This is an Associate Specialist position within the Downstream Operations group at our company in the greater Lucerne area. This 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 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.
Project title Associate Specialist Downstream Operations m/w
Job details
Type of employment: Payroll
Skills: DSP, Process Engine
Project start: 01.08.20
Responsibilities
Set up, practical execution and troubleshooting of downstream processes under Good Manufacturing Practices (GMP).
Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility.
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.
Participation in sampling activities (including occasional weekend work) or on‑call duties, as required by the process scheduling. Typical manufacturing activities do not include shift work.
Qualifications
Educational background in a relevant discipline.
A minimum of 1‑2 years of work experience in the pharmaceutical or biotech industry.
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 and assume responsibility. Flexible attitude when working with internal or external stakeholders to achieve ambitious targets.
Business fluent in English and German (effective oral / written communication skills in German C1; oral / written communication skills in English B2+).
Residence within approximately 30 minutes commuting distance from Schachen (LU) or willingness to relocate.
Driver’s license (B) and access to a personal car to enable on‑call duties.
Preferred experience
A bachelor’s or master’s degree in a relevant discipline.
Prior experience in the manufacturing of biologics under GMP, ideally including experience operating capturing and polishing chromatography, virus filtration, UFDF, formulation, fill & freeze.
Familiarity with the use of automated systems in manufacturing (DeltaV) and electronic batch records.
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Project title Associate Specialist Downstream Operations m/w
Job details
Type of employment: Payroll
Skills: DSP, Process Engine
Project start: 01.08.20
Responsibilities
Set up, practical execution and troubleshooting of downstream processes under Good Manufacturing Practices (GMP).
Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility.
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.
Participation in sampling activities (including occasional weekend work) or on‑call duties, as required by the process scheduling. Typical manufacturing activities do not include shift work.
Qualifications
Educational background in a relevant discipline.
A minimum of 1‑2 years of work experience in the pharmaceutical or biotech industry.
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 and assume responsibility. Flexible attitude when working with internal or external stakeholders to achieve ambitious targets.
Business fluent in English and German (effective oral / written communication skills in German C1; oral / written communication skills in English B2+).
Residence within approximately 30 minutes commuting distance from Schachen (LU) or willingness to relocate.
Driver’s license (B) and access to a personal car to enable on‑call duties.
Preferred experience
A bachelor’s or master’s degree in a relevant discipline.
Prior experience in the manufacturing of biologics under GMP, ideally including experience operating capturing and polishing chromatography, virus filtration, UFDF, formulation, fill & freeze.
Familiarity with the use of automated systems in manufacturing (DeltaV) and electronic batch records.
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