Director, CMC Project Management and Alliance ...

Director, CMC Project Management and Alliance ManagementJune 2025Position 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 ResponsibilitiesCMC Project ManagementDrive the overall planning, execution, and delivery of CMC activities for assigned drug development programs from candidate nomination through clinical developmentSupport 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 requirementsDevelop and maintain integrated CMC project plans, timelines, milestones and risk assessments covering drug substance, drug product, manufacturing and analytical development activitiesCoordinate CMC sub-team activities including Process Development, Analytical Development, Manufacturing, and Quality teams at CDMOsManage contracts, Purchase Orders (POs), invoices and logistics; track expenses; and support the finance team for budget planningEnsure CMC readiness for IND submissions, clinical trial material supply, and regulatory interactionsManage contract development and manufacturing organizations (CDMOs), track deliverables, and organize technical documents.Alliance ManagementServe as primary operational interface for strategic partnerships and business deals involving CMC activitiesCoordinate joint development activities with alliance partners, ensuring alignment on CMC strategies, timelines, and deliverablesFacilitate communication between internal teams and external partners regarding CMC development plans, progress, and issuesSupport alliance contracts and agreements by ensuring CMC-related terms and deliverables are clearly defined and executedManage technology transfer activities and knowledge sharing with business partnersTrack and report on alliance-related CMC milestones and performance metricsQualificationsBS/MS in Chemical Engineering, Chemistry, Biochemistry, or related life sciences field and PMP qualification preferred6+ years of experience in biotech/pharmaceutical CMC project management and alliance management. Experience in both Big Pharma and small biotech preferredDemonstrated experience in CMC project management for biologics development from early-stage through Phase 2, with deep understanding of:Biologics manufacturing processesAnalytical method development and validationRegulatory CMC requirementsTechnology transfer and manufacturing scale-upExperience managing relationships with CDMOs, CMOs, and analytical service providersTrack record of alliance management or partnership coordination in biotechnology/pharmaceutical industryStrong understanding of IP considerations, technology transfer, and collaborative development frameworksExperience in cross-functional collaboration within PDT settings and supporting PTLsUnderstanding of risk management and experience establishing mitigation strategies for manufacturing and supply chain risksExpertise 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 interactionsStrong organizational skills and attention to detailAbility to operate with a sense of urgency and flexibility in a fast-paced, dynamic environment and is comfortable with ambiguity and strategic changesCompany OverviewTCG 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 and CompensationTCG 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 with the Subject Heading: Staffing Agency Request. #J-18808-Ljbffr

Created: 2025-09-17