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Manager, Quality Control - Job Opportunity at BridgeBio (Calcilytix)

Remote, United States
Full-time
Senior
Posted: January 29, 2025
Remote
USD 130,000-155,000 per year

Benefits

Comprehensive health insurance with competitive coverage
Life insurance with family protection
Flexible PTO policy supporting work-life balance
Vision insurance with modern coverage options
Performance bonus structure
Equity compensation
Professional development resources
Retirement programs

Key Responsibilities

Lead analytical data review for drug release, stability, and in-process testing at CMOs
Oversee quality control laboratories including investigation of out-of-specification results
Manage method validation and transfer activities for pharmaceutical testing
Direct communication with internal teams and external partners
Develop and review Standard Operating Procedures
Ensure cGMP compliance across analytical operations
Coordinate with Contract Manufacturing Organizations for quality control

Requirements

Education

M.S./B.S. in life sciences, ideally Chemistry, Analytical Chemistry preferred

Experience

5+ years in Quality Control in pharmaceutical setting, 2+ years management experience

Required Skills

GMP expertise Analytical technique knowledge (HPLC, GC, GC/MS, LC/MS, ICP) Leadership abilities Strong communication skills Project management Regulatory compliance Data analysis Laboratory operations Quality control systems
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on rare disease therapeutics and orphan drug development is creating specialized QC roles Growing demand for remote quality control positions as pharma companies adopt decentralized operations Rising importance of data integrity and electronic systems in quality control operations Shift towards integrated quality management systems across global supply chains

Salary Evaluation

The offered range of USD 130,000-155,000 is competitive for senior QC positions, reflecting the specialized nature of rare disease development and the company's growth stage. Market rates for similar roles typically range from USD 125,000-170,000 depending on location and experience.

Role Significance

Typically manages 3-7 direct reports in quality control operations, coordinating with multiple CMO teams
Senior management position with significant influence on product quality and regulatory compliance

Key Projects

Method validation and transfer programs CMO quality oversight initiatives Regulatory submission support Quality system enhancement projects Stability program management

Success Factors

Deep understanding of analytical chemistry and quality control principles Strong vendor management capabilities Ability to navigate complex regulatory requirements Excellence in technical documentation and review Strategic thinking in quality control process optimization

Market Demand

High demand position due to expansion in rare disease therapeutics and increasing regulatory requirements for quality control in pharmaceutical manufacturing

Important Skills

Critical Skills

Quality control expertise in pharmaceutical setting CMO management experience Technical proficiency in analytical methods Regulatory knowledge Project management capabilities

Beneficial Skills

Experience with rare disease development Knowledge of quality systems Understanding of drug development process Strategic planning abilities Change management skills

Unique Aspects

Opportunity to work with multiple therapeutic programs across subsidiaries
Focus on rare disease therapeutics with high unmet need
Decentralized operational model allowing for significant autonomy
Direct impact on development of breakthrough therapies

Career Growth

Typically 2-4 years in role before advancement, depending on company growth and performance

Potential Next Roles

Director of Quality Control Senior Director of Quality Head of CMC Quality Site Head

Company Overview

BridgeBio (Calcilytix)

BridgeBio is a rapidly growing biopharmaceutical company focused on genetic diseases and targeted oncology, with a unique distributed business model

Mid-sized but expanding biopharmaceutical company with strong venture backing and multiple late-stage programs
Strong US presence with growing international operations, particularly in Canada and Switzerland
Innovation-driven environment with emphasis on rapid development and patient focus
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