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 COO, the Manufacturing and NPI Director owns all 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 all activities surrounding this plan and execution.
The Manufacturing and NPI Director is the product owner. The ownership begins with the design or development freeze and continues throughout the life cycle of the product. The Manufacturing and NPI Director joins the development stage as the voice of the manufacturer and is a critical part in the DFM (Design for Manufacturability) process.
We are looking for a team player with strong leadership and interpersonal skills as well as substantial 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 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
Join the final stages of development as the voice of the manufacturer. Act as the link between R&D to the manufacturing. Understand manufacturing capabilities VS. design requirements, perform DFM and DTC (Design to Cost).
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 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.
Improve Product Quality and robustness. Scale up manufacturing.
Own MeMed’s future pilot plant.
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
- MA or PhD in biotechnology, biochemistry, biology or chemistry. Alternatively, we will consider the application of highly skilled and experienced bachelor degree holder.
- 5-10 years of experience as an NPI director and/or head of manufacturing in an IVD company (preferably immunoassays).
- Highly experienced in establishing and developing manufacturing and QC processes in the IVD industry, including quantification, value assignment, HPLC, purification, chemical reactions, lyophilization.
- Ability to successfully work and develop within a small company start-up environment.
Location & Travel
MeMed headquarters are based in Haifa, Israel. The position involves extensive international traveling.
The position is also open to EU residents, with 1- 2 weeks/month stay in Israel.