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Job type: Contract

Discipline: Good Manufacturing Practice (GMP)

Location: United States

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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