Job Description

The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility that enables and advances our best work. The facility supports early clinical supply based on a seamless connection and collaboration between process development and clinical manufacturing.

We are currently seeking a Director leval Packaging and Distribution Lead who will be responsible for the on-time packaging and distribution of clinical supplies in compliance with evolving cGMP, GDP and company procedures. The Packaging and Distribution Lead will report to the Executive Director Clinical Supply Operations (CSO) and will be a member of the local Leadership Team in Schachen and will influence the strategy of CSO at the site as well as on a global level.

Responsibilities:

• Oversee all operations in clinical packaging and distribution

• Manage packaging and distribution scheduling including problem solving and proactive escalation the next level management if needed

• Ensure clinical supplies are processed according to cGMP, GDP and appropriate safety requirements to meet standards defined by the FDA and EU or other international agencies

• Capacity modeling and resource management in packaging and distribution; appropriate resource allocation and alignment between packaging and distribution

• Responsible to control scheduling activities and ensure collaboration across other GCS work centers to enable business continuity and portfolio needs

• Implement, oversee and maintain a 5S area.

• Official representative of CSO Schachen during CSO Schachen budget review, distribution siting meeting, site and global EHS committee, site project meetings (with FM)

• Oversee and responsible for the local CSO PMO activities, coordination of a monthly project review meeting

• Oversee investments in CSO Schachen (e.g. facility, equipment) and ensure cost control

• Sample request and storage optimization (internal and external)

• Oversee supplier relationship management, responsible for interaction, coordination, trainings, performance, escalations, and compliance for both Internal 3PL partner and multiple external transport suppliers.

• Organization and coordination of regular business meetings with external partners, driving continuous process optimization, improvements, and efficiencies.

• Ensure efficient and compliant processes; including review and harmonization of all SOPs with our packaging sites in the US. After harmonization, simplification and quality alignment to ensure agility and speed can be accommodated as required for the portfolio

• Point of contact and responsible for the area during audits and inspections and develop corrective action plans to address observations identified during audits and inspections.

• Seek ways to innovate and work smarter, removing barriers for the team and supports change as needed

• Close collaboration with Quality, Procurement, Finance, FM and EHS as well as other global GCS departments

• Ensure on-time training for people in the team according to the learning schedule

• Regularly evaluate employee performance, hold employee development discussions and conduct regular performance reviews in Packaging and Distribution

• Member of the local CSO leadership team

Requirements:

• Minimum Bachelor's degree preferably in Engineering or Pharmacy/Biology/Chemistry Sciences.

• An advanced degree is preferred but not required. An MBA or other business degree, in addition to the required science or engineering education, is beneficial.

• At least 10 years’ experience in a technology and/or operations management role within the pharmaceutical industry.

• Experience with pharmaceutical packaging (primary packaging of solid dosage forms, secondary packaging of vaccines/ biologics, medical devices).

• Strong compliance mindset and understanding of cGMP, including FDA and EMEA and GDP (Good Distribution Practice)

• Demonstrated ability in leading large teams and mentoring and developing talents.

• Ability to work effectively across boundaries to build strong collaborative relations with other groups.

• Demonstrated strategic 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 such as Six Sigma and Lean methods principles and tools.

• Strong abilities in Stakeholder Management and building and strengthening cross-functional networks.

• Strong communication skills in English and German

Preferred:

• Project Management certification

• Six Sigma certified Green or Black Belt

+Schachen, Canton Lucerne

Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.

Required Skills:

Accountability, Continuous Process, Ensure Compliance, Manufacturing, Problem Solving, Safety Procedures

Preferred Skills:

Audits Compliance, Audits Compliance, Business Planning, Business Process Development, Change Management, Communication, Compliance Monitoring, Computer Networking, FDA Regulations, Financial Auditing, Group Problem Solving, Leadership, Lean Process Improvements, Lean Six Sigma (LSS), Operations Management, Packaging, Policy Development, Process Improvements, Process Planning, Production Coordination, Production Operations, Production Planning, Production Processes, Production Scheduling, Product Packaging Design {+ 6 more}

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:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/9/2026

*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.