An exciting and challenging opportunity has become available at the Takeda Neuchâtel Plant (approx. 620 employees) for a highly skilled analytical supervisor with validated experience in method transfer/method qualification for recombinant protein.
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the manufacturing science team within a world-class Biotech manufacturing environment.
An exciting and challenging opportunity has become available at the Takeda Neuchâtel Plant (approx. 620 employees) for a highly skilled analytical supervisor with validated experience in method transfer/method qualification for recombinant protein.
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the manufacturing science team within a world-class Biotech manufacturing environment.
Job summary:
Manufacturing Science is owner of the process hence this team of SME’s (Subject Matter Experts) is a key player for all complex issues or projects involving the product. In the scope of the manufacturing science lab transformation a new analytical department will be created to support development projects, lifecycle projects and troubleshooting. The jobholder will have the following responsibilities:
During the project phase the jobholder will manage the transfer of analytical method from Austria to Neuchatel. In addition, create SOPs, logbooks and all analytical documents needed to maintain high quality standard.
During routine phase the jobholder will manage the analytical team and the daily testing of samples generated by the lab process team (cell culture and purification). She/he will be Responsible for planning, maintenance follow up, annual method qualification and all activities related to analytical lab.
Essential Duties and Responsibilities:
- Manage the Manufacturing Science analytical team (2 engineers / 2 technicians)
- Method transfer from QC to Neuchatel MS lab
- Method qualification
- Installation and qualification of the lab equipment’s
- Manage planning (testing, maintenance, annual requalification) and control/reagent stock
- Collects, summarizes, and analyzes data to prepare reports and presentations, as appropriate.
- Write and execute protocols to support process deviation
- Presents the data to a scientific audience (R&D and Manufacturing science partners)
- Lead investigation
- Evaluates and implements innovations in the area of expertise to deliver better performing solutions.
- Perform routine testing as needed
- Project managment
- Perform other duties as assigned
Education & Experience:
- phD or Master in biochemistry, biotechnology or equivalent
- Minimum 8 years of experience in pharmaceutical industry, ideally in QC
- Strong knowledge of recombinant protein analytical methods (Activity, ELISA, SDS…)
- Strong knowledges in method qualification
- Strong experience in analytical method transfer
- Good knowledge of quality system (trackwise, LIMS)
- Analytical and problem-solving skills
- Good statistical knowledges, green belt certification is a plus
- Knowledge of GMP rules
- Fluent in French and good level of English (level C1)