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.
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