Director, Discovery and CMC Program Management Full Time

About Third Arc Bio

Third Arc Bio is a VC-backed biotech company with a strong financial foundation, focused on discovering and developing breakthrough biologics in Oncology and Immunology. Our mission is to translate innovative science into transformative therapies that address critical unmet medical needs. With an experienced and agile team, we are rapidly advancing multiple biologics programs from discovery through IND submission and early clinical development.

Position Overview

We are seeking a highly motivated and results-driven Director, Discovery and CMC Program Management to lead and coordinate biologics programs across Discovery and CMC functions, working closely with internal teams and global external partners.

This role will be responsible for creating, aligning, and managing integrated development plans supporting rapid biologics advancement from early discovery through clinical manufacturing. The candidate will play a key role in accelerating timelines, driving cross-functional execution, and ensuring seamless transition from Discovery into Development and CMC activities.

The ideal candidate will have strong expertise in biologics discovery and phase-appropriate CMC development, including lead development, developability assessment, cell line development, process development, analytical development, manufacturing, regulatory support, and global CDMO management. This individual must possess excellent leadership, communication, organizational, and risk-management skills, with the ability to drive complex programs in a fast-paced biotech environment.

Reporting to the Senior Vice President, CMC, this role will play a critical part in supporting global biologics development activities, including programs supporting U.S. regulatory submissions and clinical trials.

Key Responsibilities

Discovery and Early Development Support

• Support biologics discovery and early development activities, including candidate evaluation, developability assessment, manufacturability assessment, and transition into development.
• Collaborate with Discovery scientists on sequence optimization, vector design strategies, expression approaches, and candidate selection.
• Coordinate early-stage activities related to research cell line generation and screening.
• Support integration of Discovery and CMC strategies to accelerate development timelines.

CMC Program Management

• Develop and manage integrated Discovery and CMC project plans aligned with corporate objectives, program milestones, and regulatory timelines.
• Lead and coordinate phase-appropriate biologics CMC activities across internal functions and external CDMOs/CROs.
• Drive execution of biologics development programs from cell line development through GMP manufacturing and clinical supply.
• Manage timelines, budgets, risks, dependencies, and resource planning across multiple programs simultaneously.
• Facilitate cross-functional coordination between Discovery, process development, analytical development, manufacturing, quality, regulatory, supply chain, and external partners.
• Establish and maintain strong relationships with global CDMOs and ensure alignment between internal and external project plans.
• Identify project risks proactively and develop mitigation and contingency plans to maintain aggressive timelines.
• Lead regular project meetings, including agenda preparation, action tracking, issue resolution, and follow-up activities.
• Support manufacturing and analytical strategies for biologics programs, including monoclonal antibodies, bispecifics, ADCs, and other complex biologics.
• Coordinate activities related to tech transfer, GMP manufacturing, release testing, stability, and regulatory documentation.
• Support preparation and submission of regulatory filings, including IND/IMPD-related CMC documentation.
• Develop dashboards, reports, and executive presentations to communicate program status, milestones, KPIs, and risks.
• Implement project management best practices, tools, and governance processes to improve operational efficiency.
• Promote a collaborative, transparent, and execution-focused team culture.
• Monitor project performance and recommend operational improvements to optimize speed, quality, and cost.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Biotechnology, Pharmacy, Molecular Biology, or related scientific discipline; advanced degree preferred.
• PMP certification or equivalent project management certification strongly preferred.
• Minimum 8+ years of experience in biologics Discovery, Development, or CMC operations within the biotechnology or pharmaceutical industry.
• Minimum 3+ years of experience leading complex cross-functional biologics programs.
• Strong understanding of biologics drug development, including: discovery support and developability assessment, cell line development, upstream and downstream process development, analytical development, drug substance and drug product manufacturing, tech transfer, GMP operations, regulatory filing support, experience managing external CDMOs and global biologics development programs, experience supporting biologics programs from Discovery through IND-enabling activities and early clinical development.
• Strong knowledge of biologics development timelines, regulatory expectations, and risk management strategies.
• Excellent organizational, analytical, and communication skills.
• Ability to work effectively in a fast-paced, virtual, and highly collaborative biotech environment.
• Proven ability to manage multiple priorities while maintaining attention to detail and execution quality.
• Strong interpersonal and leadership skills with the ability to influence across functions and organizational levels.
• Proficiency with project management tools and Microsoft Office applications.

Preferred Experience

• Experience with monoclonal antibodies, bispecific antibodies, ADCs, fusion proteins, or other complex biologics.
• Experience working in a virtual biotech environment utilizing global CDMO networks.
• Experience supporting accelerated development timelines from DNA to First-in-Human (FIH).
• Familiarity with U.S. FDA and global regulatory expectations for biologics development.

What We Offer

• Opportunity to play a key role in advancing innovative biologics therapies in Oncology and Immunology.
• Highly collaborative and entrepreneurial work environment.
• Exposure to cutting-edge biologics discovery and development programs.
• Competitive compensation package, including equity participation.
• Comprehensive benefits package.
• Professional growth opportunities within a rapidly growing biotech company.

How to Apply

Interested candidates should submit their resume and a cover letter outlining their relevant experience to careers@thirdarcbio.com.

Join Third Arc Bio and help shape the future of biologics innovation and patient care.