Senior Manufacturing Process Engineer Position Available In Durham, North Carolina

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 c

GMP , 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.