Job description
LuminaBio Therapeutics is a fast-growing biotech company focused on deploying novel bioprocesses to accelerate patient access to life-saving therapies. We are seeking a Senior Bioprocess Engineer to lead scalable manufacturing development and help us bring next-generation biologics from bench to bedside. This role offers a unique opportunity to influence process robustness, equipment selection, and tech transfer across CMO partnerships in a collaborative, fast-paced environment.
As a member of our Bioprocess Development team, you will design, optimize, and scale upstream/downstream processes, implement control strategies, and ensure GMP-compliant operations. You will partner with analytical, formulation, and QA teams to deliver consistent product quality and supply for clinical and commercial programs.
What we offer: competitive compensation, equity, comprehensive benefits, ongoing training, and a culture of innovation in the heart of Cambridge’s biotech ecosystem.
Responsibility
- Lead design, optimization, and scale-up of upstream and downstream bioprocesses for recombinant proteins and biologics.
- Develop and execute tech transfer plans from lab to pilot and commercial scales with cross-functional teams.
- Implement quality by design (QbD) and process validation strategies to ensure GMP-compliant operations.
- Design robust experiments, analyze data, and communicate results to stakeholders.
- Collaborate with manufacturing and facilities teams to ensure equipment readiness and process robustness.
- Support process characterization, impurity profiling, and OPS/OSP documentation.
- Mentor junior engineers and contribute to CapEx justifications for process improvements.
- Support regulatory submissions with technical dossiers and manufacturing details as needed.
Qualification
- BS/MS in Chemical Engineering, Biochemical Engineering, or related field; PhD preferred.
- 7+ years of experience in bioprocess development or manufacturing in pharma/biotech settings.
- Proven track record in scale-up/downstream/upstream processes and tech transfer.
- Strong understanding of GMP, regulatory requirements, and quality systems (QA/QC).
- Hands-on experience with bioreactor operations, purification systems, and analytics.
- Excellent problem-solving, data analysis (statistical), and project management skills.
- Effective communication and cross-functional collaboration abilities.
- Experience with design of experiments (DoE) and process validation is a plus.