Job Description

Our Schachen site serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives.

The Biotech facility, at our Schachen site, is a state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions.  Our Company’s Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.

The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. A multi-product strategy for Technology Transfer and Facility Fit will enable the facility to adapt in a flexible and agile way for rapid product launch.

As leader of the Process Engineering group at Werthenstein BioPharma Facility, you will be responsible for the evaluation and implementation of novel equipment, innovative processes, and the implementation of next generation technologies to keep our Company at the forefront of innovation in development and clinical manufacturing of biologics.

The primary activities include but are not limited to the following activities:

Primary activities/responsibilities:  

Inspire Diversity and Inclusion – building effective working relationship within a cross-functional team across different cultures and backgrounds. 

Contributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own leadership and technical/functional skills 

Lead tiered meeting structure coordinating activities locally and with international (US, Ireland) groups for implementation of new processes and technologies for Drug Substance manufacturing.

Serve as a Subject Matter Expert for the implementation of new equipment to enhance manufacturing processes in a Good Manufacturing Practice (GMP) environment, preparing user requirements and capital funding requests.

Consolidate process-related knowledge and centralize it for efficient knowledge management.

Implement innovative technologies, software, and instruments to streamline processes and reduce the effort involved in manufacturing and administrative processes.

A Change and QRA Champion within the organization and site, to introduce new technologies, digitization, and identify opportunities for innovative work methods.

Responsible for the planning, allocation, and management of CAPEX projects to ensure efficient utilization of resources while adhering to budgetary constraints and timelines.

Providing technical and functional oversight for various large and small projects managed by the team.

People Manager activities/responsibilities:  

You will be responsible for establishing the vision and strategy for the Process Engineering Team. Additionally, you will set performance goals, conduct evaluations, and identify training and development opportunities for your team.

Provide your team with the tools and development opportunities (including educational assistance, job rotation, cross-functional training, Six Sigma) to make them successful.  

Assessing workload, identifying gaps or imbalances, and reallocating resources or making hiring decisions to optimize staffing levels and ensure efficient operations. 

Foster a feedback culture within the team or organization, encouraging open and honest communication. 

Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups.

Required Education, Experience and Skills:

Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.

Proven supervisory and leadership abilities/formal people management experience. Managed ideally a large team, including mentoring, development, and performance management. 

Possess a deep understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing.

Business Fluent oral / written communication skills in English (C1), and German (B1)

DCS & automated manufacturing process knowledge and experience

Extensive project management knowledge with relevant certifications.

Experience in Quality Change Management Systems and regulatory inspections.

Experience with Cross-Functional Investigations and Root Cause Analysis Techniques.  

Preferred Experience and Skills:

MES (Manufacturing Execution System) knowledge and experience

Experience with continuous processing, including perfusion and/or multi-column chromatography (BioSMB, PCC or similar) 

THE COMPANY 

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community

around us.  

Our Schachen site is crucial for the development and supply of innovative medicines. With over 400 employees, we focus on producing and testing new biological medicines. From Schachen, we export new drugs for global clinical trials, ensuring their safety and efficacy. Additionally, our site investigates suspected cases of drug counterfeiting, operating as one of only three such laboratories worldwide.

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.

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:

02/8/2025

*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:R331742