- Lead drug product development activities to advance new chemical entities (NCE) from the preclinical lead optimization stage through commercialization
- Lead pre-formulation, final form selection, formulation and process development, clinical manufacturing, scale-up, tech transfer, process optimization, and process validation activities related to solid oral dosage and parenteral drug products.
- Responsible for developing strategies and overseeing the execution of technical activities associated with product development and manufacturing, supporting clinical development, regulatory filings (IND/NDA/MAA), and product approvals and commercialization.
- Design and oversee execution of QbD and risk-based studies, as well as process development activities in preparation for registration, validation, and commercialization activities.
- Author and review technical reports and CMC-related documents required for regulatory submissions.
- Build and maintain a high-performing team to support the ongoing pipeline.
- Strategic and technical oversight of internal staff and Contract Manufacturing Organizations (CMOs)
- Lead cross-functional CMC team for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies.
- Serve as a project core team member, communicate CMC strategy and project status to key stakeholders cross-functionally, and assist in driving decision-making.
- Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to meet CMC and program goals.
- Travel to CDMOs for vendor assessment and qualification and manufacturing oversight as needed.
- A PhD (minimum MSc) in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field is desirable.
- 18+ years of experience in the pharmaceutical/biotech industry with a sound track record of technical expertise, leadership, and early and late-phase drug product development experience with small molecules
- Demonstrated strong project and cross-functional team leadership and people management skills
- Leadership experience in late-stage product development, scale-up, tech transfer, and process optimization of solid oral dosage and parenteral formulations is a plus.
- Thorough understanding and working experience of pharmaceutical drug products concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
- Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China
- Exceptional problem-solving skills with strategic and sound technically driven decision-making ability
- Excellent written and verbal communication skills and interpersonal skills
- Innovative team player with high energy for our dynamic company environment
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Senior Director, Drug Product - Fremont, United States - Bayside Solutions
Description
Senior Director, Drug Product
Direct Hire Full-Time Role
Salary Range: $224,600 - $245,000 per year
Location: Redwood City, CA - Hybrid Role
Job Summary:
Playing a critical role as the drug product technical lead and CMC project lead, this position will be responsible for drug product development activities leading to NDA submission and commercialization and development and execution of the CMC strategy. You will provide technical and project leadership and work with cross-functional stakeholders to ensure pharmaceutical drug product development and CMC activities are executed seamlessly and in alignment with the integrated product development plan and program timelines.
Duties and Responsibilities:
Requirements and Qualifications:
Desired Skills and Experience
Pharmaceutical Development, late-phase drug development, CMC, small molecule, GMP, ICH, FDA, EMA, New Drug Application
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