**Job Description** Reporting into a Director in Packaging Commercialization, the Associate Director Design Technical Lead will provide technical expertise from initial design concept through product launch with a primary focus on biologic and vaccine drug substances, drug products, and medical device combination products (MDCPs) in the Human Health portfolio. The candidate will also influence oral solid dosage form packaging design, as needed based on complexity. The successful candidate will understand considerations of complex packaging design and the interplay between product and package including component and material selection, package design attributes, packaging process considerations, impact of environmental and distribution hazards, and potential sources of variability. They will have a proven track record of proactive risk identification and mitigation through structural and materials design optimization. In Packaging Commercialization, his individual will be responsible for working collaboratively with other engineers to influence the data-driven development of packaging systems for sterile and non-sterile products from conception through successful launch and supply. Beyond package design, the Associate Director will focus on upskilling fellow packaging engineers on risk-based experimental design and data analysis, considerations when designing for common assembly and packaging equipment, and considerations for packaging material selection, including new sustainable materials. The candidate will be expected to build inclusive, collaborative partnerships with internal and external stakeholders such as packaging and manufacturing sites, analytical, regulatory, project leaders, and other key stakeholders. The successful candidate will display ownership and proactively identify opportunities to build technical rigor into standard work and packaging platforms. 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:** + End-to-End experience in packaging of pharmaceutical and/or medical device / combination products including data-driven design development and selection,process engineering, production, and operations + Demonstrated knowledge of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging + Experience with a variety of primary, secondary, and tertiary packaging types common in the biopharmaceutical industry including bottles, blisters, pouches, vials/cartons, prefilled syringe packaging systems, and/or auto injector packaging systems and the considerations for manufacturability of designs + Use of design and modeling tools to enhance understanding of distribution stresses and packaging dynamics + Ability to determine interrogate the science, identify true requirements, and proactively detect critical flaws + Enthusiasm and leadership skills to enable collaboration with diverse business partners within and outside the company. + Ability to drive complex projects to completionby translating goals to actionabledeliverables that are effectively tracked in a fast-paced environment. + Demonstrated ability to navigate ambiguity, embrace experimentation and learning, and model a growth mindset. + Ability to identify technical capability gaps in the organization, create/build resources to address those gaps, and ability to influence other engineers. + Excellent technical written and oral communication skills that support presentation of complex technical information clearly and concisely for all levels of the organization, including stakeholders and sponsors. + Proficient in the areas of problem solving, risk-based decision-making, and use ofstandard work. + Demonstrated ability to maintain subject matter expertise and help the organization grow and learn in packaging development.   **Preferred Experience and Skills:** + Demonstrated background in application of numerical design and modeling tools to enhance understanding of distribution stresses and packaging dynamics + 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. + Expertise in hypothesis development and testing, statistical analysis, and Design of Experiments + Lean Six Sigma or Design for Six Sigma certification. Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) **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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process. 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: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) EEOC GINA Supplement​ Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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 (https://www.msdprivacy.com/us/en/CCPA-notice/) **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: $126,500.00 - $199,100.00 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 (https://www.benefitsatmerck.com/) . **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:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 02/28/2025 ***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:** R336859