersonal skills and the demonstrated 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 Experience and Skills:

• Medical Device and Combination Product Packaging development experience
• 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.

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US and Puerto Rico Residents Only:

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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.

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• 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:R333203