Director, Technical Operations (CMC) Job at Rigel Pharmaceuticals Inc. in San Fr

Career Opportunities with Rigel Pharmaceutical A great place to work. Join Our Team Share with friends or Subscribe! Are you ready for new challenges and new opportunities? Current job opportunities are posted here as they become available. Subscribe to our RSS feeds to receive instant updates as new positions become available. The Director, Technical Operations (CMC) is responsible for providing strategic leadership and oversight of drug product development with a primary focus on oral solid dosage (OSD) formulations. This role is accountable for formulation development, process scale-up, validation, and lifecycle management, while ensuring reliable support of clinical and commercial manufacturing. The Director operates with a high degree of independence and is responsible for establishing functional strategies, driving cross-functional alignment, and ensuring execution of CMC objectives. This role also provides leadership for packaging, labeling, and serialization design, validation, and lifecycle management to ensure compliant and uninterrupted global supply. Salary range: $200,000 to $240,000 ESSENTIAL DUTIES AND RESPONSIBILITIES Establish and execute CMC strategies for OSD drug product development and lifecycle management from early development through commercialization Provide technical leadership for formulation development, including preformulation, formulation design, process development, scale-up, and validation Lead and oversee activities at CDMOs related to drug product development, technology transfer, process validation, and commercial manufacturing Provide technical oversight and support for ongoing clinical and commercial manufacturing, including review of batch records, deviations, investigations, CAPAs, and change controls Lead packaging and labeling development activities, including design, material selection, qualification, and lifecycle management Oversee serialization strategy and implementation, including system design, validation, aggregation, and compliance with global regulatory requirements Ensure packaging, labeling, and serialization systems are maintained in a validated and compliant state throughout the product lifecycle Author, review, and approve CMC sections of regulatory submissions and support interactions with regulatory authorities Lead and influence cross-functional teams to ensure alignment of CMC activities with program timelines and business objectives Identify technical and operational risks and implement appropriate mitigation strategies Develop, manage, and mentor team members to build organizational capability and ensure effective execution Manage project timelines, budgets, and external vendors to ensure efficient use of resources Drive continuous improvement, lifecycle management activities, and post-approval changes to enhance product quality and supply reliability Perform data analysis and trending of manufacturing and analytical data to support process understanding and control strategy development Other duties as assigned KNOWLEDGE AND SKILL REQUIREMENTS: Bachelor's degree in Chemistry, Pharmaceutics, Chemical Engineering, or related scientific discipline required; advanced degree preferred Minimum of 12-15 years of relevant pharmaceutical industry experience in CMC with a strong focus on drug product development and OSD formulations Demonstrated expertise in formulation development, process scale-up, validation, and commercial manufacturing support Experience in packaging and labeling development, including design, qualification, and lifecycle management Working knowledge of serialization systems and global regulatory requirements (e.g., DSCSA, EU FMD) Proven track record of significant CMC contributions to successful regulatory submissions (e.g., IND, NDA, BLA, MAA), including authorship/review of Module 3 and responses to regulatory agency queries Demonstrated ability to manage multiple priorities across global teams and time zones, with adaptability in a fast-paced, dynamic development environment Proven leadership experience managing teams and influencing cross-functional stakeholders in a matrix environment Strong understanding of cGMP, ICH guidelines, and global regulatory expectations Experience working with CDMOs and external partners across global supply chains Strong project management, organizational, and problem-solving skills Excellent written and verbal communication skills with the ability to influence and drive decision-making Ability to manage multiple priorities and adapt in a dynamic environment WORKING CONDITIONS PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required. Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law. #J-18808-Ljbffr In Summary: The Director, Technical Operations (CMC) is responsible for providing strategic leadership and oversight of drug product development with a primary focus on oral solid dosage (OSD) formulations . This role is accountable for formulation development, process scale-up, validation, and lifecycle management . The Director operates with a high degree of independence . En Español: Oportunidades de carrera con Rigel Pharmaceutical Un gran lugar para trabajar. Únete a nuestro equipo Comparte con amigos o suscríbete! ¿Estás listo para nuevos desafíos y nuevas oportunidades? Las oportunidades laborales actuales se publican aquí cuando estén disponibles. Suscribirse a nuestros feeds RSS para recibir actualizaciones instantáneas a medida que aparezcan nuevos puestos. El Director, Operaciones Técnicas (CMC) es responsable de proporcionar liderazgo estratégico y supervisión del desarrollo de productos farmacéuticos con un enfoque primario en las formulaciones de dosis sólidas orales (OSD). Este papel también proporciona liderazgo en el diseño de embalajes, etiquetado y serialización, validación y gestión del ciclo de vida para garantizar un suministro global coherente e ininterrumpido. Rango salarial: $200,000 a $240,000 DUTIES ESENCIALES Y RESPONSABILITADES Establecer y ejecutar estrategias CMC para el desarrollo de productos farmacéuticos OSD y la gestión del ciclo de vida desde su primer desarrollo hasta su comercialización Proporcionar liderazgio técnico en el desarrollo formulario, incluyendo preformulación, elaboración de fórmulas, desarrollo de procesos, escalado y validación Dirigir y supervisar las actividades de los CDMOs relacionadas con el desarrollo del producto medicinal, transferencia de tecnología, validación de procesos farmacológicos y fabricación Comercial Disponer de capacidades técnicas mínimas y apoyo al desarrollo clínico y comercial, incluida la revisión de lotes, desviaciones, registros, CAPAs y controles de cambios Los miembros del equipo de administración se centran en mejorar sus competencias y gestionar los sistemas de gestión de datos sobre el proceso de producción de productos, así como desarrollar una aplicación adecuada y cumplimiento de los requisitos legales y la calidad de los procedimientos administrativos y otros programas de investigación y control de seguridad, comprometerse con la implementación y evaluación de los objetivos técnicos necesarios en el marco del programa de trabajo, evaluar y la ejecución de los niveles de funcionamiento del sistema químico, controlar y la eficacia y el uso de los sistemas operarios y la distribución de los equipos de los productos, implementar las funciones de los modelos de análisis y los sistemas comerciales, establecer y mantener una ampliación de conocimientos básicos y la capacidad de los recursos humanos y de los servicios, etc. Las habilidades de visión específicas requeridas por este trabajo incluyen la visión cercana, la visión a distancia, la vista periférica, la percepción de profundidad y la capacidad de ajustar el enfoque. ENVIRONMENTO DE TRABAJO: El nivel de ruido en el entorno laboral suele ser moderado. Algunos viajes pueden ser necesarios. Rigel Pharmaceuticals, Inc. es un empleador de igualdad de oportunidades, y todos los solicitantes calificados recibirán consideración para empleo sin tener en cuenta la raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estatus protegido del veterano, estado de discapacidad o cualquier otra característica protegida por la ley. #J-18808-Ljbffr