About SpyGlass Pharma:

At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.

We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra, “We create for patients” doesn’t just live on our walls but drives our decision making as we build the company, creating the products, processes and culture that make it happen.

This team has delivered a solid foundation of development and clinical data, enabling over $200 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.

Summary:

We’re seeking a Senior Manufacturing Process Engineer, Technical Operations to join our team at SpyGlass Pharma. This role supports manufacturing scale-up, process improvements, technology transfer, and coordination with external manufacturing partners for pharmaceutical and drug-device combination products. Working closely with R&D Engineering, Quality, Regulatory, and Supply Chain, this position helps ensure manufacturing processes are reliable, scalable, and compliant while supporting key clinical and commercial milestones. The ideal candidate is a hands-on problem solver who takes ownership of projects and thrives in a fast-paced pharmaceutical or medical device development environment.

Essential Duties & Responsibilities:

Manufacturing Engineering

• Serve as a key technical contributor in efforts to scale, stabilize, and optimize manufacturing processes in ISO 5/7/8 environments.
• Collaborate on process validation strategy and execution with Quality and CMOs.
• Ensure manufacturing processes are efficient, compliant, and inspection-ready.
• Maintain disciplined documentation practices to support regulatory submissions, audits, and lifecycle management.
• Provide structured project updates, risk assessments, and mitigation plans to leadership.

CMO & Technical Transfer Oversight

• Serve as technical liaison between SpyGlass and CMOs.
• Serve as a key technical contributor in leading technology transfers from R&D to commercial manufacturing in partnership with department heads, ensuring smooth execution.
• Support validation strategies, change controls, and technical documentation alignment.
• Monitor performance and identify potential quality, cost, or supply risks.
• Foster accountability and collaboration with external manufacturing partners.

Automation & Inspection Systems

• Participate in the development and implementation of scalable inspection platforms and custom fixtures.
• Support improvements in inspection robustness, throughput, and repeatability.
• Ensure inspection systems meet regulatory and operational requirements.

Compliance & Continuous Improvement

• Ensure alignment with cGMP and applicable regulatory requirements.
• Support audit readiness and regulatory inspections.
• Assist in root cause investigations and corrective actions.
• Contribute to continuous improvement initiatives to enhance reliability and reduce operational complexity.

Qualifications Required For Position:

• Bachelor’s degree in Engineering or related technical field required; advanced degree preferred.
• 3-5+ years of experience in pharmaceutical, medical device, or combination product manufacturing, with exposure to scale-up, tech transfer, validation, and CMO oversight.
• Experience working with Contract Manufacturing Organizations (CMOs), including technical transfers and performance oversight.
• Understanding of cGMP, FDA regulations, and applicable quality standards.
• Experience in ISO 5/7/8 environments and controlled manufacturing processes preferred.
• Exposure to automation, inspection systems, and fixture design is preferred.
• Demonstrated ability to contribute to cross-functional initiatives and coordinate with Engineering, Quality, Regulatory, and Supply Chain.
• Structured problem-solving skills, including risk assessment and data-driven decision-making.
• Experience with ophthalmic products, drug–device combination products, or implantable systems is highly desirable.

Why SpyGlass Pharma?

• We are offering a range of $130,000 - $150,000, based on experience and qualifications, along with an Annual Bonus opportunity.
• Share in our success with stock options, giving you a stake in the company’s future.
• Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.
• Generous paid time off, including holidays, vacation days, and personal leave.

SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to JOBS@SPYGLASSPHARMA.COM and let us know the nature of your request and your contact information.