Position Title: Senior Process Engineer

Location: Durham, NC

Reports To: Head of Delivery

Tune Therapeutics is a cutting-edge biotechnology company founded by world-class leaders in epigenome editing. At Tune, we strive to develop paradigm-changing cell and gene therapies that leverage epigenetic programming for the treatment of devastating diseases. We are building a highly skilled and dynamic team with expertise that spans drug discovery through commercialization. We are passionate about the science of epigenetic editing and its potential to transform patient care.

POSITION OVERVIEW

The Senior Upstream Process Engineer will be responsible for the development, optimization, scale-up, and technology transfer of upstream processes supporting fed batch e coli fermentation, DNA production, and mRNA in vitro transcription (IVT) bioreactor operations for GMP manufacturing. This role will focus on establishing scaled down processes for in-house process development and translating processes into scalable, reproducible, and compliant manufacturing operations, supporting clinical and commercial programs. The ideal candidate brings deep technical expertise in microbial fermentation and enzymatic processes, strong process understanding, and experience supporting GMP tech transfer and manufacturing readiness.

The Senior Process Engineer role is an on-site, lab-based role that does not support remote work.

KEY RESPONSIBILITIES

Upstream Process Development & Optimization

• Develop and optimize upstream processes for plasmid DNA production, mRNA IVT reactions, including cell culture, fermentation, and enzymatic transcription steps
• Design and execute bioreactor experiments to improve yield, productivity, robustness, and scalability
• Establish process parameter ranges, critical process parameters (CPPs), and control strategies based on data-driven process understanding
• Support scale-up activities from bench to pilot and manufacturing scale

Technology Transfer & GMP Support

• Lead and support technology transfer of upstream processes to GMP manufacturing and/or external CDMOs
• Author and review tech transfer documentation, batch records, process descriptions, and development reports
• Provide on-site or remote manufacturing support during engineering, GMP, and validation PPQ runs
• Troubleshoot process deviations and drive root cause investigations and continuous improvement initiatives

Process Characterization & Lifecycle Management

• Contribute to process characterization studies, including DoE-based evaluations to define operating ranges and process robustness
• Support development of phase-appropriate control strategies aligned with regulatory expectations
• Maintain process knowledge throughout the product lifecycle, incorporating process improvements while ensuring comparability

Cross Functional Collaboration

• Partner closely with cross-functional stakeholders to ensure integrated CMC strategies.
• Support preparation of CMC sections for IND/CTA/BLA/MAA submissions, including upstream process descriptions and justifications
• Work collaboratively with supply chain and manufacturing teams to ensure operational readiness and scalability

QUALIFICATIONS & EXPERIENCE

• BS, MS, or PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related discipline
• Desired industry experience in upstream process development or manufacturing support for biologics or nucleic acid therapeutics varies based on education level: PhD and 3-5 years, MS and 5-7 years, BS and >10 years
• Hands-on experience with microbial fermentation, plasmid DNA production, and/or enzymatic processes (e.g., IVT)
• Experience supporting GMP manufacturing and tech transfer to pilot or commercial facilities.
• Strong understanding of bioreactor operations, process scale-up principles, and GMP requirements, including ability to troubleshoot complex biological and biochemical processes
• Proven ability to lead complex technical programs and influence cross-functional stakeholders
• Strong technical execution and problem-solving skills
• GMP mindset and documentation rigor
• Adaptability in a fast-paced development environment

Preferred experience

• Direct experience with mRNA-based therapeutics and IVT process scale-up
• Experience working with CDMOs and managing external manufacturing relationships
• Familiarity with process modeling, DoE, and statistical data analysis tools
• Experience supporting late-stage clinical or commercial programs

This position requires authorization to work in the United States. Tune does not currently sponsor employment visas for this role.