Tioma Therapeutics is an immune-oncology company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. Headquartered in Brisbane, CA, Tioma has a research center at St. Louis, MO. This position will be located in Brisbane, CA.
Tioma Therapeutics, Inc. is seeking a Director of CMC to join our team reporting to our Chief Development Officer. The Director will be a key member of the team and will partner with internal team leaders and external partners to develop and implement research and clinical projects to support our therapeutic programs. The ideal candidate will work with other cross-functional teams to support and enable the drug substance (DS) and drug product (DP) development, including designing and developing formulations and processes, optimizing and scaling up the manufacturing processes, manufacture, packaging and labeling of clinical trial materials (CTMs) in support of clinical studies.
Primarily, the role will:
• Lead the CMC function for the organization
• Work with contract manufacturers (CMO) for DS and DP to ensure on time delivery of materials along with analytical data
• Ensure that there is a timely preparation and submission of high quality CMC content for submissions of all types and their amendments and supplements
• Lend functional expertise to support all CMC related discussions, negotiations and responses with regulatory agencies
• Maintain up-to-date knowledge of relevant FDA and ICH requirements relating to CMC activities
• Other duties as assigned
• Bachelors degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or related field required, advanced degree preferred
• At least 8 years of experience in working with biologics (experience with monoclonal antibodies preferred) in the pharmaceutical industry
• Extensive experience in working with the CMOs for DS and DP
• Working knowledge of GMP
• Experience in preparing CMC submissions to regulatory agencies and direct interaction with regulatory authorities
• Demonstrated ability to contribute successfully in a multi-disciplinary team environment /matrix organization
• Competency in MS Office, MS Project
• Complex Problem solving abilities with focus on accomplishing company goals and objectives in a dynamic business environment
• Outstanding written and oral communication and negotiation skills are essential
• Strong leader with focus and drive to succeed—confidence, passion, results oriented and high energy
• Ability to present thoughts clearly and concisely to a wide variety of stakeholders including senior management, directors, and corporate partners
Tioma Therapeutics is an equal opportunity employer. We offer a chance to work with talented people in a collaborative environment and provide top-notch benefits including health insurance, paid time off, annual performance bonuses, stock options and much more.
If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year. To learn more about Tioma, please visit our website at https://www.tiomatherapeutics.com.
Please no phone calls, agencies or recruiters