Manager Downstream Operations
Manager Downstream Operations
CSL Behring is a leading global biotherapeutics company committed to its promise to save lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia.
In May 2014, CSL selected Lengnau in the Canton of Bern in Switzerland as the location of a new manufacturing facility to support the commercial production of our promising novel therapies.
The CSL Behring Recombinant Facility (RCF) in Lengnau is part of CSL's ongoing global expansion strategy to support the company's long-term growth plans.
The new plant in Lengnau will manufacture three recombinant coagulation factors to treat hemophilia A & B patients. For one of these products we have already received marketing approval, for the second product we expect global market launch this year. The Lengnau site project generates an investment of several hundred millions USD and will create around 300 new jobs when it is fully operational in 2019/2020.
Are you interested in being part of this exciting project?
We are looking for an experienced
Manager, Downstream Operations
We are seeking personalities with the desire to contribute actively to the construction of the new production site. This position is responsible for supporting the Director, Drug Substance Manufacturing in leading and managing a Downstream production line in the Lengnau Recombinant Cell Culture Facility.
Main Responsibilities and Accountabilities:
During the Project Phase:
- Works closely with the Project Management Organization to support the design, purchase and commissioning of the production equipment in accordance with process requirements and compliant with applicable cGMP requirements.
- Works closely with the Quality and Engineering organization to support the qualification of the downstream production equipment.
- Participates in Technology Transfer activities to implement the purification production process in the new facility.
- Supports the PPQ execution for the downstream process.
- Is responsible to collaborate with BT, Engineering and Quality to specify, qualify and implement all necessary information systems for the production area within the field of responsibility (MES, Historian, SAP, BMS and others)
Commercial Operations Phase:
- Is responsible for the daily operations of a purification suite at commercial scale capacity.
- Performs manufacturing level maintenance on equipment.
- Analyses samples using simple techniques such as pH, osmolality and conductivity.
- Gathers, trends, and analyses process generated data.
- Participates in defining robust process parameters during routine manufacturing campaigns.
- Works to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns, in close collaboration with the R&D colleagues.
- Keep process area stocked with essential equipment and components.
- Build cross functional teams and interact with other support functions such as Quality Assurance, Quality Control, Manufacturing Engineering, MTS, Validation, and other relevant functional areas.
Qualifications & Experience:
- Bachelor degree required preferably in chemistry, pharmaceutical, biochemistry, technical or related field
- Master degree preferred in life sciences (MSc or equivalent) in a scientific/technical discipline
- Knowledge of ISA 88 standard preferred
- Minimum 3-5 years successful experience in pharmaceuticals or another highly regulated industry in operations functions required
- In depth knowledge of recombinant protein production, blood industry or related field required
- Experience with technology transfer from an R&D organization would be an advantage
- Speak and write proficiently in German and English languages
- 3 - 5 years' experience in a cGMP regulated production environment (pharmaceutical or biotech industry)
- Intermediate to strong working knowledge of Microsoft Office products
- Proven ability to work in a fast paced, dynamic environment
- Learn new processes and quickly engage in assignments to drive for action
- Makes decisions in accordance with established policies and procedures
- The position might require a substantial amount of travel in the initial project phase (up to 50%). This will be substantially diminished after the commissioning phase.
Are you motivated to join us in this exciting journey to establish a state of the art pharma manufacturing facility with most advanced technologies?
Offices will be in Stöckacker, Bern, and later in Lengnau.
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. For initial information you are welcome to contact Recruitment at +41 31 344 12 51.
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