Cimeio Therapeutics is looking for a SVP Cellular Therapy .
Ridgeline Discovery is currently supporting Cimeio Therapeutics, an upcoming, innovative biotech company aiming to drastically change current treatment paradigms in targeted therapies and hematopoietic stem cell transplantation.
This Basel based position offers a tremendous opportunity to support our growing company in an experienced, vibrant, and agile biotech team.
Leading process development and optimization (upstream and downstream) and scale-up activities for recombinant and / or gene edited cell manufacturing esp. for human HSC
Implement gene editing processes in HSCs and T-cells
Ensuring availability of representative material to support pre- / non- clinical studies and CMC development (e.g. material for GLP tox and the clinics, reference material, etc.)
Defining and establishing the Control strategy engineered stem cell manufacturing.
Implementing bioprocess development methodologies, including QbD development concepts and statistical DoE approaches
Managing process Tech Transfer activities from Process Development to Manufacturing
Acting as a subject matter expert to support Manufacturing during manufacturing campaigns (troubleshooting, Change Control / Deviation impact analysis, investigations etc.)
Establishing CMC strategy and capabilities in cell therapy process development
Compiling CMC documentation to support regulatory filings
Participating in vendor selection, management and qualification visits as needed
Supporting supply chain management activities (Starting materials and Drug Substance)
Act as subject matter expert for regulatory and partner / customer inspections
Hire, lead and develop employees to successfully meet group objectives
The role will be based at the Ridgeline offices in Basel, in order to benefit from close interaction with multi-functional team.
At least 4 days-a-week will be on-site and there will be some international travel to attend key industry events, as well to build relationships with COMO partners.
Degree in Biology; Chemistry; Chemical or Bioengineering; BS or MS with 15 years' experience or Ph.D. and 10 years' experience
Direct experience with cell therapy process development
Experience with upstream process development including single use bioreactors, suspension adaptation of adherent cell lines, transfection, and seed train bioprocessing
Experience with large scale close system cell processing equipment is desirable
Familiarity with viral rec. HSC analytical testing and characterization methodologies
Experience with optimizing and scaling up / scaling out manufacturing processes and transferring those processes from to GMP manufacturing
A thorough understanding of quality by design (QbD)
Experience operating in early-stage clinical environments
Strong written and verbal communication skills, including strong presentation skills. Intercultural experience and ability to act in a complex and rapidly changing business environment
Ability to work and thrive in a fast paced, rapidly changing environment
To apply , please send us this application form together with your CV and Cover Letter .