Job Detail

Senior Specialist, Label Operations - Global Clinical Supplies (m/f/d)

Inseriert am: 30.01.2021
JOB DESCRIPTION

Job Description


We are recruiting for an exciting opportunity for a Senior Specialist, Label Operations -Global Clinical Supplies, based in Schachen (Lucerne), Switzerland. 


Reporting into the Label Operations Manager Planning and Scheduling, the Label Operations Senior Specialist will be primarily responsible for the efficient coordination of packaging projects for clinical supplies executed by our company or through an external contract manufacturer (CMO) within the Label Operations Group. In this highly interdisciplinary role, the Label Operations Senior Specialist will provide support on assigned projects from setup, coordination/ monitoring of all activities for the assigned projects until completion across the different work centres of the supply chain (label translations/ label design/ printing, packaging and quality control). 


Role responsibilities include but are not limited to: 



  • Provide input and partner with other work centres to develop the packaging/labelling strategy for the individual clinical products 

  • Monitor the adherence to project schedules and documents progress in respective databases

  • Ensure project timelines are met in all the work centres 

  • Assist work centres (Global Project Management, Packaging, Operations Planning, Quality disposition group) for issue resolution as needed 

  • Collaborate with global master planning and project management (demand and supply project managers) to establish priorities across different projects 

  • Supports the Label Translation team in label translation task and is responsible that the timelines are met 

  • Negotiate and coordinate timelines with contract manufacturers and requests/reviews quotes 

  • Work out proposals for continuous optimization of processes and procedures (SOPs) concerning clinical supply planning and label operations 

  • Main contact for our company’s Clinical Supplies Project Manager, Operations Planner and the label contract manufacturer 

  • Investigate and write complaints in the event of deviations in Label Operation 

  • Responsible for label room equipment; coordinate and perform qualification of equipment  

  • Responsible for productions statistics and tracking of cost savings 

  • Act as a local SME in Label Operations

  • Responsible for training of contractors 


Good Manufacturing Practices and Compliance in general: 



  • Develop, implement, and continuously improve processes and associated SOPs based on International Regulatory Standards and company Quality Guidelines 

  • Follow workflows and procedures according to current SOPs 

  • Respect our company’s policies concerning safety, health and environmental protection, finance, and quality 

  • Familiarity with GMP requirements, quality procedures, and SOP execution 


Qualifications: 



  • Bachelor’s degree in Life Sciences, Engineering or Supply Chain 

  • At least 5 years of experience in the pharmaceutical industry, preferably in a clinical supply related area (planning, scheduling, coordination, artwork, label translation, validation of equipment of Equipment, process improvement) 

  • Project management skills 

  • Direct work experience with SAP is a plus 

  • Flexible and team-oriented 

  • Diligent and quality-oriented 

  • Structured and proactive working attitude 

  • Proven ability to organize and manage multiple tasks at one time and meet deadlines 

  • English and German (verbal and written) at professional proficiency level are required 


We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. 


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 (Weystrasse, Citybay, Schachen and Kriens). A fifth location has been recently 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. The new location has a target date of 2021 for operational readiness.


Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products 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.


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.


Who we are …


We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.


What we look for …


In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.


INVENT.


IMPACT.


INSPIRE.


Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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. 


Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:


Travel Requirements:

No Travel Required

Flexible Work Arrangements:


Shift:


Valid Driving License:


Hazardous Material(s):


Number of Openings:

1


Requisition ID:R95285

Details