Senior Director, Pharmaceutical Manufacturing
1 month 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 Director of Pharmaceutical Manufacturing at SpyGlass Pharma will play a pivotal role in overseeing and managing the tech transfer of manufacturing processes for small molecule ophthalmic drug delivery pads. 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.
Essential Duties & Responsibilities:
- Oversee 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 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.
- 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.
- Ensure accurate and timely documentation of manufacturing processes, protocols, and reports.
- Support the preparation of regulatory submissions and audits, providing necessary documentation and responses to regulatory agencies.
Qualifications Required For Position:
- Bachelor’s or equivalent degree in pharmaceutical sciences, chemical engineering, or a related field with a minimum of 15 years of experience in GMP pharmaceutical manufacturing/operations and tech transfer within a pharmaceutical company.
- Minimum of 5 years of senior leadership experience.
- Deep understanding of pharmaceutical processes, equipment, automation, and validation.
- Understanding of Aseptic Manufacturing techniques to control particulate matter and bioburden is preferred.
- Demonstrated ability to successfully manage tech transfer and manufacturing operations for pharmaceutical products, including late-stage development and commercial production.
- Expertise in cGMP, quality assurance, and regulatory compliance for pharmaceutical manufacturing.
- Strong leadership and interpersonal skills with the ability to effectively lead and motivate cross-functional teams.
- Excellent written and verbal communication skills, with the ability to communicate complex technical concepts to diverse stakeholders.
- Experience with regulatory submissions, inspections, and interactions with regulatory agencies (FDA, EMA, etc.).
- Proficiency in manufacturing and project management software (e.g., ERP systems, MS Project) is preferred.
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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