CMC Leader / Director CMC

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 strengthen our cell therapy platform with NK cell technology. We are now looking to further strengthen our organization with a:

CMC Leader  / Director CMC

 

The role

You lead the CMC development of the Kiadis NK program, inclusive of final drug product and proprietary reagents.  You will lead the development of the CMC strategy for the program and drive the execution of the CMC strategy across a team that includes process development, analytical development, regulatory, patient operations and QA. You will have direct management responsibility over technical CMC development staff in the US, as well as accountability for oversight of external clinical supply from CDMO partners during early development.

You form the bridge between CMC team members in the Netherlands and the US, by actively leading and participating in the planning and design of CMC development as well as technology transfer programs. Together with Kiadis functional groups, your identify strategic capabilities needed for the NK program and how to build these capabilities.  While early development CMC and clinical manufacturing activities are outsourced to a CDMO, you will work across the Kiadis Operations team to help develop the long-term sourcing strategy.   As a member of the Product Development Team, you will ensure full alignment of the CMC and manufacturing plans with the clinical development, regulatory and commercial launch plans. 

Your key tasks & responsibilities will consist of:

  • Lead the cross functional CMC development team for the NK program
  • As a people leader, directly manage the US based process development team
  • Define and implement the CMC development strategy for the program and create alignment with functional Kiadis leaders and within the NK Product Development Team
  • Manage external manufacturing activities during early clinical development
  • Align CMC team members and sub-teams across geographic locations on content and strategy and create synergy in activities taking place at multiple sites
  • Ensure timely delivery of (source) documents for regulatory filings
  • Take a leadership role in establishing the Kiadis US based CMC and manufacturing capabilities by setting up the required process development capabilities (raw materials, cell culture, media, process engineering, formulation) and by providing active support to the set-up of other functional roles (regulatory, analytical development, late stage/commercial manufacturing)

This role will be East-Coast based in the United States.


 

The ideal candidate

We are looking for someone that has a proven track record in the industry and has strong management and influencing skills. As a core member of the NK Product Development Teamyou are responsible for creating and managing productive relationships across functions and for creating synergy between teams. Therefore, good communication and organizational skills are a must. Travel for up to 50% of the time may be required for this job. 

Therefore, we are looking for the following elements to be present:

  • PhD in Cell Biology, Biotechnology, Bioprocess Engineering, or related field 
  • Around 12-15 years hands-on industrial experience in biopharmaceutical process development or manufacturing 
  • Experience in leading cross-functional development teams for early and / or late stage CMC development projects 
  • Extensive experience in writing CMC sections for IND and/or BLA, preferably in the field of cell therapy 
  • Experience in managing development and cGMP manufacturing activities at a C(D)MO 
  • Expert in cell culture (ideally in culture of primary cells such as T-cells, NK cells or stem cells) 

 

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 to make 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