Director, CMC, Process Development and Manufacturing

Job Type: Full-time

Description: Director, CMC, Drug Substance – Process Development & Manufacturing 

Location: Hybrid/Remote

About GondolaBio 

GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. 

Position Overview:

The Director, CMC – Drug Substance Process Development and Manufacturing will provide strategic and technical leadership for synthetic oligonucleotide (ASO and siRNA) drug substance development and manufacturing across the company’s pipeline.

Reporting to the VP, CMC Oligonucleotides, this role will own the end-to-end DS CMC strategy, from early development through late-stage clinical and commercial readiness. The successful candidate will lead process design, development, scale-up, and manufacturing execution, working closely with internal cross-functional teams and external CDMOs to ensure robust, scalable, and regulatorily compliant processes.

This is a highly visible leadership role requiring deep expertise in solid-phase oligonucleotide synthesis, purification, control strategy, technology transfer, and lifecycle management to support IND, NDA, and commercial submissions.

Key Responsibilities

Drug Substance Strategy & Leadership

· Develop and execute drug substance CMC strategies for synthetic oligonucleotide (ASO and siRNA) programs across all stages of development.

· Provide scientific and technical leadership for process development, manufacturing, and scale-up, ensuring alignment with program timelines and regulatory expectations.

· Serve as the DS subject matter expert within cross-functional program teams.

Process Development & Scale-Up

· Lead process design and optimization for oligonucleotide drug substance manufacturing, including all the unit operation of solid-phase synthesis, deprotection and cleavage, purification (chromatography and alternative methods), concentration, desalting, and formulation-ready DS preparation

· Define scalable manufacturing approaches and process characterization strategies.

· Establish process control strategies, in-process controls, and critical quality attributes (CQAs).

Manufacturing & CDMO Management

· Oversee external CDMO activities, including process development, GMP manufacturing, scale-up, and technology transfer.

· Serve as the primary technical interface with CDMOs, ensuring: high-quality execution, on-time delivery, and budget and scope control

· Review and approve development reports, batch records, manufacturing protocols, deviations, and investigations.

Regulatory & CMC Documentation

· Author, review, and approve drug substance sections of regulatory submissions (IND, IMPD and NDA).

· Support regulatory interactions related to DS manufacturing, control strategies, and comparability.

· Ensure DS activities meet cGMP, ICH, and global regulatory requirements.

Late-Stage & Commercial Readiness

· Lead process validation, PPQ planning, and commercial manufacturing readiness.

· Develop and execute lifecycle management and continuous improvement strategies.

· Support supply chain robustness and long-term manufacturing strategies.

People & Team Leadership

· Build, mentor, and manage a high-performing drug substance CMC team.

· Foster a collaborative, science-driven culture focused on accountability, transparency, and execution excellence.

· Provide technical coaching and career development for DS scientists and engineers.

Qualifications & Experience

· Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline (MS/BS with significant industry experience considered). 

· Typically 10+ years of industry experience in drug substance development and manufacturing. 

· Deep hands-on expertise in synthetic oligonucleotide (ASO and/or siRNA) process development. 

· Demonstrated success advancing DS programs from early development through clinical and/or commercial stages. 

· Strong experience with synthetic oligonucleotides unit operations, including solid-phase oligonucleotide synthesis, purification and downstream processing, and GMP manufacturing and technology transfer

· Proven ability to manage external CDMOs and complex project timelines. 

· Solid understanding of cGMP, ICH guidelines, and global regulatory expectations for oligonucleotide therapeutics. 

· Excellent leadership, communication, and cross-functional collaboration skills. 

· Comfortable operating in a fast-paced, high-accountability biotech environment. 

· Willingness to travel and work across global time zones as needed.

What We Offer 

· Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts 

· A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak 

· An unyielding commitment to always putting patients first.  

· A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science 

· A place where you own the vision – both for your program and your own career path 

· A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game 

· Access to learning and development resources to help you get in the best professional shape of your life 

· Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs) 

· Flexible PTO 

· Rapid career advancement for strong performers 

· Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time  

· Partnerships with leading institutions 

· Commitment to Diversity, Equity & Inclusion 

The base pay range for this position is $220,000 to $250,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.