The Scientist, Formulation Development will be responsible for supporting formulation of solid oral drug products to support clinical development though registration and initial commercialization. The primary functions encompass product development and manufacturing with secondary functions supporting the other pharmaceutical sciences departments as required. Responsibilities include supporting the development and progression of the Neurocrine Biosciences drug product candidates; designing and conducting appropriate experimentation to support the development of the lead product candidates in a manner consistent with corporate goals and regulatory requirements; and supporting interactions with other internal teams at Neurocrine and with third party Contract Manufacturing Organizations.
Primary Duties and Responsibilities
- Supports product development efforts for multiple NCEs at all stages of clinical development, including formulation & manufacturing process development and scale-up.
- Serve as technical lead and project management support on multiple projects simultaneously.
- Support operations within Neurocrine Drug Product Manufacturing Laboratory, including excipient & component inventories, equipment procurement, qualification and maintenance, and small-scale manufacture of prototype solid oral dosage forms.
- Provides Person-in-Plant oversight of manufacturing activities as needed and serves as technical contact with CMOs to facilitate information and operational requirements between parties.
- Designs and performs laboratory experiments to determine the appropriate formulation and manufacturing process of Neurocrine drug candidates for clinical and registration-market image studies.
- Summarizes experimental findings, review and perform data analysis, and present study conclusions and updated plans to management in departmental, CMC and joint meetings with external partners/CMOs.
- Writes technical protocols, reports, regulatory submissions and patent applications.
- Provides training to new staff and less experienced departmental staff as needed.
- Identifies and communicates critical path activities along with any risks, issues or resource requirements pertaining to product development of the Neurocrine drug product candidates.
- Collaborates with and supports all Pharmaceutical Sciences staff to provide material and information in support of product development and manufacturing.
- Follows current GLP and GMP regulations.
- Maintains research records and lab notebooks in a concise, legible and complete manner.
- Carries out job responsibilities and assignments safely and maintains a clean and safe work area.
- Ph.D. in pharmaceutical science or related discipline, and 3 plus years in biotech/pharmaceutical product development; or MS in related field plus 5 years or more related experience; or BS plus 10 or more years’ experience in biotech/pharmaceutical product development.
- Hands-on experience in oral formulation development of new chemical entities including experience in extended and/or targeted release systems; experience operating within the Sponsor-CMO interface.
- Knowledge of GXPs, ICH guidelines, FDA and EMA/CHMP (and other international) regulatory requirements, clinical manufacturing, and quality assurance/quality control practices
- Strong facilitation, organizational, analytical and time management skills.
- High attention to detail, excellent written (i.e. technical writing) and oral communication skills, and the ability to work in a fast-paced and team environment.
- Experience writing technical documents, reports and presentations.
- This job may necessitate working outside “regular” work hours.
- International and domestic travel expected up to 20%.
- Must have ability to lift objects up to 30 pounds.