Job Details

Job Title: Manufacturing and Process Development Associate

Location: PranaX, 6420 Levit Green Blvd, Suite 220, Houston, TX 77021

Employment Type: Full-Time

Job Summary:

PranaX is seeking a skilled and proactive Manufacturing and Process Development Associate to join our pioneering team in regenerative medicine. This role is designed for a professional with 4+ years of experience in manufacturing and process development, offering an exciting opportunity to contribute to the optimization and scale-up of stem cell-derived exosome manufacturing processes for wellness applications. Working under the direction of senior team members, you will leverage your hands-on experience to conduct experiments, operate specialized equipment, and support research efforts in a GMP-compliant environment. This position is ideal for someone with a solid foundation in bioprocessing or process development who is eager to advance their career by contributing to innovative therapies at a visionary company.

Key Responsibilities:

• Process Development: Support the design and execution of experiments to optimize manufacturing processes for stem cell-derived exosomes, ensuring scalability and consistency for wellness applications.
• Clean Room Operations: Operate and maintain specialized equipment for exosome isolation, purification, and characterization, troubleshooting issues to ensure reliable performance in a GMP manufacturing suite. Maintain a clean and organized biosafety cabinet and clean room environment, adhering to safety and contamination control protocols and aseptic processing tasks, i.e., vial filling.
• Experimentation: Conduct small- to medium-scale experiments to refine process parameters, producing GMP-compliant exosome batches and analyzing results to improve yield, purity, and functionality.
• Research: Design studies, collect and analyze data, and contribute to the development of exosome-based therapies, focusing on their regenerative potential.
• Documentation: Author, revise, and review Standard Operating Procedures (SOPs), batch records, and technical reports, ensuring accuracy and compliance with GMP standards.
• Validation Support: Participate in the qualification and validation of equipment and processes, applying knowledge of cGMP guidelines to ensure regulatory compliance.
• Data Analysis: Analyze experimental and process data using analytical tools, providing insights to optimize manufacturing workflows and presenting findings to cross-functional teams.
• Technology Transfer: Assist in the execution of process development and technology transfer activities, ensuring quality and consistency during scale-up efforts.
• Lab Maintenance: Support the upkeep of laboratory equipment and manufacturing systems, contributing to a safe and efficient work environment.
• Continuous Improvement: Stay informed on advancements in exosome research and manufacturing technologies, proposing process enhancements and participating in team discussions to drive innovation.
• Team Collaboration: Work closely with colleagues across departments, sharing technical expertise and communicating results effectively to advance project goals.
• Additional Duties: Take on additional responsibilities as needed to support the Manufacturing and Process Development team's objectives.

Qualifications:

• Education: Bachelor's Degree in Chemical Engineering, Biology, Biochemistry, Molecular Biology, Biotechnology, or a related field. A recent PhD in a relevant discipline may substitute for some experience.
• Experience: 4 years of hands-on experience in manufacturing and process development within a biotech, pharmaceutical, or related industry setting. Experience with bioprocessing, process optimization, or GMP environments is highly preferred.
• Technical Skills:
• Working knowledge of bioprocessing techniques such as cell culture, purification (e.g., centrifugation, filtration, chromatography), or analytical methods.
• Familiarity with operating and troubleshooting manufacturing equipment in a controlled environment.
• Experience with aseptic processing and clean room operations is a plus.
• Process Development Expertise: Proven ability to contribute to process optimization and scale-up efforts, ideally with exposure to exosome or nanoparticle production.
• Analytical Abilities: Proficiency in experimental design and data analysis using tools like Excel, MATLAB, or statistical software to evaluate process performance.
• Technical Writing: Demonstrated experience drafting and revising SOPs, batch records, or technical documentation with attention to detail and regulatory compliance.
• Regulatory Knowledge: Solid understanding of GMP principles and regulatory standards (e.g., FDA guidelines), with experience applying them in a manufacturing context.
• Problem-Solving: Strong technical problem-solving skills, with the ability to identify issues and propose practical solutions based on prior experience.
• Research Interest: Passion for scientific research and a proactive approach to advancing regenerative medicine through process development.
• Detail-Oriented: Commitment to quality, safety, and compliance, with strong organizational skills to manage multiple tasks effectively.
• Communication: Excellent verbal and written communication skills, with the ability to collaborate in a team-oriented environment and present findings clearly.

Why Join PranaX?

This role offers a chance to grow your career at the cutting edge of regenerative medicine. You'll apply your manufacturing and process development experience to impactful projects, collaborate with industry leaders, and help shape innovative wellness products that could transform lives globally—all within a dynamic and supportive team.