(Sr) Technical Operations Engineer

 When it comes to life-threating diseases, we are one family.

We are Kiadis, a biopharmaceutical company who focusses on the treatments of blood cancers aiming to make bone marrow transplantations, safer and more efficient. We are fast-growing and have recently acquired CytoSen in the US. With this transaction we are now a leader in cell-based cancer immunotherapy with complementary T-cell and NK-cell platforms. 

In support of our rapid growth and the expansion of our portfolio into innovative NK cell therapies, and to help set up and qualify our production with our CMO’s on the US East coast, we need a driven:

(Sr) Technical Operations Engineer  
 

The role

The Senior Technical Operations Engineer has a leadership role in ensuring the reliability, capacity and quality of Kiadis’ NK cell-based manufacturing processes at our US based Contract Manufacturing Organizations (CMO’s). In this role you manage and optimize existing production processes and technologies, by monitoring and understanding their performance, identifying and leading improvement opportunities. As the primary contact for our CMO’s,  you will be responsible for resolving escalated process deviations or investigations.

In your role, you will:

  • Represent the manufacturing organization during development of new processes. Leads risks assessments, the “fit for manufacturing / process fit to plant” process.  
  • Define and manage manufacturing related change controls, quality events and CAPAs.
  • Be the process lead for review and approval of cGMP documentation.
  • Collaborate with QA and QC to secure release of clinical materials and perform product trending.
  • Manage and improve the processing technology knowledge and acts as subject matter expert to proactively identify new trends and opportunities.
  • Help assess the feasibility of new equipment, processes and changes to established processes or equipment and lead the implementation.
  • Select raw material suppliers and perform impact assessments of vendor changes (in collaboration with our partners).
  • Provide hands-on technical support and guidance to departments/staff at manufacturing sites regarding related issues plus supporting production staff in case of urgent issues (Hotline)

 

The department

The Technical Operations department supports the Process Development team by providing manufacturability guidance and monitors validated processes as part of Continuous Process Verification. It executes technology transfers of the existing cell production processes across our manufacturing sites in the US and EU . The department also provides technical support to external manufacturing units in order to resolve process deviations, investigations and change controls.

The ideal Candidate
We are looking for someone that has a strong understanding of state-of-the-art practice in biologics or cell therapy field. You need to have a strong sense of quality and be of a very pragmatic nature. As you will be in person support (PIP) for outsourced manufacturing, the position requires travel to CMOs/contractors.

Your profile:

  • BSc. Or MSc. In Biotechnology, Process technology or a related field
  • 5-10 years of relevant working experience in positions with pharmaceutical manufacturing under GMP; At a minimum with biologics products and preferably cell therapy products.
  • Strategic forward-thinking manner, with the ability to communicate to people at all levels of an organization
  • Organized, bring focus and structure into projects.
  • Self-directed with a strong operational focus 


What we offer

A challenging position in an innovative, fast growing, biotechnology company. Working in a fast-paced dynamic environment brings the opportunity to make your own mark within the organization. You will be rewarded a competitive remuneration package, the opportunity for personal development and to contribute in making a huge difference for patients.

If you're interested in the position or would like to hear more, please leave your details and apply via the application button.

 

Kiadis Pharma is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Talent Acquisition Department. We kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Talent Acquisition Department and the recruiting agency will not create any implied obligation.

 

About Kiadis Pharma


Kiadis Pharma is a clinical stage biopharmaceutical company developing innovative products to make bone marrow transplantations safer and more effective for patients. Kiadis Pharma believes that its innovative products have the potential to address the current risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), thereby meeting a significant unmet medical need with its products.

More about Kiadis Pharma

Contact information

Kiadis Pharma
Paasheuvelweg 25A
1105 BP Amsterdam
The Netherlands

+31 (0)20 240 52 50
+31 (0)20 240 52 51
recruitment@kiadis.com