Process Development Scientist

Signature Biologics; Fort Worth, Arlington, Dallas (TX, TX, TX); On-site; USD 120,000 - 170,000; Full time

Job summary

Signature Biologics, LLC is seeking a Process Development Scientist to design, optimize, and scale processes for cellular therapeutics and biologics at our Dallas–Fort Worth on-site facility.

You will plan and execute laboratory experiments, analyze data for process robustness, and support technology transfer from development to GMP manufacturing. Collaboration with manufacturing, quality, and engineering is essential for regulatory compliance and continuous improvement.

Qualifications

• Experience with technology transfer from development to GMP manufacturing.
• Hands-on cell culture and biologics processing.
• GMP familiarity with regulatory documentation and quality systems.
• Background in bioprocess development and scale-up.

Responsibilities

• Design, optimize, and scale processes for cellular therapeutics and biologics.
• Plan and execute laboratory experiments and analyze data to improve robustness.
• Support technology transfer from development to GMP manufacturing.
• Document protocols and write reports; maintain compliant records.
• Contribute to continuous improvement initiatives within the facility.

Skills

Technology Transfer

Laboratory Skills

Data analysis

GMP knowledge

Communication

Education

Bachelor's in Biotechnology

Chemical Engineering or related engineering

Biochemistry

Tools

Data visualization software

Statistical software

Job description

Company Description

Signature Biologics is a cutting-edge development and GMP manufacturing facility specializing in cellular therapeutics and biologics. The organization focuses on using innovative techniques to manufacture human cellular and biologic products that are rigorously validated through scientific and clinical study. Signature Biologics provides best-in-class development and manufacturing capabilities to support therapies that enhance patients’ lives. Guided by decades of international leadership, the company aims to be a premier, trusted global source for cellular and biologic therapeutic solutions. Its work is characterized by stringent manufacturing standards and a commitment to advancing patient-centered innovations.

Role Description

The Process Development Scientist is a full-time, on-site role based in the Dallas–Fort Worth Metroplex. This position is responsible for designing, optimizing, and scaling processes for the development and manufacturing of cellular therapeutics and biologics. Day-to-day activities include planning and executing laboratory experiments, analyzing data to improve process robustness, and supporting technology transfer from development to GMP manufacturing. The role collaborates closely with cross-functional teams, including manufacturing, quality, and engineering, to ensure processes meet regulatory, safety, and quality requirements. The Process Development Scientist also contributes to documentation, protocol and report writing, and continuous improvement initiatives within the facility.

Qualifications

• Candidates should possess strong Technology Transfer skills, including experience transitioning processes from development to GMP manufacturing environments.
• Candidates should possess advanced Laboratory Skills and hands-on experience with cell culture, biologics processing, and relevant analytical techniques.
• Candidates should possess expertise in Good Manufacturing Practice (GMP), with familiarity in regulatory guidelines, documentation, and quality systems.
• Candidates should possess a foundation in Chemical Engineering or related engineering disciplines relevant to bioprocess development and scale-up.
• Candidates should possess proficiency in Data Analysis, including statistical methods, process characterization, and use of software tools for data visualization.
• Additional qualifications that would be beneficial include a graduate or bachelor’s degree in biotechnology, chemical engineering, biochemistry, or a related field; experience in cell therapy or biologics manufacturing; strong problem-solving and troubleshooting abilities; effective written and verbal communication skills; and the ability to work collaboratively in a multidisciplinary team.