Director Formulation Development
Posted on Apr 6, 2021 by ACADIA Pharmaceuticals
Director Formulation Development will be responsible for the formulation and process development, scale-up, and production of dosage forms for clinical trials and commercial drug products. Responsible for identifying, contracting and managing external vendors as well as providing oversight of the outsourced activities while operating in the virtual environment. Responsible for the communication of project status and issues, and ensures the project team goals and deliverables are met.
Designs and develops formulations and manufacturing processes to support clinical trials, registration and commercial product launch.
Ensures appropriate technical, scale-up, and production strategies and timelines are in place to meet the clinical supply and registration needs, and ensures technology transfer, validation and regulatory outcomes are met.
Consults and interacts closely with other departments to define the formulation and manufacturing processes within the constraints of clinical, legal, analytical, regulatory and production requirements.
Plans project-related scientific and technical activities, eg interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
Prepares pharmaceutical development reports and other technical documentation required for regulatory submissions, including authoring, review and approval of requisite sections of the IND, CTA, IMPD, NDA, MAA or other filings.
Manages external vendors, such as Contract Research Organizations (CROs) and Contract Manufacturing organizations (CMOs) throughout product development life cycle.
Adheres to cGMP work practices and works closely with the Quality organization to ensure strict compliance with applicable GXP procedures and compliance requirements.
Other responsibilities as assigned.
Master's degree in Pharmaceutical Sciences or a related field. Ph.D. highly preferred. Equivalent combination of relevant education and applicable job experience may be considered.
A minimum of 12 years progressively responsible experience in pharmaceutical development with a focus on oral solid and liquid dosage forms. A minimum of 5 years in a leadership role is required and experience leading cross functional teams is preferred. Demonstrated ability to write technical and or scientific documents. Demonstrated success in the field of formulations and oral dosage form development, with some exposure to combination products, modified release and injectable dosage forms is preferred.
Comprehensive understanding of the dosage formulation development process for new chemical entities.
Comprehensive understanding of the dosage form manufacturing process development, scale-up, optimization and validation processes.
Extensive knowledge of cGMPs and past experience in development of NDAs.
Expert knowledge of advanced principles, concepts, and theory related to product and process development.
Skilled at managing CROs and CMOs.
Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and division goals.
Ability to inspire and energize others through expert technical knowledge, personal leadership, influence, and thorough planning and drive for timely and appropriate results.
Flexibility to travel domestically and internationally