Senior Associate Scientist, Specifications

Location: Onsite

We are seeking a Senior Associate Scientist, Specifications to support specification development and lifecycle management for drug substances and drug products in a GMP environment. This role will work cross-functionally to ensure specifications, stability data, and regulatory documentation meet company and regulatory standards.

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  Initiate and manage specification change controls within a GMP environment.

  
  
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  Review technical data and author and/or review technical documentation.

  
  
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  Author and review SOPs and protocols in compliance with internal policies and regulatory requirements.

  
  
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  Contribute to analytical and stability sections of regulatory submissions.

  
  
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  Assist in preparing responses to regulatory agency questions and requests.

  
  
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  Perform specification assessments for existing products and new molecules in development.

  
  
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  Maintain platform and program-level specification documents.

  
  
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  Provide technical and scientific support to cross-functional teams as needed.

  
  

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  QA or Regulatory experience within a GMP environment.

  
  
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  QC laboratory experience.

  
  
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  Strong working knowledge of GMP regulations.

  
  
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  Solid understanding of chemistry principles.

  
  
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  Experience reviewing and interpreting technical data and documentation.

  
  

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  BS or MS in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline.

  
  

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  Minimum of 2 years of relevant professional experience preferred.

  
  
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  Open to candidates with 10+ years of experience who bring strong technical depth and leadership capability.

  
  

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  Experience conducting stability studies in accordance with ICH guidelines.

  
  
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  Hands-on experience with HPLC and physico-chemical test methods.

  
  
  
  
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    Oligonucleotide experience strongly preferred; experience with oligosaccharides or proteins is also acceptable.

    
    
  
  
  
  
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  Experience with Veeva and/or other electronic data processing systems.

  
  
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  Statistical analysis experience.

  
  

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  Strong team player who collaborates effectively across functions.

  
  
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  Proactive, self-motivated, and comfortable working independently.

  
  
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  Detail-oriented with strong analytical and problem-solving skills.

  
  
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  Interest in continuous improvement and process optimization.

  
  
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  Excellent written and verbal communication skills.

  
  
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  Comfortable preparing and delivering technical presentations.

  
  

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