Title: Principal Scientist
Salary: 150k-170k
Company Summary: Do you want to change the lives of the people that you work with? Serving patients is our company's number one priority. Achieving greatness, together, is the goal everyday within the world's leading biotechnology company. Manufacturing, researching, and delivering top-shelf products that extend to more than 10 million patients all over the world.
The Principal Scientist will be responsible for:
- Providing leadership to teams to create commercial manufacturing processes for small and hybrid molecules. Provide expertise and mentorship to junior staff
- Implementing strategies for development of late phase clinical programs that include both optimization as well as analytical method development
- Working with product development teams along with leading small molecule programs in clinical process development
- Oversee the transfer of methods and aid with cGMP manufacturing at both internal and external manufacturing and testing facilities
- Write technical reports and analytical CMC sections in regulatory documents and answer to health authorities about product quality
- Show expertise in of company's platform and analytical technologies by being innovative and efficient within Process Development
- Contribute to the development that increase the Attribute Sciences departments efficacy
- Stay up to date on cutting edge literature and technology in the analytical development field in order to provide new methodologies
The Principal Scientist should have the following qualifications:
- Bachelor's degree and 7 years of Scientific experience OR
- Master's degree and 5 years of Scientific experience OR
- Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience
Preferred Qualifications:
- Exemplary writing skills and attention to detail in writing specifications, technical reports, regulatory filing documents, and methods
- Be able to make decisions, multi-task, and solve problems while leading a team and work cross-functionally/globally within CMC teams
- Non-GMP and GMP production experience for technical transfer
- Knowledge of early phase development, ICH, FDA, impurities, and genotoxic impurities
- Strong understanding of small molecule analysis (spectroscopic techniques & chromatographic)
Benefits:
- Retirement & Saving Plan with company contributions, dental and vision coverage, life and disability insurance, flexible spending accounts, and group medical
- Annual bonus program OR (field sales representatives) a sale- based incentive plan
- Remote work arrangements
- Award winning time-off plans & bi-annual company-wide shutdowns
- Stock-based long-term incentives
If you are interested in the Principal Scientist role, then please don't wait to apply.
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