Merck West Point, PA 19486
**Job Description**
Reporting into an Executive Director Packaging Technical Operations the Director Packaging Platform Technical Leadership will be responsible and accountable for technical support and stewardship of key packaging and assembly platforms including components, processes, and equipment. The steward organization is responsible for establishing and maintaining the platform standards covering all our company's Human Health products, small molecules, biologics, and vaccines including the standard platform finished goods images as well as packaging and assembly equipment standards. The Director will lead a team of technical experts and will collaborate cross-functionally to ensure the development and execution of robust technical lifecycle management plans including proactive risk management strategies, and continuous improvement initiatives to guarantee the safety, effectiveness, and compliance of our company's product portfolio across the internal and external network.
The successful candidate will have organizational, technical, and project leadership experience commensurate with leading a global, cross-modality technical team. The leader will also be responsible for the professional development of team members, as well as establishing and executing on priorities for the organization, managing budget and capability investments and the successful completion of projects, through strong scientific excellence, technical rigor, robust problem solving and strategic decision making. The candidate will be expected to build inclusive, collaborative partnerships with internal and external stakeholders such as packaging and manufacturing sites, analytical, regulatory and project leaders. The successful candidate will display ownership and make informed cost/benefit decisions based on analysis of inputs, outcomes, risks, and company-wide prioritization.
**Essential Responsibilities:**
+ Provide strategic leadership and direction for technical support and platform stewardship, including managing ongoing changes as well as design and tech transfers for the components, equipment, and processes. Develop, maintain, and refine technical platform lifecycle management plans, setting and managing and optimizing platform standards.
+ Collaborate with cross-functional teams and stakeholders to ensure that all platforms (e.g. syringes, vials, bottles, blisters, auto injectors, kits) meet safety, efficacy, and quality, and robust supply standards.
+ Lead, mentor, and develop a team of technical staff, providing guidance on industry best practices and fostering a culture of continuous improvement.
+ Oversee lifecycle changes for packaging platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards. Ensure thorough engineering and packaging science is applied to deliverables for new product introductions and tech transfers across the network inclusive of aligning the control and validation strategies.
+ Drive scientific rigor, technical problem solving and execution excellence including interrogation of the data/ science through technical reviews and exploring alternative ways to view and solve problems to achieve results.
+ Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
+ Develop and maintain strong relationships with internal stakeholders, including commercialization, quality, analytical, regulatory, manufacturing, Technical Product Leaders and Value Chain to facilitate effective technical support and platform stewardship. This includes above site support for significant investigations, complaints monitoring and rapid response activities.
+ Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical platform stewardship activities. Manage the portfolio of work in the organization, holding the team accountable to deliver on priorities
+ Build the best talent and provide proactive support, active leadership and coaching to team members, as well as managing performance
**Minimum Education Requirements and Experience:**
+ Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years relevant experience pharmaceutical packaging, combination product assembly and packaging, or related technical fields; **OR**
+ Master of Science (MS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years relevant experience pharmaceutical packaging, combination product assembly and packaging, or related technical fields; **OR**
+ PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant experience pharmaceutical packaging, combination product assembly and packaging, or related technical fields
**Required Skills and Experience:**
+ Demonstrated experience in a leadership role, managing technical teams, technical product stewardship or related functions.
+ Strong understanding of packaging and medical device and combination product commercialization and tech transfer, assembly and packaging process improvement and support from early stage through launch and supply, including components, process, and equipment, as well as qualification and validation.
+ In-depth knowledge of global regulatory requirements for packaging and medical devices and combination products and packaging.
+ Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
+ Able to guide key activities including new product and platform development and maintenance, standard work development and investigations.
+ Strong problem-solving and decision-making skills with an ability to determine interrogate the science, identify true requirements, and detect critical flaws
+ Proven track record of driving continuous improvement and implementing best practices in technical support and product stewardship.
+ Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support and product stewardship.
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:
$153,800.00 - $242,200.00
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:**
Domestic
**VISA Sponsorship:**
No
**Travel Requirements:**
10%
**Flexible Work Arrangements:**
Hybrid
**Shift:**
1st - Day
**Valid Driving License:**
No
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
02/11/2025
***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:** R332055