
Process Development Professional
3 days ago
Process Development Specialist
Job DescriptionThe Process Development Specialist will be responsible for the development of viral clearance or purification processes. This role involves working with various laboratory equipment and systems to ensure that high-quality products are produced efficiently.
Responsibilities and Deliverables:- Work closely with cross-functional teams to develop and implement process development strategies.
- Develop, operate, and maintain downstream processing equipment including chromatography, filtration, and low pH inactivation systems.
- Perform laboratory tests and experiments to evaluate process performance and optimize yields.
- Maintain accurate and complete documentation of all laboratory activities, including lab notebooks, batch records, and equipment logs.
- Collaborate with analytical and virology teams to ensure seamless integration of post-processing sample transfer.
- Record process parameters, step yields, and relevant observations during execution.
- Transfer processed samples to relevant teams as per predefined timelines.
- Participate in deviation handling, risk assessments, and change control processes.
- Adhere to safety protocols and report any incidents, non-conformances, or atypical events promptly.
- Knowledgeable in appropriate Viral Clearance and GLP guidelines (including ICH Q5A and OECD Guidance).
- Must possess excellent organizational skills, attention to detail, and effective communication skills.
- Must display a high degree of professionalism and confidentiality.
- Master's degree in Life Sciences or other relevant area.
- Minimum 3 years of relevant experience including a minimum of 1 year of related work experience in viral clearance or purification process development.
- 2+ years of experience working in a lab environment under GLP guidelines.
This role offers the opportunity to work in a dynamic and collaborative environment, with access to state-of-the-art equipment and technologies.
OthersIf you have a strong background in process development and are passionate about contributing to the success of our team, we encourage you to apply.
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