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About the Role

TCG Labs Soleil is seeking a highly organized and experienced biologics CMC professional to join our CMC team. This individual will drive day-to-day execution of our expanding portfolio of CMC development programs, combining deep technical expertise in biologics drug substance or drug product process development/manufacturing with strong CMC project management skills. You will work closely with CDMOs and internal partners, providing technical oversight to ensure on-time delivery of clinical materials in a fast-paced, collaborative startup environment.

Responsibilities

Serve as key technical owner for biologics drug substance (DS) or biologics drug product (DP) process development/manufacturing.
Lead downstream and/or upstream process development, scale-up, technology transfer, and GMP drug substance manufacturing (for DS candidates).
Lead formulation and drug-product manufacturing process development, aseptic fill-finish, lyophilization, and clinical in-use studies (for DP candidates).
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 expectations.
Manage day-to-day CMC operations, coordinating 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), and expenses, coordinating with the 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.

Requirements

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.

Skills

Biologics drug substance process development
Biologics drug product process development
Manufacturing
CMC project management
Downstream process development
Upstream process development
Scale-up
Technology transfer
GMP drug substance manufacturing
Formulation
Drug-product manufacturing process development
Aseptic fill-finish
Lyophilization
Clinical in-use studies
Clinical supply
Technical documentation review
Regulatory submissions (IND/IMPD Module 3)
Quality Assurance
Regulatory Affairs
Project planning
GMP manufacturing timelines
Analytical deliverables
Stability deliverables
QA review cycles
Regulatory submission milestones
Clinical supply needs
Team meeting facilitation
Budget tracking
CDMO invoice management
Purchase order management
Expense tracking
Internal CMC database maintenance
Risk register maintenance
Project updates preparation
Document organization
Cross-functional milestone alignment
Manufacturing schedule coordination
QA batch release timeline coordination
Regulatory submission need coordination
Clinical supply requirement coordination
Smartsheet proficiency
MS Project proficiency
Microsoft Teams proficiency
SharePoint proficiency
Veeva proficiency
Project management systems
Document management systems
AI-enabled productivity tools

Location

South San Francisco, CA

Work Type

On-site
Full-time

Experience Level

Senior Manager
Associate Director
10+ years (BS)
8+ years (MS)
6+ years (PhD)

Education Level

B.S.
M.S.
Ph.D.

Salary/Compensations

$160,000 - $200,000 annually

Benefits

Medical Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short Term Disability
Long Term Disability
Health Savings Account (HSA)
Flexible Spending Accounts (FSA)
401k plan
PTO

About the Company

TCG Labs-Soleil, established in partnership with The Column Group, 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.

Equal Opportunity

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.