Specialist Upstream Operations (m/f/d)

Job Description

Our Schachen serves as a magnetic force that attracts, recognizes, and integrates people from diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but that the site belongs to and is shaped by them.

Our Schachen Biotech is a premier, state-of-the-art facility that integrates advanced technologies into the early-stage clinical pipeline, refining them for future commercial launch. The site supports biologics drug substance manufacturing for early-phase clinical supply and serves as a hub for technology innovation and strategic advancement.

The Specialist Upstream Operations position requires full-time physical presence at the site to support manufacturing and to enable optimal integration into an existing team.

As a member of the growing manufacturing team at our company, you will be responsible for supporting various activities related to the implementation and GMP manufacturing of early-phase clinical therapies.

Responsibilities:

• Set up, practical execution and troubleshooting of upstream operations in fed-batch processes under Good Manufacturing Practices (GMP)

• Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility

• Management and documentation of process execution, deviations, changes and CAPAs. Partnering with Quality Assurance and other internal stakeholders during investigations and technical discussions

• Involvement in continuous improvement efforts and support for the implementation of new technologies, including non-GMP engineering runs or testing activities

• Creation and updates of SOPs and (electronic) master batch records. Technical review of various documentation related to process transfer and GMP manufacturing

• Material management using ERP systems (SAP)

• Mentoring and training of junior team members, active participation in knowledge transfer

• Participation in sampling activities or on-call duties, which may include weekend work

Your Profile:

• Educational background in a relevant discipline

• A minimum of 2-5 years of work experience in the pharmaceutical or biotech industry

• A minimum of 2 years of practical experience in the manufacturing of biologics under GMP, either in upstream or downstream processing

• Expert knowledge of some unit operations in upstream processing of biologics. Prior experience with continuous manufacturing is strongly preferred

• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. Ability to perform under pressure in a complex GMP environment.

• Business Fluent in English and German: Effective oral / written communication skills in English (C1). Oral / written communication skills in German (B2)

• Preferred Experience and Skills:

• A bachelor’s or master’s degree in a relevant discipline

• Experience with quality management and compliance systems (SAP QM/VeevaVault). Experience with deviation management and development of CAPAs

• Familiarity with the use of automated systems in manufacturing (DeltaV) and electronic batch records (PAS-X)

• Ability to work efficiently as part of a team, as well as willingness to take responsibility for independent projects

Our Company is a leading biopharmaceutical company employing over 1,000 people in Switzerland at three sites. The company’s headquarters are in Lucerne. At the site in Zurich, the company operates a global innovation and development hub. In addition, we manufacture medicines for global clinical trials and operate a forensic laboratory in Schachen (Canton Lucerne). We conduct around 40 clinical trials annually in Switzerland. The main therapeutic areas include oncology, infectious diseases, cardiovascular and cardiometabolic diseases. We also have a broad portfolio of vaccines for the prevention of diseases in children, adolescents, and adults and we are one of the leading companies in veterinary medicine. Furthermore, we take our responsibility to the local community seriously and have been involved for many years in initiatives such as the «Trendtage Gesundheit Luzern» and the «Alliance Health Competence».

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 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:

Preferred Skills:

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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.

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