Director, Technical Operations (CMC) Job at Rigel Pharmaceuticals in South San F
Rigel Pharmaceuticals, South San Francisco, CA, United States
POSITION 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, 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:
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.
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
- 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
- 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.