Director Clinical Supply Operations Packaging Lead

Job Description

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

Position Overview -Basic Functions & Responsibility:

Global Clinical Supply (GCS) organization is within our Company's Research Laboratories and is accountable for managing the 'end-to-end' integrated clinical supply chain across all our Research & Development Division portfolio to enable the execution of any clinical trial using our Company's asset. GCS supports more than 300 Phase I-IV clinical trials run inhouse, 400+ outsourced or run by partners as well as our Company's IIS clinical trials (300+). GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites across more than 60+countries, all in accordance with US and WW regulations, company policies and Standard operating procedures.

West Point site is the biggest site in our operations network. The packaging team plays a critical role in the clinical supply chain and flowless execution is paramount to meet the timelines and ensure business continuity for the portfolio. The Execution Operation head will be part of the WP CSO LT

The role is accountable of ensuring end to end operational excellence and execution in the packaging space of global clinical supplies executed in WP and is also accountable of the day-to-day management of the vendors supplying components and machinery necessary for execution of our products.

The Director will be a key part of WP CSO leadership team and as such will actively collaborate in update WP CSO strategy.

As organizational leader the role will be accountable to shape packaging and distribution (execution center) organization to the current needs of the CS (Clinical Supplies) chain and our Research & Development Division portfolio.

Primary activities include, but are not limited to:

• Oversee all operations and packaging floor in buildings 78A and 69D; including reconfiguration of current space to maximize throughput, staff utilization to minimize errors, and ensuring audit preparedness at all times.
• Ensure efficient and compliant processes; including review and harmonization of all SOPs with WAG and Rahway. After harmonization, simplification and quality alignment to ensure agility and speed can be accommodated as required for the portfolio
• Controls scheduling activities and ensure collaboration across other GCS work center to enable business continuity and portfolio needs
• Talent attraction, development and retention
• Performance management; including utilization of existing P3 and P4 to begin managing contractor and our Company's CPT staff
• Capacity modeling and resource management; including presentation to LT and maintenance of metrics for each role within the packaging floor
• Oversight of execution of vendors in the component and machinery space in collaboration with cross-functional internal groups
• Close collaboration with Quality, Procurement, Finance, other GCS departments
• Alignment with WAG, including partner group interaction optimization (Distribution, LR, Ops Planning, Quality, Master planning, Bulk manufacturing, Analytical for cleaning/swabbing/investigations)
• Close collaboration with GCTO and Regulatory to ensure regulatory needs are included in the CFGs and on time arrival of our products are ensured right first time
• Seek ways to innovate and work smarter, removing barriers for the team and supports change as needed
• Lead a mixed team of our Company employees, union and contractors

Education & Experience:

• 25 years of experience in Clinical Supply Chain and/or Clinical trials including exposure to Quality and or continuous improvement activities OR Master's degree with 10 years of experience OR Bachelor's degree with 15 years' experience
• Understanding of clinical supply needs and GMP, experience in operations within a GMP environment with supply chain
• Strong understanding of cGMP, including FDA and EMEA requirements.
• Experience in packaging will be highly valued
• Experience in leading teams, developing talent, mentoring or leading complex projects

Preferred Experience and Skills:

• Operations Management Certification (I.e., APICS)
• Six Sigma certification (i.e., Green or Black Belt).
• Project management, lean six sigma, scheduling practices preferred

• Able to organize a large team, upskill talent, and motivate for future success
• Comfortable with excel and Microsoft systems
• A dedication to solving complex and challenging problems with a creative mind and imaginative strategies.
• Understanding of scheduling and capacity modeling to ensure appropriate resourcing
• Ability to prioritize
• Demonstrated ability to communicate clearly, effectively with different global professional levels and external stakeholders

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are ...

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Know Your Rights

EEOC GINA Supplement

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Learn more about your rights, including under California, Colorado and other US State Acts

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:
On-Site

Shift:
1st - Day

Valid Driving License:
Yes

Hazardous Material(s):
N/A

Requisition ID:R240966