- Develop and execute strategies/plans of manufacturing and supply of drug substance and drug product for commercial and development programs
- Manage evaluation/selection of development candidates, formulation/product development, method development, and analysis/release testing and stability studies of drug substance and drug product
- Interface with research organization to support formulation of preclinical candidates for in vivo testing
- Lead and execute CMC development activities from the design of the molecule to writing the CMC section of the NDA including evaluating and selecting CMC services providers, negotiating contracts, and reviewing the CMC section for INDs and IMPDs
- Author CMC sections for regulatory filing, investigator brochure and study protocol
- Evaluate and select contract manufacturers for drug substance and drug product. Negotiate contracts, plan, and manage development work and cGMP manufacturing at contract manufacturers
- Establish and manage CMO relationships to ensure API/drug substance, finished dosage form and related packaging operations are completed in compliance with cGMP requirements
- Interface with Planning, Clinical Operations, and Commercial Operations to assess and determine required quantities of materials. Develop supply strategy to address these needs and direct team responsible for all aspects of drug manufacture at CMOs
- Assess project/program needs, plan for internal and external resources and act accordingly to ensure adequate and timely support
- Manage and oversee supply chain from sourcing raw materials for API manufacturing to ensuring bulk product production, to packaging/labeling and delivering commercial and clinical trial materials
- A Ph.D. or equivalent experience in Chemistry, Biology, Biochemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field
- A minimum of 15 years of pharma/biotech industry experience in drug development including experience in clinical drug development, commercialization, and regulatory knowledge. Minimum of 7 years experience managing CMOs
- Strong scientific knowledge and understanding of product development with relevance to pharmaceutical manufacturing including API chemical synthesis, drug product manufacturing, and packaging
- Knowledge of GMP regulations, ICH guidelines; as well as CMC content of regulatory submissions
- Knowledge of structure/function and appropriate analytical methods used in product characterization
- Research, preclinical, development, and management experience in pharmaceutical operations
- Proven skills in building teams, supervising personnel, and completing projects.
- Expertise in Pharmaceutics and Manufacturing and managing entire supply chain.
- Demonstrated ability to lead teams and bring in projects on budget/deadline while maintaining study's scientific integrity and adherence to FDA guidelines
- cGMP Manufacturing experience
- Proven leadership experience
- Demonstrated ability to work within a multi-disciplinary team of peers and outside experts
- Excellent communication (verbal and written) and presentation skills
- Proficient computer skills
- 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. Exposure to chemicals.
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VP, Technical Operations CMC - South San Francisco, United States - Rigel Pharmaceutical
Description
Job Description
Job DescriptionPOSITION SUMMARY:
Responsible for providing short and long-term strategic vision, leadership, and execution of all aspects of the pharmaceutical technical operations. Provide and ensure adequate support to all pharmaceutical needs of commercial and development programs. Support formulation development for research programs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
KNOWLEDGE AND SKILL REQUIREMENTS:
WORKING CONDITIONS:
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.
