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Director, Analytical Development-Technical Operations - Job Opportunity at Star Therapeutics

South San Francisco, USA
Full-time
Senior
Posted: January 19, 2025
On-site
USD 184,000 - 230,000 per year

Benefits

Competitive stock options package indicating high-growth potential
Comprehensive healthcare benefits (implied based on company type)
Professional development opportunities through industry exposure

Key Responsibilities

Strategic leadership of analytical method development across product lifecycle Responsible for end-to-end analytical strategy from early clinical trials through commercialization
Cross-functional collaboration with Quality Assurance, Regulatory Affairs, and CMC teams Direct oversight of external partnerships and CDMO relationships
Implementation of stability programs and analytical method validation strategies Critical decision-making for product development pathways

Requirements

Education

PhD or MS in chemistry, biology, bio/chemical engineering, or related discipline

Experience

PhD with 10+ years or Master's degree with 12+ years in biotechnology/pharmaceuticals

Required Skills

Method development and validation expertise Physical chemistry and biochemistry knowledge Statistical analysis and DoE proficiency cGMP regulatory knowledge Project management capabilities Technical documentation expertise Strategic planning ability Communication skills
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on biosimilar development driving demand for analytical expertise Regulatory requirements becoming more stringent, especially for monoclonal antibodies Growing emphasis on Quality by Design principles in pharmaceutical development Rising importance of robust analytical methods in biological drug development

Salary Evaluation

The offered salary range is competitive for the Bay Area biotech sector, falling within the 75th percentile for similar director-level positions The range allows for experience-based differentiation while remaining attractive for senior talent

Role Significance

Typically leads a team of 5-8 analytical scientists while managing multiple CDMO relationships
Senior leadership position with direct impact on product development strategy and regulatory success

Key Projects

Method development and validation for novel biological products Technology transfer to manufacturing sites Regulatory filing preparation and strategy development

Success Factors

Strong technical expertise combined with strategic vision for analytical development Ability to navigate complex regulatory requirements while maintaining development timelines Excellent stakeholder management skills across internal teams and external partners

Market Demand

Very high demand due to expanding biologics pipeline across industry and limited pool of experienced analytical development leaders

Important Skills

Critical Skills

Analytical method development expertise is crucial for establishing robust product characterization Regulatory knowledge essential for successful IND/BLA submissions Strategic planning capability critical for program success

Beneficial Skills

Experience with multiple analytical platforms enhances versatility Understanding of commercial manufacturing requirements aids long-term planning International regulatory knowledge provides broader development perspective

Unique Aspects

Significant emphasis on external partner management indicating strategic outsourcing model
Focus on monoclonal antibody development suggesting specialized therapeutic focus
Strong emphasis on method development indicating early-stage pipeline

Career Growth

Typical progression to VP level within 3-5 years based on company growth and success

Potential Next Roles

VP of Technical Operations VP of CMC Chief Technology Officer

Company Overview

Star Therapeutics

Star Therapeutics appears to be a growth-stage biotech company focused on innovative therapeutic development

Emerging player in the competitive Bay Area biotech landscape with focus on novel therapeutic approaches
Strategically located in South San Francisco biotech hub with access to key talent and resources
Fast-paced, innovation-focused environment typical of growing biotech companies with emphasis on scientific excellence
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