- Manage daily activities supporting the development and characterization of small molecule ophthalmic drug delivery implants.
- Serve as subject matter expert (SME) for creating robust, phase-appropriate formulations and manufacturing processes ensuring product quality, safety, and efficacy.
- Lead a team of scientists and engineers in designing, executing, and interpreting development studies for preclinical and clinical stage programs.
- Collaborate with cross-functional team members including formulation development, process development, engineering, analytical chemistry, regulatory affairs, quality assurance, and manufacturing.
- Author, review, and approve scientific protocols and reports.
- Direct activities with Contract Development and Manufacturing Organizations (CDMO) and Contract Research Organizations (CRO) to ensure high-quality and timely outcomes.
- Establish and provide scientific justification for drug substance, drug product, and raw material specifications.
- Contribute to the preparation of regulatory documents, including INDs, NDAs, and marketing authorization applications, ensuring compliance with regulatory requirements.
- Manage project timelines, budgets, and resources to ensure timely and cost-effective delivery of development milestones.
- Foster a culture of collaboration, creativity, and excellence within the pharmaceutical development team.
- PhD or equivalent degree in pharmaceutical sciences, chemistry, biochemistry, or related field with a minimum of 8 years of experience in small molecule pharmaceutical development within a pharmaceutical company or CDMO.
- Bachelor's or equivalent degree in pharmaceutical sciences, chemistry, biochemistry, or related field with a minimum of 12 years of experience in small molecule pharmaceutical development within a pharmaceutical company or CDMO.
- Demonstrated ability to successfully support lates stage development and registration activities.
- Expertise in quality by design, quality risk management, and statistical methods related to sustained release dosage form development.
- 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 scientific concepts to diverse stakeholders.
- Experience with phase-appropriate regulatory requirements, submissions, and interactions with regulatory agencies (FDA, EMA, etc.).
- Proficiency in project management tools and software (e.g., MS Project, Smartsheet) is preferred.
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Associate Director, Pharmaceutical Development - Aliso Viejo, United States - Spyglass Pharma
Description
Job Description
Job DescriptionSalary: $150k - $175kAbout 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 PharmaTM 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
Summary:
The Associate Director of Pharmaceutical Development will play a key role in leading and managing the development and characterization of small molecule ophthalmic drug delivery implants. This position requires expertise in formulation development, manufacturing processes, regulatory compliance, and team leadership to ensure the successful progression of pharmaceutical development programs.
Essential Duties & Responsibilities:
Qualifications Required For Position:
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 .COM and let us know the nature of your request and your contact information.
Associate Director, Pharmaceutical Development professionals in Aliso Viejo
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Jim Mirza
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