Senior/Principal Scientist, Analytical Development in Cambridge, MA at APEX Systems

Date Posted: 9/4/2019

Job Snapshot

Job Description

Job #:  961884
Senior/Principal Scientist, Analytical Development, 961884
Job Scope & Purpose:
Our exceptional Cambridge based client, focusing on the potential of genome editing for a variety of programs in rare diseases, is seeking a talented, highly-motivated individual to lead an Analytical Development team focused on developing analytics to support process development and manufacturing.  This person will lead several junior associates and lead from the bench, characterizing RNP complexes to be used in translational clinical studies.  The ideal candidate will have experience in nucleic acid and protein-based therapies at a minimum, and preferably expertise in viral vector characterization.
Primary Job Responsibilities:
  • Manage and lead a cross functional team to develop analytics to support process development and manufacturing of CRISPR nuclease proteins and RNP complexes to support gene-edited cell therapy programs
  • Develop methods to support formulation development and work with Process Development team to generate and analyze data in order to determine proper storage conditions and buffer formulations of gene-editing components (nuclease proteins and guide RNAs), and RNP complexes
  • Interface with cross-functional leaders to achieve successful clinical translation
  • Review and author documentation, including SOPs, development reports, electronic lab notebook reports, sample plans, certificates of testing, etc.
  • Transfer RNP and protein analytics to external testing partners, Contract Development and Manufacturing Organizations, or internal QC labs

Primary Job Requirements:
  • MS or PhD with at least eight years of experience in cell or gene therapy, or biotech experience
  • Previous experience in developing nucleic acid and protein-based therapies required, with experience in viral vector characterization strongly preferred
  • Technical experience in developing and qualifying biophysical (HPLC/UPLC, mass spec, capillary electrophoresis), molecular (qPCR), immunological (ELISA), and cell-based potency assays required
  • Strong knowledge of regulatory requirements for critical process materials and process components, FDA/ICH regulations, and QC principals for GMP operations
  • Strong communication, organizational and leadership skills, with the ability to train, manage and guide junior scientists, work efficiently within a matrix multi-disciplinary team, and work with external partners/vendors

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
 
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
tjamison@stratacuity.com
 
Code: TechOps
 
 
 
 
 
 
 
 
EEO Employer
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.