Director, Pharmaceutical Development - Aliso Viejo - Spyglass Pharma

    Spyglass Pharma
    Spyglass Pharma Aliso Viejo

    1 day ago

    Description

    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 $200 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:
    We are seeking a Director of Pharmaceutical Development to join our dynamic team. As a Director Pharmaceutical Development, you will oversee pharmaceutical development activities for implantable drug delivery products used in ophthalmology. This role requires a deep understanding of formulation science, preformulation, polymer science, process development, and regulatory CMC requirements. The Director will lead cross-functional technical teams, oversee external development partners and CMOs, and play a key role in authoring and reviewing regulatory submissions.
    Essential Duties & Responsibilities:

    • Lead and manage the formulation and process development teams for sustained release drug delivery and drug/device combination products.
    • Serve as an SME for the creation of robust, phase appropriate formulations and manufacturing processes which ensure product quality, safety, and efficacy.
    • Manage a team of scientists, engineers and technicians in the design, execution, and interpretation of technical studies to support preclinical and clinical stage programs.
    • Collaborate with cross-functional team members including manufacturing, engineering, analytical chemistry, regulatory affairs, and quality assurance.
    • Manage CDMO activities; identify and coordinate with third party suppliers.
    • Develop and establish product specifications.
    • Contribute to the preparation of CMC sections in regulatory submissions.
    Qualifications Required For Position:
    • PhD or MS in pharmaceutical sciences, chemical engineering, or a related field with a minimum of 10 years of experience in pharmaceutical development. At least 3 years of experience in a leadership role.
    • Track record of successful sustained release drug delivery product development. Experience supporting Phase 3 through product approval highly desired.
    • Understanding of drug/device combination product development needs.
    • Strong leadership and interpersonal skills with the ability to effectively lead and motivate cross-functional teams and external partners.
    • Excellent written and verbal communication skills, with the ability to communicate complex scientific concepts to diverse stakeholders.
    • Hands-on experience with tech transfer, scale-up, and GMP manufacturing.
    Why SpyGlass Pharma?
    • We are offering a range of $175,000 - $225,000, 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.
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