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Senior Scientist Analytical Development
2 months ago
We are looking for an experienced Senior Scientist in Analytical Development specializing in Radiopharmaceuticals to join our innovative team. In this role, you will lead the development and validation of analytical methods to support the characterization and quality control of radiopharmaceutical products.
Key Responsibilities:
- Design and develop robust analytical methods for the characterization of radiopharmaceuticals, including chromatography, mass spectrometry, and other relevant techniques.
- Oversee method validation and provide technical guidance to ensure compliance with regulatory requirements.
- Collaborate closely with cross-functional teams, including formulation, quality assurance, and regulatory affairs to support product development and release.
- Conduct complex data analysis and interpretation, presenting findings to stakeholders.
- Write and review regulatory documentation, including IND and NDA submissions.
- Mentor junior scientists and foster a collaborative research environment.
Requirements
Qualifications:
- Ph.D. in Analytical Chemistry
- 5+ years of experience in pharmaceutical analytical development, with a focus on radiopharmaceuticals preferred.
- Strong expertise in analytical techniques such as HPLC, GC, and mass spectrometry.
- Experience with regulatory submissions and compliance (e.g., FDA, EMA).
- Excellent problem-solving skills and ability to work independently and as part of a team.
- Strong written and verbal communication skills.
- Ability to manage multiple projects and meet deadlines in a fast-paced environment.
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave (Maternity, Paternity)
- Short Term & Long Term Disability
- Training & Development
- Flexible on site schedule
- Wellness Resources
- Stock Option Plan