Manufacturing Associate Job at Kolon TissueGene, Inc. in Rockville

About the Company:

Kolon TissueGene, Inc. (KOSDAQ: 950160) is a trailblazer in the field of biopharmaceuticals, specializing in innovative regenerative medicine. With a global presence and an unwavering commitment to cutting-edge therapies, we are transforming patient care worldwide. As we enter an exciting phase of growth, we are building a world-class team to drive our mission forward and revolutionize the future of medicine. Join us at Kolon TissueGene, where you’ll be part of something truly impactful—advancing life-changing treatments and shaping the future of healthcare.

Job Purpose:

The Manufacturing Associate will play a critical role in supporting cGMP cell therapy manufacturing processes, providing hands-on technical support across a variety of functions, including technology transfer, process validation, and ongoing process optimization. You will collaborate with both internal teams and external Contract Manufacturing Organizations (CMOs) to ensure the successful delivery of high-quality products, on time and within budget. This is an excellent opportunity for someone with a passion for cell therapy and manufacturing to make a tangible impact on patient outcomes.

Duties and Responsibilities:

As a Manufacturing Associate at Kolon TissueGene, you will:

Specific Responsibilities:

• Review and monitor cell culture and aseptic processing activities at CDMOs (Contract Development and Manufacturing Organizations).
• Ensure compliance with cGMP and quality standards during GMP developmental and commercial manufacturing operations.
• Provide technical support to Quality Assurance (QA) teams for process discrepancies and deviation investigations.
• Coordinate and track GMP material shipments both domestically and internationally.
• Assist in planning, writing, and executing cGMP manufacturing protocols, batch records, SOPs/WIs, and plans.
• Prepare detailed manufacturing and campaign reports, ensuring accurate and timely documentation of all processes and data.
• Track cGMP material and cell bank inventories, ensuring integrity and compliance with required standards.
• Coordinate and track lot release testing samples.
• Provide technical support to CDMO GMP manufacturing activities as needed.
• Maintain product and cell bank inventories in a cGMP-compliant manner.

General Responsibilities:

• Act as a liaison between Kolon TissueGene’s functional groups and subcontractors.
• Report progress to supervisors and attend regular progress meetings.
• Stay informed about current and emerging technologies, contributing to the adoption of innovative approaches.
• Comply with KTG quality systems and safety policies.
• Familiarize yourself with aseptic processing techniques in a cleanroom setting.

Qualifications:

To thrive in this role, you will need:

• A BS or MS degree in Biology or a related discipline.
• 2-5 years of experience in biotechnology or pharmaceutical cGMP manufacturing, with specific exposure to cell culture, aseptic processing, and tissue culture using Flask, HyperStack, Cell Factory, or 3D cell culture.
• A strong background in upstream large molecule manufacturing and cell manufacturing is essential.
• Prior GMP experience is mandatory, with hands-on experience in cell therapy or biopharmaceutical manufacturing.
• Strong interpersonal and communication skills, with an emphasis on attention to detail and organizational excellence.
• Solid documentation (GDP) skills, ensuring that all processes and activities are meticulously recorded.
• Self-motivation and the ability to work both independently and in a collaborative team environment.
• Ability to manage multiple tasks effectively in a fast-paced, deadline-driven environment.
• Exceptional oral and written communication skills in English.
• Willingness to travel up to 20% of the time for on-site visits, including potential international travel.

Working Conditions:

This role will involve working in a mix of office settings, as well as at Contract Manufacturing Organizations (CMOs) and other partner/vendor facilities. Flexibility is important, as occasional non-standard work hours (e.g., evening or weekend work) may be required to support manufacturing campaigns.

Physical Requirements:

• Must be able to occasionally lift or carry up to 20 pounds.
• Must be able to engage in moderate-intensity physical activity for at least 30 minutes.
• Ability to sit or stand for extended periods.

Direct Reports:

This role does not have direct reports.

Compensation and Benefits:

• Competitive salary
• Comprehensive health and wellness benefits
• Opportunities for professional development and career growth within a dynamic, growing industry

Equal Opportunity Statement:

Kolon TissueGene is an equal opportunity employer committed to fostering a diverse and inclusive workplace. We embrace individuals of all backgrounds and are dedicated to providing equal employment opportunities to all employees and applicants. We encourage applications from all qualified individuals, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Kolon TissueGene is committed to supporting visa sponsorship for qualified candidates as needed.

J

oin Us:

At Kolon TissueGene, you’ll be part of an innovative company at the forefront of regenerative medicine. We value your expertise, and we’re eager to see the unique perspectives you bring to our team. Help us deliver transformative patient outcomes while advancing your career in a collaborative and diverse environment. We look forward to having you on our team!