Senior Associate Scientist

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.