Pharmaceutical Formulation Development Specialist

7 days ago


Amityville, New York, United States Chartwell Pharmaceuticals Full time

About the Role

We are seeking a skilled Pharmaceutical Formulation Development Specialist to join our team at Chartwell Pharmaceuticals. This is an excellent opportunity to build your career with a fast-growing and dynamic generic pharmaceutical company.

Job Summary

The successful candidate will provide scientific, technical and hands-on support of Formulations and Technical Transfers of previously approved dosage forms into the Chartwell Pharmaceuticals sites, or to 3rd party sites. The ideal candidate will have a current understanding of formulation development, QbD, and tech transfer process from kick-off through validation.

Key Responsibilities

  1. Design, conduct and troubleshoot benchtop formulation experiments independently.
  2. Evaluate and document key ANDA/NDA approval details.
  3. Execute lab scale, scale up and validation batches.
  4. Perform gap analysis and characterize the changes required for formulations.
  5. Compile data, prepare product development reports and author technical reports for submission/validation batches.
  6. Operate small scale up manufacturing equipment to replicate to full scale.
  7. Identify problems, troubleshoot and offer solutions to advance assigned projects.

Requirements

  • Bachelor or Master's degree in a related scientific discipline desired.
  • Minimum 8 years of Pharmaceutical formulation and process development, technology transfer and scale up experience supporting technical and operational activities in various dosage forms.
  • Experience working in cGMP environment and knowledge in regulatory guidance.
  • Superior problem solving, organizational and analytical skills, highest attention to detail, and ability to proactively seek multiple internal and external data sources and insights and synthesize into meaningful observations and action plans.
  • Superior communication skills (verbal, written and presentation).
  • Highly ethical and transparent, with professional sensitivity and care for confidentiality.

Work Location

This position is based in Amityville (Long Island) NY and we only seek candidates from the New York Metropolitan area.

Salary Information

The estimated salary for this position is $120,000 per year, depending on qualifications and experience.



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