CordenPharma is a leading Contract Development & Manufacturing (CDMO) partner with approximately 2’000 employees across Europe and the United States and annual revenues > 500 M€, enabling pharmaceutical and biotechnology companies to link their requirements for product success with their patients’ healthier lives.
Founded in 1987, CordenPharma Brussels, formerly Peptisyntha, was a member of the Solvay group until being acquired by CordenPharma in October 2013. CordenPharma Brussels has built a 30-year track record of success in supplying pharmaceutical and biotech companies with clinical and commercial scale cGMP peptide APIs.
Through expertise and capabilities in all synthetic peptide-manufacturing technologies, CordenPharma Brussels assesses and customizes its manufacturing approach to achieve the most effective manufacturing process for its customers.
As part of our Process Development & Scale up department, you will build the technical basis for successful execution of peptide manufacturing process development projects.
Duties and responsibilities
- >> 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
Qualifications and skills
- >> 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)
What we offer
We offer a permanent contract, a competitive salary package and varied and motivating responsibilities.
Then we should definitely get to know each other. We look forward to receiving your application via the link or send it to [email protected]