Manager, Formulation Development
The Manager, Formulation Development will be responsible for formulation development and clinical manufacturing of drug products for drug candidates to support preclinical studies, clinical development, 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 overseeing and implementing 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 initiating and leading interactions with other internal teams at Neurocrine and with third party vendors.
Primary Duties and Responsibilities:
- Represents product development efforts to senior leadership, department management and project team leaders to identify and resolve issues related to product development.
- Serves as a 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 preclinical, toxicology, 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.
- 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.
- BS/MS in pharmaceutics, engineering, chemistry or related discipline, and 10 plus years in biotech/pharmaceutical product development; or MS in related field plus 8 years or more related experience; or BS plus 12 or more years experience in biotech/pharmaceutical product development.
- Extensive hands-on experience in oral formulation development of new chemical entities including experience in extended and/or targeted release systems.
- Knowledge of cGMP, clinical manufacturing, and quality assurance/quality control practices; extensive experience in the management of CMOs.
- Proven ability to manage multiple and diverse issues.
- Strong facilitation, organizational, analytical and time management skills.
- High attention to detail, excellent written and oral communication skills, and the ability to work in a fast-paced and team environment.
- Experience writing technical and management documents, reports and presentations.
- This job may necessitate working outside “regular” work hours.
- International and domestic travel expected up to 25%.
- Must have ability to lift objects up to 30 pounds.