Job Description

Job Title: Manufacturing Process Engineer – Cell Therapy MS&T

Location: Durham, NC (Fully Onsite, 5 Days/Week)

Start Date: ASAP

Hours/Week: 40

Position Overview:

A leading cell therapy program is seeking a highly motivated Manufacturing Process Engineer to join its Manufacturing Science and Technology (MS&T) team. This individual will play a critical role in supporting late-stage manufacturing , process performance qualification (PPQ) readiness, and tech transfer activities for an autologous cell therapy product. The ideal candidate will bring a solid foundation in GMP operations , process control strategy , and risk-based assessments , serving as a technical subject matter expert (SME) to ensure process robustness, compliance, and continuous improvement across cross-functional teams.

Key Responsibilities:

• Develop and implement process control strategies for late-stage cell therapy drug product manufacturing.
• Monitor and analyze process performance data to ensure consistency and PPQ readiness.
• Collaborate with process development and manufacturing teams to execute tech transfer and support late-phase deliverables.
• Prepare and execute PPQ support protocols such as buffer stability and intermediate hold time studies; author corresponding summary reports.
• Participate in risk assessments , including Extractables & Leachables (E&L) studies and consumables qualification .
• Support the selection and justification of single-use systems and sterile processing equipment .
• Review and follow SOPs and work instructions related to manufacturing readiness and equipment qualification.
• Represent MS&T in cross-functional deviation investigations , conducting root cause analysis and proposing data-driven corrective actions.
• Ensure all activities are compliant with cGMP , FDA , ICH , and internal quality guidelines.
• Actively engage with cross-functional teams to align on regulatory, quality, and operational expectations.

Qualifications:

• Bachelor’s or advanced degree in Biology , Biochemistry , Chemical Engineering , or related field.
• 7–10 years of hands-on experience in MS&T or manufacturing engineering within a GMP-regulated cell/gene therapy environment.
• Strong understanding of PPQ , process validation lifecycle , and global regulatory requirements.
• Demonstrated expertise in late-stage tech transfer and process implementation .
• Proficiency in risk management , E&L analysis , and single-use systems is highly desirable.
• Skilled in interpreting SOPs, authoring technical protocols, and generating validation documentation.
• Excellent communication and collaboration skills, with the ability to work independently and across multidisciplinary teams.

Job Tags

Similar Jobs