Associate Director Analytical Development (NK platform)

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 to further develop our NK cell platform. We are now looking to further strengthen our  US branche with an:

 

Associate Director Analytical Development  (US East Coast).

 

The role
As an Associate Director Analytical Development, you will be responsible for
Leading the development of AD/QC activities in the US for Kiadis. You will be a core team member of the CMC team for NK cell product portfolio. Additionally, you will be responsible for the establishment of the AD/QC capabilities in the US for the broader Kiadis pipeline.

 

Your key tasks & responsibilities will consist of:

  • Management of analytical NK cell activities at CROs / CMOs.  
  • Overseeing development, optimization and validation of analytical methods for release testing and product characterization. 
  • Overseeing analytical review of QC testing for lot disposition and support root-cause investigations into OOS and OOT results. 
  • Establishment of systems for sourcing and managing critical testing reagents 
  • Further development of analytical expertise on NK cells. 
  • Based on the scientific direction from and together with the Research and Immunology team, define product characterization capabilities and strategy 
  • Responsible for establishment and oversight of product stability plans 

     

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. This means leading and overseeing the (outsourced) QC execution for clinical product release, such as product characterization and method investigations for the NK cell program. You will have a pivotal role in defining the method transfer strategy to CROs and CMOs and establish (or optimize) procedures and methods for QC testing and product characterization. Next to confirming the proper implementation and trending of QC methods after validation, you also assure the availability of reports and contribute to quality section of regulatory filings.

 

Location: US-based, East coast, with frequent travel to TX and NC, and up to 15% to Europe
Reports to: Head of Analytical Development


The ideal candidate

We are looking for someone that has experience in the development and validation of biological release methods in the pharmaceutical / biotech industry. You need to be a self-reliant leader with strong problem-solving and communication skills. You have experience with working in a matrix organization and are capable of collaborating with experts from Research, QC, QA and RA.  

  • PhD in biomedical discipline or immunology with 5-10 years of experience, preferably in the field of cell based assays and NK cell biology. Experience in (remotely) coordinating a team of analytical scientists.
  • Proficiency in the development, transfer, and validation of biological methods according to ICH / USP guidelines.
  • Experience with outsourcing of biological methods.
  • Experience in GMP quality procedures.

 

 

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.

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