Scientist I - Biologics CMC Development

Our client, a global leader in biotechnology, is seeking a highly motivated Scientist I to join its Formulation Drug Development team for Foster City, CA.


Duration: Long term contract (Possibility of further extension)
Pay Rate: $62/hr on W2 + Medical Benefits, Paid Sick leave, 401K

This role will focus on advancing biologic medicines into clinical development through innovative formulation development, drug product (DP) process development, and clinical in-use evaluations. The ideal candidate will bring hands-on laboratory experience, technical expertise in biologics formulation and process development, and the ability to collaborate with cross-functional teams to drive scientific innovation and support clinical-stage development

Responsibilities:

• Design and execute formulation and drug product process development activities, including formulation development, drug product manufacturing process development, and clinical in- use evaluations.
  
• Drive scientific innovation, expand technical expertise, and contribute to publications, presentations, and external scientific collaborations.
  
• Apply knowledge of analytical techniques, biophysical characterization, and process development methods to support drug product development.
  
• Lead by example in laboratory execution and contribute to the development of new technical capabilities.
  
• Ensure data integrity and adherence to Good Documentation Practices (GDP) in data collection, analysis, and report generation.
  
• Critically review internal and external technical documentation for accuracy, completeness, and compliance.
  
• Author technical documents, including protocols, reports, and regulatory dossier materials for internal and external stakeholders.
  

Required Qualifications

• Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or a related scientific field with 0+ years of relevant experience; or
  
• M.S. degree with 6+ years of industrial experience in biologics CMC development; or
  
• B.S. degree with 8+ years of industrial experience in biologics CMC development.
  
• Hands-on laboratory experience in biologics formulation or drug product process
  
• development.
  
• Experience in biologics CMC development and technical documentation.
  

Preferred Qualifications:

• Experience in formulation development, drug product process development, and clinical in- use evaluation for:
  

• Monoclonal antibodies (mAbs)
  
• Bispecific antibodies
  
• Antibody-drug conjugates (ADCs)
  
• Fusion proteins
  
• Other complex biologics formats
  

• Experience with analytical methods, biophysical characterization, or drug product process development techniques.
  

Please respond with your updated resume & contact information to hr@dawarconsulting.com/kavitha@dawarconsulting.com
Best Regards,
DAWAR CONSULTING INC.