Caring for the world one person ata time inspiresand unites the people of Johnson & Johnson. This culture of caring is thefocus of our corporate philosophy, that is anchored in the internationallyapplicable Credo.
We embrace research and science - bringing innovative ideas, products andservices to advance the health and well-being of people.
Employees of theJohnson & Johnson Family of Companies work with partners in health care totouch the lives of over a billion people every day, throughout the world.
Wehave more than 260 operating companies in more than 60 countries employingapproximately 134,000 people. Our worldwide headquarters is in New Brunswick,New Jersey, USA.
Janssen Vaccines in Bern(Switzerland) belongs to the Janssen Pharmaceutical Companies of Johnson &Johnson. Janssen is an organization of over 30,000 professionals workingpassionately to prevent, treat, cure and stop some of the most devastating andcomplex diseases of our time.
In Bern, about 300 people of over 20nationalities work together with the wider Janssen organization and partners onthe development, manufacturing and analytical testing of novel vaccines andbacteria-based pharmaceutical products.
We are committed to bring meaningfulinnovation to global health by combating major threats to the health of peopleworldwide.
For our site inBern we are looking for a highly committed
LeadTechnician DS Operations
Aim of the position :
Process development, scale up and manufacturing at pilot scale ofdrug substance material complying with cGMP regulations within the downstreamprocessing group (DSP) of the drug substance (DS) operations department.
Planning and carrying out of the practical work; Continuous processimprovement; Reporting and managing of quality issues and CAPAs;
Batchdocumentation review; Generation and update of manufacturing andprocess / equipment relevant documentation.
Main responsibilities :
Execution of the practical downstream project work withina cGMP regulated environment. To a lead technician an implicit lead function inprocess planning and execution can be assigned.
Accurate reporting and interpretation of batchmanufacturing results. Conclude on results in consultation with the processengineer or the scientist / team leader contributing to campaign reporting and toprocess and operational improvement.
Carry out development and manufacturing activities accordingto 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 validationwork.
Establishment and ownership of SOPs and manufacturing protocols.
Support safety and environmental initiatives bytesting equipment prior to starting production.
Report EHS gaps and / or incidents and initiate EHS improvements.
Document the executed work in protocols and batchrecords in accordance to good documentation practice.
Perform batch record review.
Plan the execution of work packages and manufacturingoperations as well as side activities.
Perform manufacturing raw materials / consumablesreservations in ERP system.
Take part in establishment and provide feedback tostudy plans, study reports, SOPs, MBRs, technical and equipment maintenance / calibrationreports.
Report quality documentation gaps and act upon themdepending on defined responsibilities.
Implementation and introduction of new processing techniquesand manufacturing equipment and / or coordination of equipment improvements andmodifications.
Communication with external parties for purchase ofnew equipment and materials.
Support equipment qualification and computerizedsystem validation activities.
Internal organization of assigned pilot plant facilitysuites including implementation of safety relevant procedures as well ashouse-keeping activities (log books, cleaning protocols, etc.
in accordance tocGMP regulations.
Reporting of non-conformances and initiation ofquality issue records and low impact investigations as well as correctiveactions under cGMP.
Your Profile : Essential
BSc in a life sciences discipline or equivalent (field : pharma / biotechnology, food, chemical or equivalent).
Professional work experience as technician with leading responsibilities or equivalent in the life sciences field in a cGMP environment.
Flexible, adaptive and a team player.
Ability to work independently and self-disciplined to meet the given timelines.
Language skills : good German skills and fluent English spoken and written.
Previous experience with downstream pharma processing operations (chromatography, filtration, TFF, etc.)
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms. Have we piqued your interest?
Please send us your online application (CV, Working References etc.)