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Job Description

Job Description:

We are seeking a highly motivated individual for the role of Associate Director, Tech Transfer Leader supporting the Wilson Packaging Technical Operations Team. This role will drive end-to-end technical readiness for new product introduction and technology transfer at the site, including management of all activities required for the technical transfer of new and in-line products and processes.

The incumbent will have broad, experience-based skillsets in Technology Transfers with key focus on standards, technical robustness, and right first-time success for commercial scale device assembly and packaging technology and components. Experience also includes strong project management skills and utilization of program/portfolio management tools with demonstrated experience working with internal and external partners and stakeholders and influencing technical strategy.

Key Responsibilities:

+ Leading TT, Ensuring On-time Delivery: Manages and accountable for the overall technology transfer activities with end-to-end visibility to site deliverables for the device assembly and packaging process, analytical and facility readiness.

+ Partners with above-site Development and Commercialization teams on overall TT strategy and TT plan.

+ Single TT point of contact interfacing with the Development and Commercialization Teams, Packaging and Device Working Groups, VCMTs.

+ Ensure clear communication within Science & Technology, our Company at Wilson, and with leaders/stakeholders regarding technical / execution risks and progress vs. project plan.

+ Develop and manage integrated project plan and lead the end-to-end (incoming, manufacturing, release) readiness for new and in-line product introductions and Tech Transfer into the site with strong direct and indirect leadership and influencing skills.

+ Use Subject Matter Expertise with broad packaging and combination product experience (process, device assembly/packaging, equipment, components) in Tech Transfer / New Product Introduction to pressure test site readiness robustness through proactive risk assessment (technical and execution risks). Able to identify risks across functional areas/interfaces and develop robust mitigation actions. Able to operate effectively in face of ambiguity, supporting scenario planning and options analysis to support risk-based decision making.

+ Use Demonstrated end-to-end assembly and packaging operations technical breadth, including problem solving to lead technical team accountable for rigorous technical outcomes including process qualification and validation, component qualification, specifications, artwork profiles.

+ With the site team, develop/set strategy for the launches. Once in execution, transfer to run- the- business (Supply chain).

+ Schedule and facilitate technical reviews associated with tech transfer.

+ Accountable for After Action Reviews and knowledge sharing with other TT teams.

+ Required to comply with our Company Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.

+ Work collaboratively to drive a safe and compliant culture.

+ Builds strong cross-divisional partnerships with site leaders, functional management, and other stakeholders (Research & Development, Commercialization, Tech Ops, Ops, Quality, Analytical Regulatory-CMC, and Supply Chain, etc.)

Minimum Education Requirements and Experience:

+ Bachelor of Science (B.S.) in Engineering, or related field with seven (7) years of combination experience in relevant Device assembly/packaging, project management, and (cross-functional) leadership. **OR**

+ Master of Science (M.S.) in Engineering or related field with five (5) years of combination experience in relevant Device assembly/packaging, project management, and (cross-functional) leadership **.**

Required Skills and Experience:

+ Extensive technical knowledge and experience in device assembly and packaging processes for a diverse range of images (including vials, syringes, cartridges, autoinjectors, inhalers, bottles, and blisters). Proficient in facility, equipment, and operational controls for BSL and OEB 4/5 products.

+ Demonstrated technical expertise in product commercialization and lifecycle management across multiple platforms and modalities, with a focus on overseeing technology transfer from a site perspective.

+ Proficiency with change control and deviation management.

+ Strong knowledge of global regulatory guidelines and cGMP principles.

+ Demonstrated ability to create and analyze detailed, cross-functional project plans (including Gantt charting) and manage execution and change against those plans.

+ Manages effectively with diverse teams (cross-functionally, cross-culturally, and across internal / external sites) to align and drive TT results.

+ Effective verbal and written communicator who keeps stakeholders / partners apprised of plans, status, and issues.

+ Works well in ambiguity.

+ Able to articulate TT to others.

+ Establishes clear goals, delegates effectively, holds self and others accountable.

+ Flexible and adaptable to dynamic situations

+ Cross-functional team management; successful at indirect management.

+ Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.

+ Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others, using the diverse perspectives of others to generate ideas.

+ Well-developed and effective team facilitation and leadership skills; ability to establish inclusive team environments.

+ Demonstrated creative conflict resolution and problem-solving skills.

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.

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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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”.

**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:

Business Management, Business Management, Business Operations, Change Management, Combination Products, Communication, Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Management Process, Manufacturing Scale-Up, Mentorship, New Product Introduction Process, Packaging, Packaging Engineering, Process Optimization, Project Management, Project Planning, Risk Assessments, Risk Management, Root Cause Analysis (RCA), Scenario Planning {+ 5 more}

Preferred Skills:

Job Posting End Date:

06/11/2025

*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:** R350408