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Job type: Contract

Discipline: Analytical Chemistry

Location: United States

Senior Associate Scientist - Contract - Cambridge MA

Join a cutting-edge pharmaceutical team where your precision and passion for quality will help shape the future of life-saving medicines!

Proclinical is seeking a Senior Associate Scientist to support the development and management of specifications for siRNA drug substances and drug products.

Primary Responsibilities:

This role involves working in a GMP environment and contributing to various technical and operational aspects, including data review, documentation, and regulatory submissions.

Skills & Requirements:

Degree in Chemistry, Biochemistry, or a related field.
Experience in a cGMP analytical laboratory environment.
Familiarity with stability studies designed per ICH guidelines (preferred).
Strong teamwork and adaptability skills.
Excellent communication and presentation abilities.
Experience with HPLC and physico-chemical test methods for oligonucleotides, or alternatively, for oligosaccharides or proteins (preferred).

The Senior Associate Scientist's responsibilities will be:

Initiate and manage specification change controls in a GMP setting.
Review data and author/review technical documentation.
Provide technical support as needed.
Author and review SOPs and protocols in compliance with company and regulatory guidelines.
Contribute to data review and analytical/stability sections of regulatory submissions.
Assist with responses to agency requests related to these sections.
Assess specifications for existing and new products.
Support the maintenance of platform program specification documents.
Ensure timely and compliant review and verification of stability data to support clinical supply.
Implement stability and release specifications for product registration.

Compensation:

$45 to $50 per hour.

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

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy

Salary

Highly Competitive

Location:

Wilmington, USA

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