Job Description

Job Summary:

We are seeking a dedicated employee to support Global Clinical Supplies Operations at our West Point, PA facility. The Manager within Clinical Packaging Operations is responsible for providing direction and oversight to clinical packaging technicians (CPTs) that execute primary and secondary packaging in support of our clinical pipeline. In Global Clinical Supply, we are partnering across our internal packaging facilities, external contract manufacturers and suppliers to create an interdependent global manufacturing network committed to deliver a compliant, reliable supply of clinical finished goods to clinical sites and patients on time, every time, across the globe.

The individual is expected to embody enterprise leadership skills to coach the shop floor and enable the execution of packaging completion to meet the West Point Packaging, Clinical Supply Operations (CSO) and Global Clinical Supply (GCS) strategic priorities.  The manager maintains compliance and ensures execution excellence through making problems visible, removing obstacles and installing the right solutions to enable reliable supply. This role partners with the shopfloor specialists to ensure that products are manufactured and tested according to approved processes and comply with all applicable regulatory and internal requirements.  The qualified candidate must demonstrate strong critical thinking and scientific acumen to assist with troubleshooting of processes and systems.  Excellent leadership capabilities, including cross-functional collaboration, written and verbal communication skills, structured problem solving, disciplined decision-making, and talent management are required.  

Primary activities:

• Directly leads activities in the packaging IPT. This requires shopfloor presence and gowning.
• Coordinates and directs a team of clinical packaging technicians
• Micro level scheduling to ensure personnel assigned to jobs as well as availability of maintenance, environmental monitoring and other scheduling needs directly pertaining to shopfloor execution
• Ensure personnel operate within established policies/procedures of our Company and in compliance with cGMPs and all applicable government regulations. Escalate compliance and product quality concerns within packaging and coordinate with quality to resolve.
• Responsible for hiring and ensuring personnel are trained and performing per expectations.
• Manage and coach the team (direct and indirect reports) to deliver strong results while developing individual and team capabilities. Provide feedback to functional service providers (FSPs) for their staff performance.
• Acquire and maintain technical process knowledge relevant to operations. Ensure that documentation and products manufactured comply with all applicable standards and procedures, and governing regulations.
• Proactively identify and implement continuous improvement actions to solve problems and implementation corrective and preventative including but not limited to reducing deviations, reducing lead-time, increasing utilization and efficiency, improving safety and eliminate waste, while maintaining compliance.
• Review and approve production orders, standard operating procedures (SOPs) and other shopfloor centric documentation.
• Ability to serve as a subject matter expert to support quality risk assessment and other quality management system support

Minimum Education Requirements and Experience:

• Bachelor's Degree in Science, Engineering, or another technical field with four (4) or more years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain within pharmaceutical manufacturing OR 
• Associate’s degree in science, Engineering, or another technical field with six or more (6) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain OR
• High school diploma with eight (8) or more years experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain

Required Experience and Skills:

• Experienced in risk based Decision Making- Identifying and understanding problems and opportunities by gathering, analyzing and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences.
• Demonstrated leadership and management experience working with cross-functional teams on objectives to deliver on Key Performance Indicators
• Inclusion- ability to create an engaged workforce using Inclusion as the How and resolve minor conflicts to enable stronger execution and collaboration among the team
• Evidence of good verbal and written communication skills, i.e., effective presentation of concepts and ideas, as well as strong interpersonal skills

Preferred Experience and Skills:

• Manufacturing Operations supervisory experience; Minimum one (1) concurrent years’ experience managing direct reports.
• Working Across Sites and Functions – Must possess excellent interpersonal, communication, collaboration, and negotiation to win as one team
• Talent Growth/Coaching/Development- Demonstrated ability to build knowledge/capability and help highlight individuals’ strengths as well address unsatisfactory performance
• Demonstrated experience with quality systems such as deviation management and quality risk management
• Knowledge and practice with MPS/Lean/Six Sigma/8 Step Problem Solving/Tier

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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.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Relocation:

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