Principal Scientist/Associate Director, Process Development - LNP and Synthetic Virus

Cambridge, MA

Principal Scientist/Associate Director, Process Development (Synthetic Virus/LNP) 1106032

Job Scope and Purpose:

Our Cambridge based oncology focused company is seeking an exceptional candidate to lead technical CMC activities and process development initiatives for a novel new synthetic viral platform.  This ideal hire will lead a small team internally as well as identify and work with Contract Manufacturing Organizations to deliver GMP material to support future IND submissions.  This individual will run point in scaling up the company's synthetic viral platform and be a leader in a fast-growing CMC Operations group.  If you are excited about the opportunity to take pre-clinical programs from development and into the clinic and bring exciting new treatments forward, then this is the job for you.  Contact Kevin Rees for more information today! 

Primary Job Responsibilities:

  • Work with internal stakeholders in leading the effort to translate internal science into a robust and efficient GMP manufacturing process for synthetic viral programs
  • Contribute to CMO selection, facility fit assessments and development of batch production records
  • Use risk-based approaches to design and conduct experiments to identify and optimize critical process parameters, and characterize drug product manufacturing processes 
  • Manage CMO relationships
  • Establish methods for characterization of oligonucleotide and lipid nanoparticles
  • Prepare and review GMP and regulatory documents (batch records, deviations, investigations and, as needed, IND sections)
  • Supervise junior staff members within process development and technical operations, specific to synthetic viral programs

Primary Job Requirements:

  • PhD in a relevant field of study with a minimum of six years experience in the development and manufacturing of biologics. Candidates with a Masters degree and at least 10 years of relevant experience will be considered.
  • Demonstrated leadership in process development, scale-up, tech transfer and external manufacturing oversight
  • Must have strong familiarity with cGMP operations for large molecule production and purification, as well as knowledge of bioprocess purification operations as applied to viruses, DNA, RNA or similar biomolecules
  • Must have previous experience in developing either oligonucleotide and/or lipid nanoparticle drug products
  • Strong preference for an understanding of analytical methods required for characterization of oligonucleotides and/or lipid nanoparticles
  • Must have previous supervisory experience of junior personnel
  • Experience in authoring and reviewing sections of regulatory documents and CMC sections of submissions strongly preferred

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 Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 employeeservices@apexsystemsinc.com or 844-463-6178.