Pharmaceutical Formulations Specialist

1 week ago

Amityville, New York, United States Chartwell Pharmaceuticals Full time
About Chartwell Pharmaceuticals

Chartwell Pharmaceuticals, LLC is a privately-held, US-based generic pharmaceutical manufacturer with a strong presence in the market. With over 999 ANDA listings in the FDA Orange Book, we are rapidly growing and transforming our business as a full-scale Generic Pharmaceutical Manufacturer and Distributor serving the Retail, State and Federal Government Markets under the "Chartwell Rx" labels.

Job Summary

We are seeking a highly skilled and experienced Senior Scientist to provide scientific, technical, and hands-on support of Formulations and Technical Transfers of previously approved dosage forms into our sites or to 3rd party sites. This position will work with solids, liquids, semi-solids, ophthalmic/otic, and injectable products, and must have a current understanding of formulation development, QbD, and tech transfer process from kick-off through validation.

Key Responsibilities
  • Design, conduct, and troubleshoot benchtop formulation experiments
  • Evaluate and document key ANDA/NDA approval details
  • Execute lab scale, scale up, and validation batches
  • Perform gap analysis and characterize the changes required for formulations
  • Record experiments in laboratory notebooks
  • Compile data, prepare product development reports, and author technical reports for submission/validation batches
  • Perform scale-up studies and prepare technical transfer report for cGMP manufacturing
  • Operate small scale up manufacturing equipment to replicate to full scale
  • Identify problems, troubleshoot, and offer solutions to advance assigned projects
  • Work with operations team to ensure equipment and capacity readiness for all required work
  • Provide clear and accurate verbal and written reporting of technical activities
  • Provide product status, with relevant materials for decision support
  • Maintain Research and Development pilot plant equipment/instruments
  • Meet project timelines and performance standards as assigned
Requirements
  • Bachelor or Master's degree in a related scientific discipline
  • Minimum 8 years of Pharmaceutical formulation and process development, technology transfer, and scale up experience
  • Experience and working in cGMP environment and knowledge in regulatory guidance
  • Superior problem solving, organizational, and analytical skills
  • Ability to proactively seek multiple internal and external data sources and insights
  • Superior communication skills (verbal, written, and presentation)
  • Highly ethical and transparent, with professional sensitivity and care for confidentiality
  • Must have proficient computer skills
Location

This position is based in Amityville, NY, and we only seek candidates from the New York Metropolitan area. Sponsorship is not available for this position. Agency referrals are not accepted.

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