Amsterdam |Process Development | Validation |Continuous Improvement | GMP |NPI & Tech Transfer
Your new role
As a Process Engineer for MSAT you will provide process and product expertise for GMP manufacturing, technology transfer, [process validation for Kites engineered autologous T cell therapy products. You will write product impact assessments for deviations and change controls, technical reports and provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements. You will work with Process Development, Manufacturing and Quality teams to implement and scale-out cell therapy processes, support process validation, as well as draft documentation for regulatory filings to advance Kite’s product portfolio. Some of your key responsibilities will be to monitor process performance through data-based trending, leading continuous improvement projects and support initiatives. You will also participate in evaluation of new technology and process automation for introduction into GMP manufacturing. You will support regulatory inspections and projects for regulatory commitments and support tech transfer and NPI. A key responsibility for this position is the understanding of process development, validation, and lifecycle management to support comparability studies, process validation and licensure changes.
What you'll need to succeed
You have a degree in Engineering, Biotechnology, Life Sciences or related discipline with a minimum of 3 years of pharmaceutical manufacturing, technology transfer or process development experience with practical expertise with GMP manufacturing and regulatory regulations and requirements for pharmaceuticals. You have a mastery of scientific and engineering principals and are comfortable in a fast paced company environment and able to adjust workload based upon priorities. You are self-motivated, detail-orientated and willing to accept temporary responsibilities outside of initial job description. Excellent communication and interpersonal skills are required alongside the ability to think critically and demonstrate problem solving skills.
Your new company
Kite, a Gilead company, is dedicated to achieving one of the most ambitious goals of 21st century medicine: curing cancer. This mission is at the heart of everything they do, from early research to product development. Kite has been at the forefront of cancer immunotherapy and today are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago. With an unrelenting drive and a singular focus on cell therapy, our team is executing on our strategy to bring life-saving therapies to patients.
What you'll get in return
Hays Detachering | This is a project that will start with a contract for 12 months through Hays. Extension to stay within the department is highly anticipated. At this position, you will get a competitive salary and your travel expenses are covered.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1045860
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Wetenschap, Research & Development
Competitive Salary + Travel expenses covered
Spreek met een consultant
Spreek met Tom Murphy, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam