Senior Formulation Scientist/Principle Formulation Scientist

Reference IDMed007
TypePermanent
Specific Duties and Responsibilities:
Our growing R&D lab is looking for talented Senior Formulation Scientists to join our group. 

Responsibilities include:
  • Lead formulation development of parenteral formulations in a product development environment using QbD principles. 
  • Lead activities with help of other scientists, chemists for various formulation development studies required for ANDA and NDA product development of Parenteral drug products - Liquid and lyophilized formulations.
  • Plans, develops and implements scientifically well-designed experimental program with minimal supervision. 
  • Maintain experimental records, procedures to meet cGMP requirements. 
  • Participate in the review process for appropriate department SOPs, study protocols, and reports.
  • Participate in the training of incoming laboratory staff.
  • Participate as needed in departmental efforts directed toward equipment maintenance, calibration, and qualification.
  • Coordinate technology Transfer to internal commercial site and CROs/CMOs
  • Author formulation development activities for Chemistry, Manufacturing and Control (CMC) document for Regulatory submission. 
  • Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule. 
  • Provide crucial support to other team members in the conduct of their studies.  
Required Competencies:
Education Minimum / Recommended:

  • Ph.D. in Pharmaceutics or other related field with 3+ years� experience 
  • MS in Pharmaceutics or other related field with 5+ years� experience 
  • BS in Pharmaceutics or other related field with 7+ years� experience 

Work Experience Required:

  • Minimum 3 to 7+ years of experience is required.
  • Experience in complex sterile injectable products including suspensions, emulsions, oncology products and drug device combination products containing either small molecule or Peptide APIs is a plus.

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