Qureos Mentor

Planet Pharma

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 Location:
 
 Cambridge, MA (Onsite)
 
 
 
 Contract Length:
 
 12 months
 
 
 
 Target Pay Rate:
 
 $47&ndash;48/hr
 
 
 
 
 
 
 Overview:
 
 
 
 We are seeking a detail-oriented and proactive
 
 Senior Associate Scientist, Specifications
 
 to support the specification management of siRNA drug substances and drug products. This fully onsite role in Cambridge, MA, offers the opportunity to contribute to GMP-compliant operations, regulatory submissions, and specification oversight. The position is a 12-month contract with potential for expanding analytical scope beyond data verification.
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Initiate and manage specification change controls in a GMP environment.
 </li>
 <li>
 Review data and author/review technical documentation, SOPs, and protocols.
 </li>
 <li>
 Contribute to analytical and stability sections of regulatory submissions and assist with agency requests.
 </li>
 <li>
 Perform specification assessments for existing and new products.
 </li>
 <li>
 Maintain platform program specification documents.
 </li>
 <li>
 Provide technical support across projects as needed.
 </li>
 </ul>
 
 
 Required Qualifications:
 
 
 <ul>
 <li>
 BS or MS in Chemistry, Biochemistry, Analytical Chemistry, or related field.
 </li>
 <li>
 Minimum 2 years of professional experience in a cGMP analytical laboratory environment.
 </li>
 <li>
 Strong understanding of chemistry, QA/QC, and regulatory requirements.
 </li>
 <li>
 Experience working with and reviewing technical data and documentation.
 </li>
 </ul>
 
 
 Preferred Qualifications:
 
 
 <ul>
 <li>
 Experience with stability studies conducted per ICH guidelines.
 </li>
 <li>
 Hands-on experience with HPLC and physico-chemical test methods (oligonucleotides preferred; oligosaccharides or proteins acceptable).
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 Familiarity with Veeva or similar data processing systems.
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 Experience in statistical analysis.
 </li>
 </ul>
 
 
 Soft Skills:
 
 
 <ul>
 <li>
 Team player with strong interpersonal skills.
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 Self-motivated, detail-oriented, and analytical.
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 Able to work independently and contribute to process improvements.
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 <li>
 Excellent written and verbal communication skills; comfortable preparing and delivering presentations.
 </li>
 </ul>
 
 
 Work Hours &amp; Environment:
 
 
 <ul>
 <li>
 Standard business hours, with very rare weekend work.
 </li>
 <li>
 Fully onsite in Cambridge, MA, with potential travel between sites.
 </li>
 <li>
 Bloodborne pathogen exposure: None.
 </li>
 </ul>
 
 
</div>

Senior Scientist

Join Planet Pharma and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Planet Pharma

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Senior Scientist