We are seeking a highly skilled Biotechnology Professional to join our team. This role will be responsible for achieving the objectives set by the Team Leader and the DSP / BUFFER manufacturing manager.
Main Responsibilities :
- Prepare, control, and develop processes for the production of recombinant proteins, monoclonal antibodies or similar biological molecules in microorganisms.
- Achieve the required quality standards by ensuring that all processes are properly executed and documented.
- Develop and maintain documentation to ensure traceability and subsequent work of other departments.
- Maintain equipment and facilities in perfect condition following the manuals provided by the company.
- Ensure that new equipment is properly integrated into the BUFFER Scaling and Manufacturing area under the supervision of the Team Leader and the Manufacturing Manager.
- Select and manage buffer types (inorganic or organic) for the correct operation of the process depending on the different levels of pH and conductivity control and its impact on downstream processes.
- Provide technical support in drafting specific technical documentation and SOPs.
- Record and manage any quality indicators associated with a scaling and solution manufacturing process. Participate in the investigation of the same together with the Team Leader.
- Oversee the control and supervision of materials needed to perform daily activities.
- Ensure that necessary material orders are scheduled in the SAP system to meet the manufacturing schedule according to the project and weekly manufacturing plan.
- Execute activities of the Scale-up and Manufacturing department of media preparation and buffers following operating procedures and GMP requirements under the responsibility of the Buffer Team Leader. Ensure proper training of personnel.
- Accurately complete production records to ensure traceability of production operations.
- Participate in internal / external audits as required by the Quality Assurance Department.
Required Skills and Qualifications :
Advanced Vocational Training or equivalent in related areas (Biology, Biochemistry, Biotechnology, Chemistry, Health, Clinical Laboratory, etc.).University Degree or equivalent in related areas (Biology; Biochemistry; IPPA; Chemistry; Biotechnology, etc.).Master's Degree related to the area (Biology; Biochemistry; IPPA; Chemistry; Biotechnology, etc.) is valued but not necessary.What We Offer :
Between 2 and 3 years of experience in / with : GMP / GLP regulations, Instrumental analysis techniques, Writing of Standard Operating Procedures (SOPs).Intermediate level of English (Level B2 / First Certificate).A dynamic and supportive work environment.Opportunities for professional growth and development.A competitive salary package.Additional Information :
This position requires strong communication and interpersonal skills, as well as the ability to work effectively in a team environment.The ideal candidate will have a strong background in biotechnology and a proven track record of success in a similar role.