The scientist position is responsible for immunological and physicochemical method development, validation and transfer of methods used for biological products characterization. Responsible for the development and validation of analytical procedures used to analyse drug substances and drug products as well as the transfer of these procedures to the various sites. Responsible for re-evaluating, optimising and troubleshooting methods as required by clients. Also, responsible for performing analytical testing and analysis of biological drug substance and drug products.
- Work under the direction of lab management or other higher-level scientific personnel to develop, validate and apply novel methodologies/approaches pertaining specifically to physicochemical and immunogenicity assays, contributes scientifically to method development.
- Execution of ELISAs, cell-based assays, and other immuno based assays.
- Execution of HPLC based assay, and other physicochemical assays.
- Learn and perform required laboratory techniques using novel and established protocols and Standard Operation Procedures.
- Production of quality data and documentation in adherence to timelines and maintenance of GMP functions in the lab.
- Responsible for maintenance of accurate documentation of all project work in appropriate laboratory notebooks according to internal procedure.
- Maintain method development documentation in accordance with departmental procedures.
- Communicate with clients regarding progress on scientific and operational objectives.
- Prepare and present project data and supporting information. Contribute to and review technical reports.
- Work with team members to manage assigned projects to establish priorities, set schedules, and monitor progress to ensure that projects are progressing satisfactorily.
- Instruct/assist other scientific employees as needed, in the proper sample preparation and method development.
- Perform sample accessioning/handling according to SOP.
- Assist with troubleshooting laboratory instrumentation and other maintenance as required.
- Production of Standard Operating Procedure or modifications of existing processes.
- Ability to work a flexible schedule and adapt efficiently to program changes.
- Maintain personal training file and assist in training of other technical staff.
- Uphold all safety standards, discipline guidelines and regulatory compliance requirements.
Required Education, Skills and Abilities
- Education: MSc
- Experience: 5+ years with demonstrated ability to complete more complex role/duties
- Thorough understanding of and experience with a broad array of immunoassay and physicochemical techniques, instrumentation, development/validation of methodology, sample handling and preparation, interpreting of data, interacting with clients, and adherence to objectives/timelines are integral to this position.
- Technical knowledge in key areas sufficient to enable novel assay development and/or troubleshooting for physicochemical immunogenicity assays.
- Ability to maintain clear and efficient method development documentation
- Ability to follow scientific directions and work in a team
- Ability to complete documentation per GMP (Good Manufacturing Practices) requirements
- Ability to adhere to SOPs (Standard Operating Procedures)
- Ability to follow verbally communicated or draft procedures
- Highly experienced in all routine laboratory procedures
- Understanding of development/validation of methodology
- Ability to interact appropriately with clients, and work to objectives/timelines
- Excellent attention to detail and communication skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Must be proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook).
- Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
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