Senior Process Engineer, Pharmaceutical Manufacturing Job at Spyglass Pharma in

Salary: $120k - $140k

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 $120 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:

The Senior Process Engineer, Pharmaceutical Manufacturing will be responsible for the development, optimization, and scaling of manufacturing and tech transfer processes for pharmaceutical products. This role involves working closely with cross-functional teams to ensure that processes are efficient, compliant, and scalable. The ideal candidate will bring extensive experience in process engineering within the pharmaceutical industry, with a strong focus on ophthalmic products or related fields.

Essential Duties & Responsibilities:

• Develop and optimize manufacturing and tech transfer processes for pharmaceutical products, focusing on efficiency, scalability, and quality.
• Oversee the transfer of processes from R&D to manufacturing, ensuring smooth transitions and adherence to project timelines.
• Support the tech transfer of manufacturing processes to Contract Manufacturing Organizations (CMOs) to ensure the production of high-quality pharmaceutical products
• Lead process validation activities, including the development of validation protocols, execution of validation studies, and preparation of validation reports.
• Ensure processes are compliant with regulatory requirements and cGMP standards, including documentation and adherence to quality systems.
• Identify and resolve process issues, implementing corrective actions and process improvements to enhance productivity and product quality.
• Collaborate with R&D, Quality Assurance, Manufacturing, and Regulatory Affairs teams to support product development and commercialization.
• Maintain accurate and detailed documentation of processes, changes, and validations to support regulatory submissions and internal audits.

 

Qualifications Required For Position:

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, or a related field; advanced degree (e.g., Master’s, PhD) preferred.
• Minimum of 8 years of experience in pharmaceutical manufacturing process engineering, with a focus on tech transfer, process optimization, and validation.
• Understanding of Aseptic Manufacturing techniques to control particulate matter and bioburden is preferred.
• In-depth knowledge of process engineering principles, cGMP regulations, and regulatory requirements for pharmaceutical manufacturing.
• Strong problem-solving skills, with the ability to analyze complex issues and implement effective solutions. Proficiency in process modeling and simulation software (e.g., Aspen Plus, MATLAB) is desirable.
• Proven track record of leading cross-functional teams and managing complex projects. Excellent communication and interpersonal skills are essential.
• Experience with ophthalmic drug delivery systems or related pharmaceutical products is highly desirable.

Why SpyGlass Pharma?

• We are offering a range of $120,000 - $140,000, 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.