Associate Director Process Development

When it comes to life-threatening 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
, we are looking for a driven:

 

Associate Director Process Development  (US East Coast).

 

The role

As an expert in process development, cell culture and media, you provide scientific and technical leadership over creating robust understanding of NK cell culture and media, and over the process development of robust production processes. You will provide expert input on DoE study designs and help analyze complex (DoE) datasets and will write and review reports of relevant sections of CMC dossiers.  

This role will be a team member of the CMC development team for NK cell products, interfacing with key stakeholders from quality and regulatory. Initially, these activities are focused on managing process development initiatives at selected outsource service providers, CDMOs, research partners, or EU-based Kiadis teams. However, this position may have longer term responsibilities in establishing and leading in house process development capabilities in the US.  

Your key tasks & responsibilities will consist of:

  • Drive development work on the NK cell program across different locations 
  • Develop a scalable platform process for NK cell expansion and proprietary critical reagents with counterparts and stakeholders in EU and US 
  • Manage and coordinate process development activities across multiple internal and external sites, including experimental setup, data analysis and reporting 
  • Apply expert knowledge to help design the CMC strategy and development studies in coordination with US and EU teams and leaders 
  • Align different teams / team members on content and strategy and create synergy in activities taking place at multiple sites 
  • Responsible for generating source documents and CMC sections for regulatory filings  

In this global role you will work together with process development and manufacturing teams on NK cell product development. Additionally, you will partner with CMC, Clinical, and Research partners to define NK cell product-related TPP and CQA plans.

Location: US-based, East coast, with frequent travel to TX and NC, and up to 15% to Europe

The ideal candidate

We are looking for someone that has deep process development experience and is very comfortable in managing process development activities at Contract Development and Contract Manufacturing Organizations (CMO). You need to be a self-reliant leader with strong problem-solving and communication skills. Therefore we would expect you to fit the following profile:

  • PhD in Cell Biology, Biotechnology, Process Engineering, or related field 
  • 8-10 years hands-on industrial experience in biopharmaceutical process development / cell culture development 
  • Experience in representing process development in CMC teams for early and late stage development projects  
  • Deep expertise in cell culture (ideally in culture of primary cells such as T-cells, NK cells or stem cells), cell metabolism, media/feed optimization, perfusion and scale up. 
  • Expert level experience in statistical experimental design (DOE) for process development 
  • Experience in managing teams of scientists and engineers focused on upstream development 


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