Position Overview:
Scientist in Analytical Development will assume a pivotal role within the Technical Development department, executing against and supporting oversight of the analytical functions (method development, qualification, routine testing, and new technology evaluation) that are integral to the successful development and manufacturing of cell and gene therapy products for new or existing clients.
We are seeking a highly motivated and skilled Research Associate to join our Analytical Development team. The successful candidate will play a crucial role in the design, execution, and interpretation of analytical experiments to support the development of our therapeutic candidates.
Key Responsibilities:
- Lead the design, optimization, and validation of analytical methods for the analysis of small molecules, peptides, proteins, and other biologics using techniques such as HPLC, LC-MS, SEC, and spectroscopy.
- Apply advanced analytical techniques to investigate the physicochemical properties, stability, and purity of drug substances and drug products throughout development stages.
- Collaborate closely with cross-functional teams to ensure alignment of analytical strategies with project goals and regulatory requirements.
- Provide scientific expertise and guidance on method development, troubleshooting, and data interpretation to support project advancement.
- Contribute to the preparation of regulatory submissions, including analytical sections of INDs, BLAs, and IMPDs.
- Mentor and train junior team members, fostering a culture of scientific excellence, collaboration, and continuous learning.
- Maintain up-to-date knowledge of industry trends, regulatory guidelines, and emerging technologies in analytical development.
Benefits:
Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Employer-Paid Basic Life Insurance
- Supplemental Life Insurance
- Employer-Paid Short-Term Disability
- Long-Term Disability
- 401(k) Plan
- Paid Time Off
- Paid Holidays
