Director / Senior Director, CMC Lead

Director / Senior Director, CMC Lead

August 2025

Department / Function : CMC / CMC Lead

Work Location : Corporate Headquarters (South San Francisco)

Position Summary :

TCG Labs-Soleil is looking for a top-notch CMC Lead to join our CMC team. We are seeking a highly skilled and self-motivated professional to lead and oversee cell line development, process development, analytical, formulation, technology transfer and manufacturing activities for our expanding portfolio of development programs. In this exciting leadership role, you’ll be working closely with CDMOs to develop fast and efficient plans for both upstream and downstream process development, analytical development, formulation, and facilitate the transfer of laboratory-scale processes to full-scale manufacturing. As the primary point of contact, you will be responsible for providing general oversight and technical guidance for CMC development, GMP production of drug substance (DS) and drug product (DP), product release and product stability monitoring, and regulatory submissions. In collaboration with cross-functional teams at TCG Labs-Soleil, you will play a key role in ensuring CMC timelines, mitigation of overall CMC development and manufacturing risk and the on-time delivery of clinical materials.

Responsibilities :

• Provide technical oversight for all CMC-related activities, including cell line, upstream and downstream process development, analytical method development and qualification, formulation development, reference standard generation and characterization, product stability evaluation, and scale-up, technology transfer, non-GMP and GMP productions, and batch dispositions
• Work closely with CDMOs and CMC project manager to ensure the overall CMC timelines and serving as the primary on-site resource during GMP manufacturing operations, to provide oversight and immediate troubleshooting support so that production-related issues are addressed promptly and delays or product quality deviation is avoided
• Collaborate with our Quality and Regulatory teams to ensure that all production activities are carried out according to established GMP standards and regulatory requirements
• Analyze production data, review protocols and technical reports, test methods, batch records and deviations and support batch disposition
• Work with our Supply Chain and Clinical Development teams to accurately project program-specific requirements for clinical supply, schedule manufacturing slots and organize delivery of clinical materials
• Actively participate in CDMO selection process and provide technical assessment of manufacturing capabilities
• Work with our CMC Regulatory team to prepare and review CMC sections of documents for submission to regulatory agencies

Qualifications :

Company Overview TCG Labs-Soleil, established in partnership with The Column Group , a science-focused venture capital firm, is pioneering a novel ‘venture capital-biotech’ model. Our core mission is to efficiently translate scientific insights into therapeutic solutions for patients facing serious diseases. This model supports scientific entrepreneurs from the initial idea to clinical proof of concept (PoC) by combining a dedicated fund (TCG Labs) with our independent, evergreen R&D center led by a top-tier scientific team (Soleil). Together, we create an integrated ecosystem that fosters the development of single-asset portfolio companies, strategically poised for transacting after clinical PoC.

EEO Statement TCG Labs-Soleil is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity / gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation can be directed to contact@tcglsoleil.com.

Benefits and Compensation TCG Labs-Soleil provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short and Long Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), 401k plan and PTO.

The anticipated salary range for fully qualified candidates applying for this role will be $168,000 - $356,250 annually (not including discretionary bonus, equity, and benefits). The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity.

Staffing Agencies TCG Labs-Soleil does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn’t have a signed agreement with TCG Labs-Soleil. Please do not send agency CVs / resumes through TCG Labs-Soleil website or TCG Labs-Soleil Employees. Inquiries must be sent to contact@tcglsoleil.com with the Subject Heading : Staffing Agency Request.

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