Senior Associate Scientist

2 weeks ago


Cambridge, United States Proclinical Staffing Full time

Senior Associate Scientist- Contract- Cambridge, MA

Proclinical is seeking a dedicated and detail-oriented Senior Associate Scientist to support stability and specification tasks for siRNA drug substances and drug products.

Primary Responsibilities:

The successful candidate requires a proactive individual who can manage specification change controls in a GMP setting, contribute to general laboratory operations, and provide technical support as needed.

Skills & Requirements:

  • Degree in Chemistry, Biochemistry or related disciplines.
  • Previous experience in a cGMP analytical laboratory environment.
  • Experience with stability studies designed and conducted in accordance with ICH guidelines is preferred.
  • Team player and open to change.
  • Excellent communication and presentation skills.
  • Experience with HPLC and physico-chemical test methods of oligonucleotides, oligosaccharides or proteins is preferred.

The Senior Associate Scientist's responsibilities will be:

  • Initiate and manage specification change controls in a GMP setting.
  • Contribute to general laboratory operations including data review and authorship/review of technical documentation.
  • Author and review SOPs and protocols in line with company and regulatory guidelines.
  • Contribute data to analytical and stability sections of regulatory submissions and assist with responses to agency requests on these sections.
  • Assess specifications of existing and new products.
  • Support in maintaining platform program specification documents.
  • Meet goals supporting studies and defining specifications for new molecules in development.
  • Ensure on-time and compliant completion of stability data to support clinical supply.
  • Implement stability and specifications for product registration.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.



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