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Senior Manager / Associate Director, Process Development

Department: CMC

Work Location: This is an on-site position based at our corporate Headquarters in South San Francisco, CA.

Position Summary:
TCG Labs Soleil is seeking a highly organized and experienced biologics CMC professional to join our CMC team as Senior Manager / Associate Director, Process Development. Reporting to the Senior Director, CMC Lead, this individual will help drive day-to-day execution of our expanding portfolio of CMC development programs. This role is ideal for someone who combines deep technical expertise in biologics drug substance or drug product process development/manufacturing with strong CMC project management skills. In this role you will be working closely with CDMOs and internal partners and will be responsible for providing technical oversight to ensure on-time delivery of clinical materials. The position offers significant growth opportunities in a fast-paced and highly collaborative startup environment.

Responsibilities:

Technical Leadership
Serve as key technical owner for at least one CMC functional area, either biologics drug substance (DS) or biologics drug product (DP) process development/manufacturing.
Candidates with DS background will lead downstream and/or upstream process development, scale-up, technology transfer, GMP drug substance manufacturing.
Candidates with DP background will lead formulation and drug-product manufacturing process development, aseptic fill-finish, lyophilization, clinical in-use studies and clinical supply.
Review technical documentation, including development reports, tech transfer protocols, SOPs, master and executed batch records. Support review of deviations, investigations, CAPAs, change controls, and root-cause analyses.
Support CMC regulatory submissions by reviewing or contributing to relevant IND/IMPD Module 3 sections.
Work closely with Quality Assurance and Regulatory Affairs to ensure CMC documentation, batch disposition readiness, and submission deliverables meet program, quality, and regulatory expectations.

CMC Operations
Manage day-to-day CMC operations, serving as the central coordinator across CMC, Quality Assurance, Regulatory Affairs, non-clinical, Clinical Operations, and external CDMO partners.
Develop, maintain, and drive integrated CMC project plans, GMP manufacturing timelines, process development and technology transfer deliverables, analytical and stability deliverables, QA review cycles, regulatory submission milestones, and clinical supply needs.
Facilitate CMC team meetings, including agenda preparation, meeting minutes, action tracking, decision documentation, and communication of key updates.
Track CMC budgets, CDMO invoices, purchase orders (PO), expenses and coordinate with finance team.
Maintain internal CMC databases and risk registers, prepare project updates and organize critical documents.
Drive alignment across key cross-functional milestones, ensuring manufacturing schedules, QA batch release timelines, regulatory submission needs, and clinical supply requirements are coordinated and visible.

Preferred Qualifications
B.S., M.S., or Ph.D. in biochemistry, biological sciences, biotechnology, chemical engineering, pharmaceutical sciences, or a related scientific discipline.
Minimum of 10(BS)/8(MS)/6(PhD) years of relevant biologics CMC experience. Demonstrated technical expertise in either biologics DS or DP process development/manufacturing. Strong downstream process development experience is highly desirable.
Experience managing external CDMOs, CROs, testing laboratories, or other CMC vendors.
Strong project management capability, including integrated timeline development, critical path management, action tracking, risk management, and cross-functional communication.
Experience supporting early-stage biologics development programs, including IND, IMPD, or other clinical-stage regulatory submissions.
Strong knowledge of GMP regulations, regulatory (FDA/EMA) and ICH guidelines.
Strong organizational skills and ability to manage multiple workstreams, vendors, priorities, and deadlines in a fast-paced environment.
Excellent written and verbal communication skills
Proficiency with Smartsheet, MS Project, Microsoft Teams, SharePoint, Veeva, or other project and document management systems. Familiarity with AI-enabled productivity tools highly desirable.

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.

For more details, visit TCGLSoleil.com and follow us on LinkedIn

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 Senior Manager/Associate Director role is $160,000 - $200,000 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.