Senior Associate, Process Development

ABOUT KOLON TISSUEGENE

Kolon TissueGene, Inc. (KTG) is a clinical-stage biopharmaceutical company developing TG-C, a first-in-class cell and gene therapy for osteoarthritis — a disease with significant unmet need and no approved disease-modifying treatment in the U.S. We are a small, high-conviction team preparing for our most pivotal chapter: commercial launch. Every person we hire shapes how we get there.

ABOUT THE ROLE

The Senior Process Development Associate will independently design, execute, and document process development studies that support our clinical manufacturing programs. This role requires hands-on laboratory experience and the ability to plan, execute, analyze, and document PD activities with minimal supervision.

This is not a manufacturing technician role, and it is not an entry-level PD position. We're looking for someone who can run projects independently and contribute meaningfully to protocol development, batch records, and process optimization — bringing both technical depth and ownership to everything they do.

WHAT YOU WILL DO

• Independently design and execute process development studies, including experimental plans, study protocols, and batch records
• Perform and oversee scale-up or scale-out studies, process optimization runs, and special/non-routine PD runs
• Analyze and interpret experimental data with scientific rigor
• Review results, troubleshoot issues, and recommend process improvements to enhance robustness and efficiency
• Contribute to documentation packages with accuracy and attention to detail
• Collaborate cross-functionally with Manufacturing, Analytical Development, and Research; maintain compliance with GMP expectations where applicable

WHAT WE ARE LOOKING FOR

REQUIRED

• Bachelor’s degree required, with a strong preference for a STEM field; laboratory coursework and hands-on lab training required.
• 3–5 years of relevant Process Development or closely related experience — this role requires independent PD capability, not entry-level lab support.
• Demonstrated experience independently designing PD studies, executing experiments, and reviewing and interpreting data.
• Strong hands-on laboratory experience with a solid grounding in cell culture techniques and core PD laboratory methods.
• Upstream processing experience required.
• Experience generating and maintaining technical documentation (experimental plans, protocols, batch records, reports).

PREFERRED

• GMP manufacturing exposure.
• Biologics experience.
• Cell therapy or gene therapy experience (preferred but not mandatory).
• Downstream processing experience — a strong plus.
• Broader exposure beyond a single modality.

WHY KTG

First-in-Class Science TG-C is a cell and gene therapy advancing toward U.S. commercialization for osteoarthritis — a disease with no approved disease-modifying treatment. Your work in the lab directly supports a potential paradigm shift in how this condition is treated.

Real Ownership You will run your own studies end-to-end — from experimental design through documentation — with the autonomy that comes from being trusted to deliver.

Direct Access to Leadership On a small, mission-driven team, you will work closely with PD leadership, Manufacturing, Analytical Development, and Research — with no layers between your work and the program's direction.

Culture of Rigor & Curiosity We value deep scientific thinking, intellectual honesty, and continuous improvement, and we invest in the tools and training to help you grow your expertise.

BENEFITS

• Onsite yet flexible work schedules
• Premium-free global health insurance (50% dependent coverage)
• 401k with immediate eligibility
• Long-term incentive bonuses
• On-site gym & wellness perks
• Extra PTO accrual every year
• Global and local training opportunities

WORK ENVIRONMENT

This is a full-time, onsite role based at our Rockville, MD headquarters. Work is performed in a general and biological laboratory environment; proper gowning and PPE (lab coat, safety glasses, gloves, hair and shoe covers) are required where applicable.

PHYSICAL REQUIREMENTS

Ability to sit for extended periods at a computer workstation.

Extensive keyboarding involving repetitive finger motion.

Ability to communicate via telephone and video conference.

Ability to lift, push, or carry up to 25 lbs occasionally.

DISABILITY ACCOMMODATION & VETERAN SELF-IDENTIFICATION

We invite all applicants to voluntarily self-identify as a person with a disability and/or a protected veteran. This information is collected for federal compliance purposes only and will not affect hiring decisions. To request a reasonable accommodation at any stage of the application or interview process, contact us at hr@tissuegene.com. All requests are handled confidentially and in accordance with applicable law.

Kolon TissueGene, Inc. is an equal opportunity employer.

We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration without regard to race, color, religion, gender, identity, sexual orientation, national origin, disability, or veteran status.