DSP Manufacturing Technician (Level 1)
Key Responsibilities and Work assignments
- Build, clean and sterilise equipment and prepare sterile reagents in compliance with appropriate MIR’s, SOP’s and Work Instructions, completing log books as appropriate.
- Aseptically generate monoclonal antibodies and recombinant protein products by operating column chromatography and continuous filtration (TFF, UF, DF, MF, etc.) equipment.
- Support the maintenance of a compliant facility by, for example, WFI and environmental monitoring sampling and responding appropriately to FMS alarms.
- Proactively highlight to Team Leader any issues of concern, whether they be plant, process, people or performance.
- Take part in Qualification and Validation activities e.g. FAT/SAT, IQ, OQ, PQ and PV as required to support adherence to manufacturing strategy milestones.
- Read, understand and work in accordance with operating documents i.e. SOP's BMRs, Validation Reports, Training Packages, Material Requirement Specifications and other cGMP documentation.
- Proactively contribute to maintaining the DSP suite in a state of Inspection readiness at all times.
- Contribute to investigations (e.g. UE's) as required, to help identify root cause and appropriate corrective actions.
- Contribute as required to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interactions with regulatory agencies.
- Continually identify process improvement and waste elimination opportunities to help create and maintain a lean, flexible and agile manufacturing facility.
- Responsible for own Continuous Professional Development and to proactively share knowledge for the benefit of others.
Competencies required to fulfill the employee responsibilities and work assignments:
An employee shall follow the job description that pertains to his/her position. In addition an employee shall follow the SOPs that pertains to his/her position.An employee shall adhere to the company etiquette in all matters of behavior and manners. The employee shall take the initiative when solving a task assigned to him/her and do whatever is necessary to solve it.It is important that an employee has the company values at heart in his/her work.An employee shall be actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to him/her.
- BSc in Biotechnology, Chemistry, Bio/Chemical Engineering or comparable.
- Scientific theoretical with basic manufacturing knowledge of running downstream purification studies, process validation, and process characterisation of monoclonal antibody and recombinant protein therapeutic products including downstream processing equipment e.g., continuous filtrations (TFF, UF, DF, MF, etc.) and column chromatography.
- Theoretical knowledge of scale-up, technology transfer and process validation activities.
- Open to new graduates in appropriate disciplines although some work experience of biopharmaceuticals preferred.
- Able to give examples of collaborative team-working.
- Knowledge of the role of international regulatory agencies (e.g. the FDA and EMA) with regard to the licensing of biological therapeutic products.
- Awareness of cGMP and cGXP.
- Alvotech is a multinational workplace with employees from all over the world, benefitting from the diversity and the great talent that all of the employees bring into their work.
- Alvotech is a dynamic company that is expanding and growing at a fast pace which involves a lot of growth opportunities for employees within the company.
- Alvotech‘s working environment is friendly and full of energy, employees maintain their good energy by enjoying gourmet bistro at lunchtime; a professional coffee bar and a fully equipped gym with classes thaught daily.
- Alvotech has an active social life that is highly appreciated by the employees, managed by a group of employees that plan all kinds of fun events.
- Alvotech is committed to being at the cutting edge of technology by using some of the best equipment and processes in the industry. With the core mission of improving people´s lives by providing live changing treatments to patients worldwide, the purpose of all Alvotech employee´s work is clear.
- Alvotech already has a powerful group of people that are experts in their fields and we are excited to have more great colleagues to join us.
It is requested that the applicant is able to start work at the earliest possible convenience. All applications will be handled as confidential.
The deadline for applications is 14th June 2019 and will be answered once a decision has been made.
For further information regarding the position please send us a email at jobs@alvotech.