We are partnering with a generic pharmaceutical company in Carlsbad, CA to help identify a Principal Scientist to join the team! They are working towards becoming a US leader in generic injectable drugs while striving to make therapies more accessible through their development portfolio of high barrier products.
The Principal Scientist w responsible for the accomplishment of analytical methods development and Good Manufacturing Practice (GMP) analytical methods validation, stability, protocol studies and transfer related tasks required for the U.S. Food and Drug Administration (FDA) submission of new as well as marketed products. The position reports to the Director, Product Development.
The ideal Principal Scientist will have confidence in providing subject matter expertise surrounding analytical method development, troubleshooting of analytical methods, reviewing the stability of data and specification settings. The Principal Scientist will be responsible for managing method development validation, stability, protocol studies and methods transfer. This individual must have confidence in their abilities to support cross-functional teams consisting of professionals from Research & Development, Quality, Regulatory, Project Management, Finance, Contract Research Organizations (CROs), and Contract Manufacturing Organizations (CMOs) in relation to FDA filings, FDA comment letters and due diligence efforts as needed.
The Principal Scientist will be responsible for, but not limited to:
- Developing analytical methods in a timely manner to support regulatory filings.
- Facilitating specification settings for drug substance and drug product.
- Partnering with Development Scientists, CROs, and CMOs to ensure timely validation, transfer of analytical methods, and stability testing for new and existing products to support a timely FDA filing.
- Supporting responses to comments from the FDA.
- Providing technical feedback to request proposals from CROs and providing proposal comments.
- Developing, reviewing, and approving protocols, reports, and project schedules for projects.
- Working within a cross-functional environment.
- Adjusting work hours as needed to meet with global partners.
- Supporting due diligence activities.
- Laboratory management.
- Other duties as assigned.
Requirements for the Principal Scientist:
- MS degree in Chemistry or closely related field; Advanced degree (PhD) is preferred.
- Minimum of 10 years of experience in parenteral pharmaceutical industry.
- Experience in managing and developing teams and/or direct reports.
- Demonstrated successful team leadership experience.
- Preferred experience in injectable suspensions (dissolution methods).
- Ability to work in a diverse and dynamic work environment.
- Ability to travel locally and internationally (to CROs and CMOs) as needed.
- Demonstrated knowledge of pharmaceutical analytical methods development, validation, transfer, troubleshooting, specifications, stability and experimental design.
- Strong experience in methods development, validation and troubleshooting in a GMP atmosphere.
- Excellent written and verbal communication skills.
- Excellent investigative and implementation skills.
- Excellent time management and organizational skills.
- Strong team player with a can-do attitude.