Senior Process Engineer, Pharmaceutical Manufacturing
4 weeks ago
About SpyGlass Pharma:
At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care.
Our team comprises professionals with diverse expertise in ophthalmic devices and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology, IOL development, and commercial success. Led by a proven team with expertise in science, R&D, communications, and operations, SpyGlass Pharma™ takes ideas from inception through commercialization.
Our commitment to actively improving patients’ quality of life drives the company to innovate and succeed.
Learn more at www.spyglasspharma.com
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 AND 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.
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.
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