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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 pioneering solutions for unmet needs in ocular surgery, particularly in glaucoma and cataract procedures, aiming to transform global eye care.
Our workforce consists of specialists with varied backgrounds in ophthalmic technologies and pharmaceutical delivery systems. Our skilled scientists and engineers collaborate with a leadership team that possesses vast experience in ophthalmology, intraocular lens (IOL) development, and successful commercialization. Guided by a proficient team with expertise in scientific research, development, communication, and operational excellence, SpyGlass PharmaTM advances concepts from initial development to market launch.
We are committed to enhancing the quality of life for patients through innovation and success.
ROLE SUMMARY:
The Senior Process Engineer in Pharmaceutical Manufacturing will play a crucial role in the design, enhancement, and scaling of production and technology transfer processes for pharmaceutical products. This position requires close collaboration with multidisciplinary teams to ensure that processes are efficient, compliant, and scalable. The ideal candidate will possess extensive experience in process engineering within the pharmaceutical sector, particularly with a focus on ophthalmic products or similar areas.
KEY RESPONSIBILITIES:
- Design and refine manufacturing and technology transfer processes for pharmaceutical products, emphasizing efficiency, scalability, and quality assurance.
- Manage the transition of processes from research and development to production, ensuring seamless integration and adherence to project schedules.
- Facilitate the technology transfer of manufacturing processes to Contract Manufacturing Organizations (CMOs) to guarantee the production of high-quality pharmaceutical products.
- Lead process validation initiatives, including the formulation of validation protocols, execution of validation studies, and preparation of validation documentation.
- Ensure that processes comply with regulatory standards and current Good Manufacturing Practices (cGMP), 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 entry.
- 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, with a focus on technology transfer, process optimization, and validation.
- Familiarity with Aseptic Manufacturing techniques to manage particulate matter and bioburden is preferred.
- Comprehensive understanding of process engineering principles, cGMP regulations, and regulatory requirements in pharmaceutical manufacturing.
- Strong analytical and problem-solving abilities, with the capacity to assess complex issues and implement effective solutions. Proficiency in process modeling and simulation software (e.g., Aspen Plus, MATLAB) is advantageous.
- Demonstrated success in leading cross-functional teams and managing 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 and participates in E-Verify. We are committed to maintaining a diverse environment and do not 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 dedicated to working with and providing reasonable accommodations to individuals with disabilities.
