Job Details

Location: South San Francisco, CA – Hybrid, with the ability to be in office 2-3 days per week

Position Summary:

Director/Senior Director of Chemistry, Manufacturing, and Controls (CMC) is responsible for leading and overseeing all aspects of the CMC function, ensuring the successful development, manufacturing, regulatory approval, and clinical supply of biopharmaceutical products. Reporting to the Chief Scientific Officer, this role involves strategic planning, cross-functional collaboration, and leadership to ensure the company's products are developed efficiently, meet regulatory standards, and are commercially viable.

Key Responsibilities include but are not limited to:

• Develop and implement the CMC strategy aligned with the company's overall goals and objectives
• Oversee the development and optimization of large molecule drug substance and drug product manufacturing processes for biopharmaceutical products
• Ensure the successful scale-up of processes from laboratory to clinical and commercial scale
• Lead efforts in process development, formulation development, analytical method development, process validation and drug supply
• Ensure all CMC activities comply with regulatory requirements (e.g., FDA, EMA) and industry standards
• Lead the preparation and submission of phase-appropriate CMC sections of regulatory filings, including INDs, and NDAs
• Ensure the timely and cost-effective production of clinical and commercial supplies
• Work with Quality to maintain quality system components to ensure product quality and compliance, including controlled documentation, change control, noncompliance/deviation management, CAPA, and training
• Collaborate with R&D, Quality, Regulatory Affairs, and other departments to ensure alignment and effective execution of CMC activities
• Work with internal and external partners to drive CMC objectives forward and provide oversight and tracking of critical pipeline objectives
• Work with Quality Assurance and Regulatory Affairs to maintain inspection readiness
• Work closely with clinical trial scientists to align CMC deliverables with clinical study requirements, including supply planning, product specifications, and regulatory documentation
• Participate in project teams and contribute to the overall product development strategy
• Help manage the CMC budget, ensuring clear oversight and efficient allocation of resources
• Identify and address resource needs, including personnel, equipment, and facilities

Required Qualifications:

• Advanced degree (Ph.D., M.S., or equivalent) in biochemistry, chemistry or cell biology technical field
• 10+ years of CMC experience in the biotech/pharmaceutical industry, including work with contract manufacturers, with 5+ years of direct experience in biologics drug design
• Deep understanding of the biotherapeutic drug discovery process
• Demonstrated track record of leadership advancing biologics projects through different stages of drug discovery and early-stage process and clinical development
• Experience managing US and International CMOs for the manufacture of drug substance and drug product
• Experience authoring/reviewing regulatory documents (IND, CTA, NDA) and FDA information requests, interfacing with regulatory agencies, and robust knowledge of relevant FDA and EMEA regulations and guidances
• Excellent written and verbal communication skills across multi-functional teams
• Proven hands-on leadership, project management and communication skills (written and verbal)
• Team player who is able to work and collaborate effectively with internal stakeholders as well as external contract organizations

Compensation: $240,000 - $290,000, plus Discretionary Bonus.

TRexBio is a clinical stage biotechnology company leveraging cutting edge computational biology tools, a focus on human tissue, and expertise in immunobiology to develop revolutionary therapeutics for inflammatory diseases. Our powerful ‘deep biology' discovery engine maps human tissue Treg behavior to disease processes, allowing us to identify and characterize novel targets for therapeutic intervention. Leveraging this platform, we are building a broad portfolio of novel therapies that modulate the immune system to restore human tissue immune homeostasis.

Our Culture:

At TRexBio, you will have the opportunity to work with amazingly smart humans who strive to make the world a better place. In addition to our team-centric culture, we believe that your individual creativity will help us to be our best. Our staff happy hours, organized by our Culture Club, bring us all together in creative and social activities. Our colleagues admire and respect one another. We celebrate our wins, update company news and acknowledge each other's achievement weekly and monthly at all company meetings that celebrate our work and our people.

TRexBio is proud to be an AA/EEO employer and all qualified candidates will receive consideration without regard to characteristics protected by applicable local, state, or federal law, such as race, color, sex, age, religion, national origin, physical or mental disability, pregnancy, marital status, veteran or military status, genetic information, or sexual orientation.