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Senior Process Optimization Specialist
2 weeks ago
This role plays a pivotal part in the transfer, validation and troubleshooting of existing clinical and commercial processes. Key focus on technology transfer biologics includes devising and executing process optimization studies to support manufacturing efficiencies and new product introduction activities.
The position provides technical leadership for biologics manufacturing, process validation, and the support of process optimization, including laboratory scale studies.
The role contributes to technical assessments on new products in partnership with global technical teams, providing input to product strategy.
Responsibilities- Contribute significantly to the strategy and business planning processes ensuring cross-functional collaboration and leadership execution.
- Support the execution of the overall Manufacturing strategy aligned with the facility's strategic business plans and global Manufacturing strategy.
- Lead and mentor technology transfer teams from initial project kick-off to commercial manufacturing support.
- Develop PPQ strategies and execute projects onsite.
- Scale-up through technology/process transfer to clinical and commercial manufacturing.
- Apply fundamental engineering principles relevant to bioprocess unit operations for scale-up and technology transfer.
- Plan and execute small-scale validation studies.
- Responsible for manufacturing process validation plans, protocols and reports.
- Design, execute and document experiments to support manufacturing improvements and investigations.
- Participate in the diagnosis and resolution of production challenges which are process related.
- Provide critical process information necessary for maintaining consistent product supply.
- Monitor production and lab processes using statistical tools for trending, analyzing and when appropriate modeling the data.
- Able to apply design of experiments principles to screening and process characterization studies.
- Lead science-based risk assessments to support decision making for Quality and Manufacturing.
- Ensure accurate and complete documentation of scientific experimental plans, data and reports.
- Skilled in applying design of experiments principles to screening and process characterization studies.
- Ability to lead science-based risk assessments to support decision making for Quality and Manufacturing.
- Expertise in process optimization and transfer.
- Proficiency in laboratory scale studies and process validation.
- Strong understanding of biologics manufacturing processes.
This role offers a unique opportunity to contribute to the development and implementation of innovative biologics manufacturing processes.
As a key member of our team, you will have the opportunity to work closely with global technical teams and contribute to the success of our organization.
We offer a dynamic and challenging work environment that fosters growth and development.
