Lead Technician

Vor 6 Tagen

Bern, Schweiz Johnson & Johnson Vollzeit

**Lead Technician GMP Operations**

Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 265 operating companies in more than 60 countries employing approximately 140,000 people.

Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide. The Bern site, with its approx. 600 people of over 25 nationalities, acts as a center of expertise for development and manufacturing of innovative cell based viral
- and bacterial vaccines and bacterial based therapeutic products.

**Main Responsibilities**
- Execution of the practical downstream project work within a cGMP regulated environment. An implicit lead function in process planning and execution can be assigned to a Lead Technician
- Accurate reporting and interpretation of batch manufacturing results. Conclude on results in consultation with the process engineer or the scientist/team leader contributing to campaign reporting and to process and operational improvement
- Carry out development and manufacturing activities according to predefined study plans or batch records complying to the defined timelines
- Carry out core DSP processes (filtration, chromatography, cross flow filtration, centrifugation, buffer preparation, filling, equipment cleaning/setup/prep, etc.) complying to cGMP regulations
- Support and help troubleshoot purification operations
- Support process/cleaning qualification and validation work
- Establishment and ownership of SOPs and manufacturing protocols
- Support safety and environmental initiatives by testing equipment prior to starting production
- Report EHS gaps and/or incidents and initiate EHS improvements
- Document the executed work in protocols and batch records in accordance to good documentation practice
- Perform batch record review
- Plan the execution of work packages and manufacturing operations as well as side activities

Perform manufacturing raw materials/consumables reservations in ERP system

**Qualifications**:
**Who we are looking for**
- MSc or BSc degree in life science (pharmaceutical technology/biotechnology, food technology, chemical technology or equivalent) or technician in life science (pharmaceutical technology/biotechnology, food technology, chemical technology or equivalent) with several years of relevant professional experience
- Flexible, adaptive and a team player
- Ability to work independently and self-disciplined to meet the given timelines
- Very good communication in English, German is a major plus

Previous experience or knowledge with downstream pharma processing operations is a major plus (chromatography, filtration, TFF, etc.)

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