You will optimize biotechnological processes and ensure GMP compliance while collaborating with various teams and training future operators in a regulated manufacturing environment.
Anforderungen
- •University degree in biotechnology
- •Several years of experience in CHO cell cultivation
- •Experience with 500 L fed-batch production
- •GMP experience is an advantage
- •Fast comprehension
- •Self-reliant and shows initiative
- •High degree of reliability and responsibility
- •Hands-on mentality
- •Very good spoken and written German and English
- •Microsoft Office applications skills
Deine Aufgaben
- •Perform upstream processing steps in the Test&Training center.
- •Manage cell bank generation and cell culture expansion.
- •Conduct fermentation processes (fed-batch and perfusion).
- •Execute harvesting procedures effectively.
- •Oversee procurement, installation, and qualification of bioprocess equipment.
- •Ensure compliance with GMP guidelines during validation.
- •Collaborate with project teams and various departments.
- •Coordinate with external companies and vendors.
- •Establish and maintain a regulated GMP manufacturing environment.
- •Write and review SOPs and Master Batch Records.
- •Manage procurement of long-lead manufacturing consumables.
- •Prepare and review qualification and validation documentation.
- •Process deviations and changes when necessary.
- •Train future operators for GMP production.
- •Develop and implement a training concept.
- •Optimize biotechnological process steps in upstream areas.
- •Enhance production flow efficiency.
- •Communicate regularly with the Japanese collaboration team.
Deine Vorteile
Opportunity to make a difference
Culture of mutual respect
Commitment to inclusion and diversity
Opportunity for personal growth
Encouragement of bold thinking
Platform to contribute ideas
Original Beschreibung
## Passion for Innovation. Compassion for Patients.
We are seeking a highly qualified candidate to fill the position:
**Bioprocess Specialist (m/f/d) USP**
**Purpose of the function**
As a Bioprocess Specialist USP you will be responsible for the upstream processes and equipment of the new BioDS building and contribute to Daiichi Sankyos future ADC portfolio. You will work in a young, dynamic team on the implementation of new production processes for monoclonal antibodies and their analysis in our newly established process development laboratory (Test&Training Center). You will support the process transfer from the Test&Training Center to the GMP production from Daiichi Sankyo in our new BioDS building, which is currently in construction.
**Roles & Responsibilities**
* You will perform upstream processing steps in our Test&Trainingscenter (working cell bank generation, cell culture expansion, fermentation (fed-batch and perfusion), harvesting)
* You will be involved in the correct procurement, installation, qualification and validation of bioprocess equipment for BioDS according to GMP guidelines
* You will be involved in the collaboration with the project team and different departments (e.g. quality management, engineering, procurement) and with different external companies (e.g. general planning company, sub-companies and vendors)
* You will contribute to establish a regulated manufacturing GMP environment and contribute to its maintenance (e.g. writing and review/approval of SOPs, Master Batch Records and process equipment recipes, hygienic concept; Management and procurement of long-lead manufacturing consumables)
* You will contribute to the preparation and review of qualification and validation documentation as well as the processing of deviations and changes
* You will be responsible for the training of future operators for the GMP production including the implementation of a training concept.
* You will be responsible for the independent establishment and optimization of biotechnological process steps in the upstream area as well as for the optimization of production flows.
* You will be involved in regular reporting to and communication with Japanese collaboration team.
**Professional experience & Education**
* University degree in biotechnology or comparable
* Sound knowledge and several years of experience in the cultivation and fermentation of CHO cells as well as the handling of single-use systems (ideally in a biopharmaceutical company)
* Experience with production scales of 500 L fed-batch or higher
* GMP experience is an advantage
**Personal skills**
* You have a fast comprehension
* You are self-reliant and show initiative
* You work carefully with a high degree of reliability and sense of responsibility
* Hands-on mentality
* Required language skills: German and English (very good spoken and written skills)
* IT skills: Microsoft Office applications