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Lead Process Engineer in Pharmaceutical Production
2 months ago
Salary Range: $120k - $140k
About SpyGlass Pharma:
SpyGlass Pharma is dedicated to addressing critical needs in the fields of glaucoma and cataract surgery, focusing on innovative solutions in global eye care.
Our team consists of experts in ophthalmic devices and drug delivery systems, working under a leadership group with extensive experience in ophthalmology, IOL development, and successful commercialization. We are committed to transforming ideas into market-ready products.
Our mission is to enhance the quality of life for patients through continuous innovation and excellence.
POSITION SUMMARY:
The Senior Process Engineer in Pharmaceutical Manufacturing will play a pivotal role in the development, enhancement, and scaling of manufacturing processes for pharmaceutical products. This position requires collaboration with various teams to ensure processes are efficient, compliant, and scalable. The ideal candidate will possess significant experience in process engineering within the pharmaceutical sector, particularly in ophthalmic products or similar areas.
KEY RESPONSIBILITIES:
- Design and refine manufacturing and tech transfer processes for pharmaceutical products, emphasizing efficiency, scalability, and quality.
- Manage the transition of processes from R&D to manufacturing, ensuring seamless integration and adherence to project schedules.
- Facilitate the tech transfer of manufacturing processes to Contract Manufacturing Organizations (CMOs) to guarantee the production of high-quality pharmaceutical products.
- Lead process validation initiatives, including the creation of validation protocols, execution of validation studies, and preparation of validation documentation.
- Ensure compliance with regulatory standards and cGMP guidelines, including thorough documentation and adherence to quality management systems.
- Identify and address process-related challenges, implementing corrective measures and enhancements to boost productivity and product quality.
- Collaborate with R&D, Quality Assurance, Manufacturing, and Regulatory Affairs teams to support product development and market introduction.
- Maintain comprehensive and precise documentation of processes, modifications, and validations to support regulatory submissions and internal audits.
QUALIFICATIONS:
- Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, or a related discipline; advanced degrees (e.g., Master's, PhD) are preferred.
- A minimum of 8 years of experience in pharmaceutical manufacturing process engineering, focusing on tech transfer, process optimization, and validation.
- Familiarity with Aseptic Manufacturing techniques to manage particulate matter and bioburden is advantageous.
- Extensive knowledge of process engineering principles, cGMP regulations, and regulatory requirements for pharmaceutical manufacturing.
- Strong analytical and problem-solving skills, with the capability to assess complex issues and implement effective solutions. Proficiency in process modeling and simulation software (e.g., Aspen Plus, MATLAB) is a plus.
- Demonstrated ability to lead cross-functional teams and manage intricate projects. Excellent communication and interpersonal skills are essential.
- Experience with ophthalmic drug delivery systems or related pharmaceutical products is highly desirable.
SpyGlass Pharma is an Equal Opportunity Employer committed to diversity and inclusion in the workplace.
