- Lead analytical development and operations from early to late development through commercialization.
- Be accountable for analytical-related development strategies, overseeing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization.
- Author, review, and approve relevant CMC sections for global regulatory filings.
- Lead cross-functional CMC team for the project(s) assigned to ensure adequate development and execution of CMC plan and strategies as needed.
- 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 (drug substance, drug product, supply chain, quality, CMC regulatory, CMC PM, Clinical, DMPK, tox, and program management) to meet CMC and program goals.
- Lead the efforts to assess and identify potential suppliers for analytical development and QC activities supporting drug substance and drug product development and manufacturing with adequate risk assessment.
- Travel to CDMOs and CTLs for vendor assessment and qualification, as well as analytical activities oversight as needed
- Minimum MSc degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or a closely related field
- A PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or a closely related field is preferred.
- 18+ years of experience in the pharmaceutical/biotech industry with a sound track record of technical expertise and organizational leadership, early and late phase analytical development, and operations experience of small molecules with commercial experience a plus
- Extensive experience in late-phase innovative drug development and commercial launch with global CMC regulatory filings (IND/NDA/MAA, etc.)
- Proven track record of strategic leadership and management with at least 10 years in a management role
- Demonstrated project and cross-functional team leadership, as well as people management skills
- Thorough understanding and working experience in innovative drug development and manufacturing concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
- Extensive working experience with management and oversight of the analytical activities at CDMOs or CTLs
- Strong problem-solving skills with strategic and sound technically driven decision-making ability
- Effective written and verbal communication skills and interpersonal skills
- Innovative team player with high energy for our dynamic company environment
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VP, Analytical Development and Quality - Santa Clara, United States - Bayside Solutions
Description
VP, Analytical Development and Quality
Direct Hire Full-Time Role
Salary Range: $279,200 - $300,000 per year
Location: Redwood City, CA - Onsite Role
Job Summary:
As a senior leadership role within the Pharmaceutical Development and Manufacturing (PDM) organization, you will be accountable for analytical development and operations supporting clinical development and commercialization of the compounds. You will provide technical, organizational, and strategic leadership, working closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the integrated development plan and program timelines. You will be critical in the overall CMC strategy planning and execution.
Duties and Responsibilities:
Requirements and Qualifications:
Desired Skills and Experience
Pharmaceutical development, analytical development, quality control, CMC regulatory, GMP, ICH guidelines, FDA, analytical chemistry, organic chemistry, physical chemistry
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