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Process Development Scientist, Biologics
2 months ago
- Overseeing process development operations in non-GMP and/or GMP environments.
- Developing and applying advanced and new scientific concepts to advance biologicals process development activities.
- Applying literature searches to create innovative experimental approaches and to optimize processes and communicate information to the PD team.
- Designing, planning, and executing laboratory experiments.
- Defining experimental protocols and writing work instructions and SOPs.
- Reviewing and approving documentation for each study or experiment ensuring data integrity/quality.
- Overseeing and executing complex experiments in non-GMP and/or GMP environments.
- Operating and troubleshooting equipment and supervising process development work.
- Extrapolating data to develop theories and define process improvement strategies.
- Writing scientific progress reports and conducting internal presentations.
- Transferring technology and processes to technical staff.
- Supporting existing manufacturing processes and making modifications to procedures/products as needed.
- Providing in-depth training on equipment and procedures.
- Leading continuous improvement initiatives for laboratory operations.
- Complying with approved safety practices for the laboratory facility.
- Operating manual, electronic, pneumatic, or computerized laboratory process equipment.
- College diploma plus Biotechnology.
- College diploma plus 5 years of relevant experience is preferred.
- Undergraduate degree plus 4 years of relevant experience is preferred.
- Master's degree plus 2 years of relevant experience is preferred.
- PhD degree is preferred.
- Previous experience in industrial biologics fermentation and/or downstream processing process development is preferred.
- Experience in pDNA/mRNA process development work is an asset.
- Experience in cGMP environment is an asset.
- Ability to switch easily from project to project, as well as conduct various tasks.
- Excellent attention to detail.
- Excellent organizational and presentation skills.
- Excellent written and oral communication skills.
- Ability to communicate and interact with professionals and technical specialists in related disciplines.
- Heavy lifting occasionally required (up to 20kg).
- Ability and willingness to work with potent compounds and following all safety precautions and protocols.
