Job Description

Summary:

Global Clinical Supply Operations is seeking a highly motivated individual to support the clinical supply operations packaging organization, including first-line leader for day-to-day operations activities. Adherence to regulatory, global and site policies and procedures governing activities is critical.

In addition to future state operational activities, this position is responsible for supporting the launch of a new cold chain packaging facility and for providing day to day tactical direction to the team of Clinical Packaging Technicians, ensuring that business objectives are met and that a high standard for Quality and Safety compliance is maintained. The position will also be expected to promote behaviors of continuous improvement and ensure that the Packaging team maintains an inclusive culture that supports positive employee relations.

Core Responsibilities:

Process Execution | Continuous Improvement

• Work independently to collaborate and influence cross-functional teams including Quality/Compliance, Engineering, EHS, and Project Leads.

• Lead and support mock runs and internal audits to ensure operational readiness for the facility.

• Serve as a Subject Matter Expert (SME) to provide area/process overview information to visitors/auditors upon request.

• Author, review and approve SOPs related to operational changes.

• Author and/or participate in investigations of atypical events and clinical complaints, as needed.

• Work to prepare a room or batch for packaging activities, including the creation of appropriate Packaging documentation as needed.

• Partner with other groups, including Quality, Label Room, Distribution Center, Operations Planning, Master Planning.

• Coordinate complex packaging jobs and serve as technical contact for Packaging Technicians and Operations Planners as needed.

• Ensure correct documentation of transactions within SAP and perform pre-execution and post-execution reviews of batch documentation as per procedures.

• Lead or participate in walkthroughs of areas/processes to identify process improvements and ensure adherence to regulatory requirements.

• Execute Corrective/Preventative actions stemming from walkthrough observations and/or investigations, as needed.

• Review area alarms and log completions to ensure compliance.

• Track area performance related to Key Performance Indicators and determined root cause and trending of misses.

• Train cross-functionally to support Distribution and Labeling activities based on operating model.

Leadership | Communication

• Provide a leadership presence on the packaging floor.

• Support daily (Tier) meetings to facilitate flow of information up/down through the organization.

• Facilitate regular huddle meetings to cascade information and collect team feedback.

• Provide regular feedback and coaching to employees on work performance.

• Ensure a culture of inclusion and consistency is maintained, supporting positive employee relations at the packaging floor level within the team and site.

• Review Technician performance and system entries to ensure accuracy and compliance.

• Regularly help the team troubleshoot issues to minimize downtime and maintain product quality.

• Identify opportunities to improve the process (e.g. cycle times, ease of execution, reliability)

• Support work as needed to implement improvements (e.g. scheduling, staffing, protocol execution)

• Champion standard work to drive consistent use of best practices.

• Represent Operations on project teams as needed.

• Participate in continuous improvement initiatives across clinical supply operations.

• Assist packaging leadership team with development of objectives and ensure alignment with site goals.

• Escalate issues as needed to ensure the right support/awareness is given to issues as they arise.

• Maintain training and compliance with site safety and quality requirements.

• Participate in safety/regulatory audits (i.e. tours, topic discussion)

• Foster strong and effective safety culture on the team through actions, coaching, and prioritization.

Education:

• Bachelor's Degree and a minimum of 4 years' experience in Technical Operations, related Business Operations or Good Manufacturing Practice (GMP) regulated environment, with specific experience in Clinical Pharmaceutical Packaging.

Required Experience & Skills:

• Ability to operate effectively independently and collaboratively within teams

• Ability to manage multiple priorities and coordinate people/resources to meet a production schedule

• Outstanding decision-making skills and strengths in project management and team alignment

• Knowledge of cGMPs, data management, collection, and analysis

• Proficient in Microsoft Office (Word, Excel, etc.)

• SAP (or equivalent) experience strongly preferred

• Strong interpersonal, communication, organizational and problem-solving skills, coupled with the ability to engage and influence cross-functional stakeholders

Preferred Experience and Skills:

• Experience with clinical manufacturing and/or packaging operations and demonstrated ability to deliver on a fluid demand schedule.

• SAP (or equivalent) experience

#eligibleforERP

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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:

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.

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

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R337637