Director, CMC Project Management and Alliance Management

Make sure to apply with all the requested information, as laid out in the job overview below. June 2025 Position Summary: TCG Labs-Soleil is looking for a Director, CMC Project Management and Alliance Management who will report to the VP of CMC. This individual will coordinate and operationally manage CMC development programs and strategic partnerships, ensuring timely execution of CMC activities while managing critical business and alliance relationships. The ideal candidate is a proactive, organized and adaptable operator with a proven track record in biologics CMC development, alliance management experience, excellent communication skills, and the ability to thrive in a fast-paced, collaborative environment. Key Responsibilities CMC Project Management Drive the overall planning, execution, and delivery of CMC activities for assigned drug development programs from candidate nomination through clinical development Support CMC leads and Project Team Leaders (PTLs) on cross-functional Project Development Teams (PDTs) with specialized focus on CMC deliverables including process development, analytical method development, manufacturing strategy, and regulatory CMC requirements Develop and maintain integrated CMC project plans, timelines, milestones and risk assessments covering drug substance, drug product, manufacturing and analytical development activities Coordinate CMC sub-team activities including Process Development, Analytical Development, Manufacturing, and Quality teams at CDMOs Manage contracts, Purchase Orders (POs), invoices and logistics; track expenses; and support the finance team for budget planning Ensure CMC readiness for IND submissions, clinical trial material supply, and regulatory interactions Manage contract development and manufacturing organizations (CDMOs), track deliverables, and organize technical documents. Alliance Management Serve as primary operational interface for strategic partnerships and business deals involving CMC activities Coordinate joint development activities with alliance partners, ensuring alignment on CMC strategies, timelines, and deliverables Facilitate communication between internal teams and external partners regarding CMC development plans, progress, and issues Support alliance contracts and agreements by ensuring CMC-related terms and deliverables are clearly defined and executed Manage technology transfer activities and knowledge sharing with business partners Track and report on alliance-related CMC milestones and performance metrics

Qualifications BS/MS in Chemical Engineering, Chemistry, Biochemistry, or related life sciences field and PMP qualification preferred 6+ years of experience in biotech/pharmaceutical CMC project management and alliance management. Experience in both Big Pharma and small biotech preferred Demonstrated experience in CMC project management for biologics development from early-stage through Phase 2, with deep understanding of: Biologics manufacturing processes Analytical method development and validation Regulatory CMC requirements Technology transfer and manufacturing scale-up

Experience managing relationships with CDMOs, CMOs, and analytical service providers Track record of alliance management or partnership coordination in biotechnology/pharmaceutical industry Strong understanding of IP considerations, technology transfer, and collaborative development frameworks Experience in cross-functional collaboration within PDT settings and supporting PTLs Understanding of risk management and experience establishing mitigation strategies for manufacturing and supply chain risks Expertise in the use of modern project management tools (Gantt charts, risk logs) and technologies (Smartsheet, Excel, PowerPoint, ThinkCell) Ability to be onsite, particularly during PDT meetings and alliance partner interactions Strong organizational skills and attention to detail Ability to operate with a sense of urgency and flexibility in a fast-paced, dynamic environment and is comfortable with ambiguity and strategic changes 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. 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 the Director role is $161,000 - $287,500 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. 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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