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Termelési biokémikus konjugáció
Biochemist – Conjugation is responsible to complete all assigned work in production antibody proteins.
The Biochemist will provide training to associates on all department technical and business procedures. Review and maintain departmental data and update batch records/SOPs/WI.
The Biochemist will be expected to be able to identify potential problems, provide solutions and work independently to resolve issues with support of supervisors.
Primary Responsibilities and Duties
- Proficiency in all department related processes, with the emphasis on processes that are listed but not limited to:
- Review and scheduling of production work and assignments bulk production and in-process tests.
- Provides technical and hands on support for the product manufacturing.
- Capable to determine pooling fractions, review batch records and perform in-process inspections.
- Executes assigned projects and communicates project status.
- Provides in-process testing as required.
- Maintains detailed production records.
- Assures that material movement transactions are executed in SAP system
- Performs cleaning, inspection, verification for calibration and maintenance of equipment.
- Completes all relevant transactions on SAP system and performs the required inventory.
- Promotes a safe work environment. Follow safety procedures. Participates in Environment Health and Safety programs. Active participant in the Continuous Improvement activities established in the plant
- Executes assigned projects and communicates project status.
Requirements (Knowledge, Skills, and Abilities)
- A combination of minimum one years of working experience (academic or industry) with the following:
- General laboratory practices
- Handling small scale quantities of chemicals and buffer solutions
- Solid technique in pipetting, mixing and application of equipment e.g. analytical scale, spectrophotometer, centrifuge, peristaltic pump
- Experience in preparative gel chromatography, gel electrophoresis
- Documenting in batch record
- Data record or archiving in system e.g. SAP
- Experience and understanding of basic protein biochemistry methods
- Requires a Bachelor Degree in a related scientific discipline (such as Bioengineering, Chemistry or equivalent)
- Experience in a pharmaceutical/ medical device / biotechnology industry or equivalent combination of related education
- Bilingual (English and Hungarian)
As directed by the QC Operation Supervisor, the Biochemist: Responsible for conducting quality analysis of bulk, in-process and finished goods under limited or no supervision following standard operating procedures. The Biochemist should demonstrate proficiency in applicable QC techniques, operation of relevant equipment and software packages associated with testing, data analysis, interpretation and reporting. QC Biochemist is able to perform troubleshooting, investigations, provide and follow corrective/preventive actions for failures and non-conformances.
Primary Responsibilities and Duties:
- Perform all assigned QC tests following analytical methods and procedures (qualitative and quantitative analysis of raw materials and bulk, in-process or finished goods) following analytical methods and procedures (such as Flow Cytometry or ELISA, WB (Western Blot) etc.) for products. This may require working with human blood, human or mammalian cell culture and/or animals and animal tissues.
- Assures bulks and/or finished products conform to established specifications.
- Reviews data on all QC testing as assigned. Performs investigation for atypical or Out of Specification (OOS) results and makes recommendations as appropriate.
- Provides technical guidance to resolve issues and follow-up on actions.
- Supports complaint investigations and report results.
- Performs material transactions in SAP system.
- Attending shift start up meetings and providing appropriate status follow-up
- Ensures that cleaning, maintenance and calibration of QC equipment take place according to schedule.
- Ensures the required docs/records are available.
Assists in the development and evaluation of new procedures and techniques and analyzes existing methods to suggest improvements. Performs Engineering Change Orders (ECO's) as needed. Assists the Supervisor in the preparation / review policies/procedures
Provide recommendations to continuously improve product/process quality and enhance productivity, reduce cost, and increase production capability.
Training & Compliance:
Participates in assigned cross-training or off-site training as required. When experienced, helps new biochemists in area-specific trainings.
Maintains working knowledge of current industry and international standards. Keeps abreast of the US and non-US regulations affecting own area of supervision/management and complies with those regulations. May propose changes to BD practices and procedures to support compliance requirements. Communicates the need for compliance to member of own functional area. Brings regulatory compliance questions/issues to the attention of the next level of management.
Assures finished products conform to internal and government standards and satisfies ISO regulations.
Promotes a safe work environment. Keeps abreast of the basic requirements for safety compliance in own area of work and complies with those requirements. Thoroughly understands lab safety and hazardous waste management. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental, Health & Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor and Safety Officer(s) of all observed hazardous conditions or unsafe work practices.
May perform other related duties and assignments as required
Required knowledge and skills
- Bachelor or Master of Science degree in biology, biochemistry, chemistry, or other related degree
- 0-1 year of relevant laboratory experience in the pharma/biotech/academic research
- Knowledge of immunoassays related to cell biology applications: Cells immunophenotyping, ELISA and/or Western Blots
- Fully Bilingual (English and Hungarian, written and spoken)
- Motivation and proactive thinking
- Detail-oriented with strong written and verbal communication skills
- Contributing effectively to the accomplishment of team and work centers goals, objectives and activities.
- Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work
- Experience with pipetting (single- and multi-channel) in a small volume scale
- Experienced with Microsoft Applications: Excel, Word, PowerPoint
- Aware of general laboratory safety, biosafety procedures and standards
- Good time management, and ability to work independently
- Must have the ability to multi-task in a fast-paced environment
- Proficiency in at least one applicable QC techniques and software packages associated with testing, data analysis, interpretation and reporting with good understanding of the operation of related instrumentation such as Flow Cytometers, Gel Electrophoresis Systems, Optical readers
- Knowledge of cell culturing methods