Job Description

This position is responsible for all operational aspects of the preparation of clinical supplies. This includes scheduling, coordination and oversight of label production, packaging, distribution of clinical supplies in contract manufacturers in compliance with evolving cGMP and company procedures. Specifically, the responsibilities include:

Planning

• Ensures that Planning documents for packaging of clinical supplies are processed according to cGMPs.

• Ensures that the actual workflow progress is captured in the workflow management system.

• Reports status of Planning documents for packaging to Planning Manager

• Determine the packaging design in coordination with label specialist, label room, packaging, planning manager and comparator specialist

• Responsible to complete the operations part in the clinical supply specification.

• Responsible for creation of material masters, BOMs, recipes and the production versions, the release of process orders, print orders creation and electronic batch record generation in sap.

• Creates Quality notification/Batch Note in case of updates/changes related to the packaging activities.

• Tracks the progress of the jobs, coordinate issue resolution across various functions, if required and escalates issue and delays if necessary.

• Participates in trouble shooting meetings and/or provides input for resolution. • Analyzes and anticipates potential obstacles for project processing.

• Escalates issues, delays and critical situation in timely manner to planning manager

• Requests and negotiates timelines with the contract manufacturer.

• Requests and reviews quotes/purchase orders for outsourced jobs.

• Enters timelines in the job tracking database. • Approve the vendor generated batch record.

• Post-execution review of the batch record and submission to QA.

• Coordinate packaging job tracking meetings with the contract manufacturer.

General CSO coordination

• In collaboration with other internal sites, ensures best operational practices are adapted and followed in contract manufacturers.

• Maintains strong collaboration with key stakeholders, collaborates with internal peers and external partners (Manufacturing, vendors, planning, operations, quality, local clinical teams, regional team, etc.) to identify and resolve operational issues, improve supply chain efficiency and local clinical sites satisfaction.

• Assures compliance with global and site regulations (cGMP, Environment, Health and Safety, Controlled Substance, etc.) for all processes, equipment, and resources.

Support other initiatives

• Executes strategies for new capability acquisitions to support the clinical study portfolio expansion locally.

• Supports GCS ITN (integration, technology & network) team during due diligence and integration phases of local related deals.

• Partners with areas inside and outside of operations on cross-functional initiatives.

• Provides other support to global colleagues from local side.

• Completes additional tasks assigned by line manager.

compliance & sops

• Attends regular sop and gmp trainings.

• Follows compliance standards within the department (gmp, safety, internal policies)

• Ensures all processes are covered by sop

• Creates, maintains and updates all sop of related processes.

• Issues and deals with deviations, change requests and complaints related activities.

Education Minimum Requirement:

bachelor degree preferably in engineering, science or operations management. An advanced degree is preferred but not required.

Required Experience and Skills:

• experience with pharmaceutical manufacturing or primary and secondary packaging of different dosage forms.

• experience in planning, scheduling, coordination and processing of supply chain activities, or the equivalent.

• Fluent verbal language.

• Strong understanding of cGMP.

• Excellent Communication & Interpersonal Skills: ability to effectively communicate with stakeholders at various levels. Strong negotiation, influencing, and relationship-building skills to help alignment and collaboration. • Ability to work effectively across boundaries to build strong collaborative relations with other groups, domestically and internationally.

• Experience on contract manufacturer management.

• Demonstrated strong project leadership of cross-functional teams to deliver successful completion to project target milestone dates.

• Demonstrated ability to develop innovative solutions to undefined problems and business processes to meet the needs of key stakeholders and project sponsors.

• Experience with Operational Excellence methodology, Lean methods principles and tools.

• Technical proficiency: Familiarity with supply chain systems, software (sap or oracle) and demand/supply planning principles, office software

• strong analytical & problem solve skills.

• Flexible work hours: Be adaptable to meeting schedules, demonstrating strong time management skills to meet the needs of the team and work

Preferred Experience and Skills:

• Knowledge of clinical trials and associated supply chain

• Knowledge of clinical process

• lean certification (green or black belt).

• supply chain certifications

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/30/2025

*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:R330643