What are the responsibilities and job description for the Pharmaceutical Formulations Specialist position at Chartwell Pharmaceuticals?
About the Role
We are seeking a highly skilled Senior Scientist to join our team at Chartwell Pharmaceuticals, LLC. As a Senior Scientist, you will be responsible for providing 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 is an excellent opportunity to build your career with a fast-growing and dynamic generic pharmaceutical company.
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 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
Qualifications:
- 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
- Experience 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 and synthesize into meaningful observations and action plans
- Be challenge driven, flexible, and willing to take on extra responsibility to achieve organizational goals
- Superior communication skills (verbal, written, and presentation)
- Highly ethical and transparent with professional sensitivity and care for confidentiality
- Must have proficient computer skills