Biotech Process Improvement Specialist Eindhoven

Vacature in het kort

Join our team as a Biotech Process Improvement Specialist and embark on a journey to enhance drug substance manufacturing through product and process improvements. Dive into executing continuous process validation plans, leading technical projects, and troubleshooting processes for clinical and commercial products. Enjoy a unique working environment at TMC, where our Employeneurship model offers stability, profit sharing, personalized coaching, and a strong network. Embrace the opportunity to innovate within our entrepreneurial lab and thrive in a culture that prioritizes collaboration, values, and fun. Continue reading to see why we could be your next step.

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| Summary:

In this position you will become a Biotech Process Improvement Specialist. You will define and drive product and process improvement for drug substance manufacturing.

| YOUR CHALLENGES?

The Biotech Process Improvement Specialist will define and drive product and process improvements for drug substance manufacturing. This will be done by executing the continuous process validation plan for the defined products, and defining product related improvements, or process chemistry related improvements based on the data.

• May lead technical, product/process-related projects of appropriate size and complexity.
• Responsible for second line process trouble shooting for both clinical and commercial products (on the shop floor when needed). Define and follow up when additional above site support is required.
• Supports and reviews facility fit studies
• Support authoring and review of regulatory files to support new product introduction or changes to regulatory files.
• Change owner for complex, multi-departmental or multisite changes. Provides process chemistry impact assessments, and technical assessment
• Write and review continuous process validation reports, including trend data using complex statistical tools and templates.
• Must demonstrate personal commitment with respect to working safely, healthy and environmentally friendly

| WHAT DO WE EXPECT FROM YOU?

• Master/PDeng/PhD in life science, biotechnology, engineering or another technical field preferred
• A minimum of 5 years of relevant experience in biologics or vaccine manufacturing and/or managing biotechnological development projects, gaining experience with project management. Minimum of 2 years of relevant experience if PhD degree is applicable.
• Hands on experience with change management and Lean Six Sigma tools and a high standard for compliance and GMP.
• Broad interest in Biotech (USP/cell culture, DSP/purification, analytical, regulatory, etc.) is preferred; eagerness to learn is a must.
• Excellent English communication skills (verbally and written); Dutch is highly preferred.
• Team player skills

| WHAT DOES OUR BUSINESS CELL HAVE TO OFFER?

Our business cell lives by 3 principles:

1. Best over biggest.
2. Collaboration over individualism.
3. Values and ethics over rules.

| WHAT CAN YOU EXPECT FROM TMC?

TMC is an international high-tech consultancy company that brings expertise to their clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster changing technological world.

At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career.

As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.

| WHY CHOOSE FOR EMPLOYENEURSHIP?

We are truly unique thanks to our Employeneurship model which is a true innovation for the High Technology consulting business. It is the business relationship of the 21th century for high skilled technical professionals. It is built around 5 main pillars:

• You will have a permanent employment contract, offering you stability and security
• You will get to know your market value and have a share in the profit your work generates thanks to the individual profit sharing
• We will support you with a one-on-one coaching and trainings designed to help you develop your entrepreneurial skills
• The competence cells structure, provides you with a strong meaningful and relevant network
• The entrepreneurial lab: a playground for new ideas and a potential launching for start-ups

TMC is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.