Director, Pharmaceutical Development

Spyglass Pharma • Aliso Viejo, CA

1d • $175,000 - $225,000 • Onsite

About The Position

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.

Requirements

• 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree