Senior Director, Technical Operations

Job Description

Job Description

Salary : $225-250k

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 doesnt 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 are seeking a Senior Director of Technical Operations at SpyGlass Pharma, who will play a pivotal role in leading and managing the tech transfer of manufacturing processes for small molecule ophthalmic drug delivery systems. This position demands a deep understanding of tech transfer, manufacturing processes, regulatory compliance, quality assurance, and leadership skills to ensure the successful production and scale-up of pharmaceutical products through effective collaboration with external partners. As an integral member of the Research & Development leadership team, this individual will work closely with internal teams and external partners to ensure manufacturing and delivery of drug products for clinical studies and commercial purposes.

Essential Duties & Responsibilities :

• Lead the tech transfer of manufacturing processes to Contract Manufacturing Organizations (CMOs) to ensure the production of high-quality pharmaceutical products.
• Develop and maintain procedures (SOPs) and processes in collaboration with Quality and Development organizations to support Pharmaceutical Manufacturing, including but not limited to Equipment and Process Validation, Technology Transfer, Process Monitoring / Controls.
• Ensure adherence to Current Good Manufacturing Practices (cGMP), regulatory requirements, and safety standards in pharmaceutical manufacturing.
• Collaborate with cross-functional teams, including formulation development, process development, quality assurance, engineering and regulatory affairs, to support product manufacturing and delivery for clinical studies and commercial supply.
• Manage relationships with CMOs to ensure timely and cost-effective production.
• Develop and monitor tech transfer and manufacturing budgets, timelines, and resources to ensure the successful execution of manufacturing projects.
• Provides technical input to resolve manufacturing process challenges.
• Identify and implement process improvements to enhance efficiency, quality, and scalability of the supply chain.
• Ensure accurate and timely documentation of manufacturing processes, protocols, and reports.
• Support the preparation of regulatory submissions and audits including PAIs, providing necessary documentation and responses to regulatory agencies.

Qualifications Required For Position :

Why SpyGlass Pharma?

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.