#Chemistry NPI Specialist
Who are we looking for?
If you're an outstanding professional from the IVD or Biotech industry, a team player that gets the job done, with a passion for realizing game changing medical products, we would love to hear from you.
We are seeking an exceptional professional to join our operations team. Reporting to the Director of NPA and manufacturing, the NPI associate leads activities at MeMed and contract manufacturers surrounding the transfer of a product from development to manufacturing and the manufacturing process life cycle. This includes developing a plan for the New Product Introduction, tech transfer, QC plan, process change or improvement, managing activities surrounding this plan and execution.
We are looking for a team player with strong interpersonal skills as well as experience in designing and implementing NPI, transfer to manufacturing and improvement projects. A candidate with extensive knowledge and experience in the manufacturing of immunoassays is preferable. The candidate will have a background in NPI and process engineering in the IVD or biotech industry, transfer to manufacturing and project management, as well as a proven experience in process improvement, cost reduction and lean manufacturing methodologies
Primary Job Responsibilities
Work with the R&D team to finalize design documents as preparation for the transfer to manufacturing project.
Lead the cross-functional interactions to define, develop, implement and validate the tech transfer or process change at manufacturer site.
Prepare NPI/Tech transfer project scope and budget, build the BOM and relevant documentation and lead the project.
Work with R&D and contract manufacturers to develop manufacturing processes, QC methods, IQ/OQ/PQ, DMRs, DHRs, stability plans and other documentation
Post NPI, act as main focal point for the product, production process and Contract Manufacturer (CM) related issues.
Build, implement and manage product, quality and efficiency KPIs.
Continuous improvement facilitator – conduct Kaizen and root cause analysis. Conduct failure investigations and manage CAPA
Improve Product Quality and robustness. Scale up manufacturing.
Skills and Competencies
- Excellent communication and interpersonal skills.
- A self-motivated problem solver that "gets the job done".
- Excellent writing and verbal communication skills in English.
- A+ player with a passion for team work.
- Strong track record in establishing NPI Methodologies with then equal enthusiasm to drive the day-to-day execution and get the job done.
Education and Experience
- PhD in biotechnology, biochemistry, biology or chemistry. Alternatively, we will consider the application of highly skilled and experienced bachelor degree holder.
- 2-5 years of experience as an NPI associate in an IVD or biotech company (preferably immunoassays).
- Experienced in establishing and developing manufacturing and QC processes in the IVD or biotech industry, including quantification, value assignment, HPLC, purification, chemical reactions, lyophilization.
- Previous position at a startup – an advantage.
Location & Travel
MeMed headquarters are based in Haifa, Israel.
The position involves extensive international travelling.