Director / Senior Director, CMC Process Development & Manufacturing

Valid8 Financial, Inc.; San Francisco (CA); On-site; USD 174,000 - 375,000; Full time

Job summary

An innovative firm is seeking a seasoned CMC manufacturing specialist to lead process development and oversee manufacturing activities. In this pivotal role, you will collaborate with cross-functional teams to ensure timely delivery of clinical materials while maintaining high standards of quality and compliance. Your expertise in biologics and strong leadership skills will be crucial in navigating the complexities of drug substance and product manufacturing. Join a dynamic team dedicated to translating scientific insights into therapeutic solutions, and be part of a pioneering venture that supports scientific entrepreneurs through the entire development process.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Short and Long Term Disability

Health Savings Account (HSA)

Flexible Spending Accounts (FSA)

401k plan

Paid Time Off (PTO)

Qualifications

• 10+ years in biologics CMC or biotech manufacturing.
• Strong knowledge of GMP regulations and CMC guidelines.
• Ability to travel domestically and internationally as needed.

Responsibilities

• Oversee process development and technology transfer for drug substance and product.
• Provide technical support during GMP manufacturing operations.
• Collaborate with Quality and Regulatory teams to ensure compliance.

Skills

Biologics CMC

Process Development

GMP Regulations

Troubleshooting

Communication Skills

Project Management

Education

MS or PhD in Chemistry

MS or PhD in Chemical Engineering

MS or PhD in Biochemistry

MS or PhD in Biotechnology

Job description

Director / Senior Director, CMC Process Development & Manufacturing
March 2025
Department / Function: IND-enabling / CMC
Work Location: Corporate Headquarters (South San Francisco)

Position Summary:
TCG Labs-Soleil is looking for a top-notch CMC manufacturing specialist to join our CMC team. We are seeking a highly skilled and self-motivated professional to lead and oversee process development, 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, 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 GMP production of drug substance (DS) and drug product (DP). In collaboration with cross-functional teams at TCG Labs-Soleil, you will play a key role in ensuring production timelines, mitigation of manufacturing risk and the on-time delivery of clinical materials.

Responsibilities:

1. Provide technical oversight for all manufacturing-related activities, including process development and scale-up, technology transfer, non-GMP and GMP productions, and CDMO technical support.
2. Work closely with CDMOs to ensure production timelines and serve 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 deviations are avoided.
3. Collaborate with our Quality and Regulatory teams to ensure that all production activities are carried out according to established GMP standards and regulatory requirements.
4. Analyze production data, review technical reports, batch records and deviations, and support batch disposition.
5. 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.
6. Actively participate in the CDMO selection process and provide technical assessment of manufacturing capabilities.
7. Work with our CMC Regulatory team to prepare and review CMC sections of documents for submission to regulatory agencies.

Qualifications:

1. Education: MS or PhD in Chemistry, Chemical Engineering, Biochemistry, Biotechnology, or related field.
2. Experience: 10+ years’ experience in biologics CMC or pharmaceutical/biotech manufacturing with a deep understanding of both DS and DP processes; hands-on experience in troubleshooting and problem-solving for biologics DS manufacturing is essential.
3. Knowledge of drug substance and drug product process development with work experience in both upstream and downstream aspects of drug substance development and production.
4. Solid understanding of CDMO capabilities and limitations and in-depth knowledge of clinical DS and DP operations; experience working with or in a contract manufacturing environment and an ability to effectively work either remotely or on location with external CDMOs to meet timelines while staying within approved budgets.
5. Ability to travel to 10-20% domestic and international sites as required.
6. Strong knowledge of GMP regulations and CMC-related regulatory guidelines.
7. Ability to work independently and effectively in a dynamic, fast-paced, collaborative environment as a member of a cross-functional team.
8. Exceptional verbal and written communication skills, including the ability to interact effectively with senior management, colleagues, and external collaborators.

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.

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 $174,300 - $375,000 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.