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Pfizer
     
 

Sr. Scientist/Associate Director, BioAnalytical Development

 
     
 
Company Catabasis Pharmaceuticals
Location Canbridge, MA
Job Title
Sr. Scientist/Associate Director, BioAnalytical Development
Job ID: JOB-CODE JZ-001
To Apply: Please send your cover letter and resume to careers@catabasis.com.
 

  Company Description  
 
Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB) is a clinical-stage biopharmaceutical company focused on bringing transformative therapies to patients with rare diseases. Our corporate focus is to discover, develop and commercialize transformative therapies for rare diseases. Our SMART (Safely Metabolized And Rationally Targeted) linker drug discovery platform enables us to engineer molecules that simultaneously modulate multiple targets in a disease. We are applying our SMART linker platform to build an internal pipeline of product candidates for rare diseases and plan to pursue partnerships to develop additional product candidates. Our lead program, edasalonexent (CAT-1004), has the potential to disrupt treatment paradigms. Edasalonexent is an oral small molecule NF-kB inhibitor that has the potential to be a disease-modifying therapy for all patients affected with Duchenne muscular dystrophy (DMD), regardless of the underlying mutation. Headquartered in Cambridge, MA, Catabasis is building a team of highly motivated and experienced professionals who are committed to achieving its mission of bringing hope and life-changing therapies to patients.
As Catabasis advances its pipeline through clinical development toward approval and commercialization, we are seeking a Sr. Scientist/Associate Director, BioAnalytical Development to join our small and dynamic organization. The successful candidate will provide hands-on leadership in designing and executing LC-MS/MS based bioanalytical method development, bioanalytical study design and sample analysis for discovery projects, and will be responsible for method transfer, validation and relevant study execution at CROs for development candidates. You are expected to be a collaborative scientific leader with an acute attention to detail, motivated by the opportunity to positively impact an exciting pipeline within the company and the quality of patient lives.
 
   
  Key responsibilities:  
 
  • Develop LC-MS/MS based bioanalytical methods, to support in-house discovery programs and regulated bioanalysis of small molecules;
  • Perform accurate and quantitative analysis of drugs and their metabolites in complex biological matrix for PK/PD and biomarker studies;
  • Routinely act as the project leader on multiple projects, interact with internal and external key stakeholders; review and evaluate data, author study reports and protocols;
  • Facilitate and oversee method trouble shooting, transfer and method validation among CROs;
  • Apply solid understanding and hands-on experience in in vitro/in vivo drug metabolism and pharmacokinetics to advance discovery programs;
  • Author and/or review GLP bioanalytical study protocols and reports, and relevant bioanalytical sections of regulatory filings;
  • May supervise and mentor junior scientists.
 
     
  Requirements:  
 
  • MS or PhD in chemistry, biochemistry or life sciences with 7+ years of pharmaceutical industry experience in bioanalytical or analytical development;
  • A minimum 5 years of experience in method-development of LC–MS/MS methods and quantitative measurement of small molecules / peptides in complex matrices, preferably in a regulated environment;
  • Extensive experience with bioanalytical sample preparation techniques such as LLE, SLE, protein precipitation and SPE, chromatographic techniques (incl. UPLC) and mass spectrometry (including Sciex triple quadrapole instruments);
  • Some experience with common pharmacokinetic modeling and distribution methods using WinNonlin or other software;
  • A track record of successfully managing external vendors is essential;
  • Knowledge of GLP/GCP guidance and best practices during clinical development and registration;
  • Good understanding of method qualification or validation requirements leading to product approval and commercialization;
  • Proven ability to thrive in a collaborative and cross-functional environment;
  • Excellent communication, interpersonal and mentoring skills and the ability to facilitate constructive, expedient problem solving;
  • Experience in drug metabolite ID and ADME study design and execution is a plus.
 
 

 
     
 
If you are interested in exploring employment opportunities at Catabasis, please send your cover letter and resume to careers@catabasis.com.