Chemical Team Leader
We are working with a client who is a leading Contract Development & Manufacturing (CDMO) partner in Europe and the United States. They enable pharmaceutical and biotechnology companies to link their requirements for product success with their patients’ healthier lives.
As part of their Process Development & Scale up department, they are looking for a Chemical Team leader to build the technical basis for successful execution of peptide manufacturing process development projects.
What you will do:
- Lead peptide manufacturing process development projects from feasibility study over optimization and scale-up until validation, comprising up- and down-stream processing. Conduct the associated laboratory work following PDS technician workload.
- Responsible for R&D technical project-related documentation such as written updates feasibility and development reports.
- Act as technical contact to customers and project manager – participate to internal and external project and related meetings.
- Assure respect of timelines and fulfillment of project objectives. Anticipate deviations from the latter and inform management and project manager.
- Perform evaluation of projects: timely preparation of costs evaluations for customers’ requests.
- Perform some production activities (organize the tech transfer for GMP productions in the frame of development projects. Coordinate project related trouble-shooting. Provide BOM for first GMP production to the Supply Chain. Definition of specifications for specific project-related raw materials. Training of production operator according project specificity).
- Coordinate risk assessments and process validation-related documentation
- Collect data in technical report and provides support for regulatory submissions
- Master degree in Chemistry or equivalent by experience
- Minimum of 5 years of experience of process development in a CMO related activity
- Good knowledge of GMP Guidelines of API
- Experience in CDMO is an asset.
- Ability to work independently in a fast paced multitasking environment.
- Rigorous with excellent organization and coordination skills.
- Strong customer oriented-mindset.
- Flexible, able to set priorities and solution oriented.
- Team spirit and ability to work in an interdisciplinary and international environment.
- Strong oral & written communication skills (English & French).
- Excellent command of Microsoft applications (Word, Excel and PowerPoint)
On this occasion, LiCa Scientific is acting as an employment agency.