Analytical Development - Manager / Sr. Manager

About BridgeBio: BridgeBio is a premier, internationally recognized biopharmaceutical company, genetic science pioneer, and breakthrough medicine innovator on an absolute mission to discover, create, test, and deliver transformative targeted therapies for patients suffering from life-threatening genetic diseases and cancers with clear genetic drivers. Founded in 2015, the organization pioneered a disruptive, high-leverage “moneyball for biotech” approach, pooling promising early-stage academic research under a single financial and operational umbrella to structurally reduce clinical risk and unleash uncompromised innovation. With an active portfolio of 20 plus drug development programs ranging from preclinical stages to late-stage Phase III trials across cardiology precision oncology, neurology, and endocrinology therapeutic areas, BridgeBio values radical curiosity, rapid execution velocity, and the thoughtful use of advanced AI to maximize work quality. The company provides high-agency technical leaders with an uncompromised remote canvas to manage complex data tracks, optimize contract manufacturing ecosystems, and engineer lifesaving pharmaceutical pipelines safely worldwide.

Position Overview

We are seeking a highly analytical, systems-minded Senior Manager of Analytical Development to join our core centralized Chemistry and Manufacturing and Controls (CMC) division in a full-time remote capacity across the United States. Reporting directly to an Analytical Development Director, you will step up to claim individual strategic operational accountability for executing late-stage clinical development workflows and managing outsourced analytical activities at contract manufacturing sites and testing labs. Shifting completely away from legacy bench chemistry execution or routine laboratory record logging, you will act as a principal technical architect—managing contract development and manufacturing organizations (CDMOs) to guarantee high-fidelity data validation for both drug substances (DS) and drug products (DP). This position requires a pharmaceutical industry veteran with 7 plus years of analytical history who oversees external CMO chemists fluidly natively using Research governance metrics, authors CMC regulatory dossiers smoothly natively using Technical Writer frameworks, and trends GMP stability records confidently.

Key Responsibilities

• CDMO and Vendor Operations Governance: Oversee, audit, and manage external contract development and manufacturing organizations (CDMOs) handling analytical development and quality control (QC) actions for drug substance and drug products natively utilizing Research frameworks.
• QMS Documentation Administration: Direct, organize, and maintain critical analytical documentation rows—including Certificates of Analysis (CofAs), test method specifications, operational validation protocols, shelf-life data sheets, and raw laboratory data logs within the corporate Quality Management System (QMS).
• Regulatory Dossier Content Architecture: Author, refine, and compile technical analytical sections for CMC Regulatory dossiers, contributing structural data blocks to support upcoming U.S. IND filings and Rest of World (ROW) IMPD inquiry response loops natively leveraging Technical Writer principles.
• GMP Stability Studies and Trend Analysis: Manage Good Manufacturing Practice (GMP) stability validation programs, generating complex trend analysis charts to back stop shelf-life extensions and retest data parameters.
• Reference Standard Program Management: Govern the company’s core reference standard asset inventory, managing precise qualification metrics, strict storage environments, material distribution routes, and real-time counts.
• Method Validation and Compendial Verification: Oversee the development, optimization, and phase-appropriate validation of analytical method definitions (including HPLC, LC/MS, GC/MS, and UV/Vis spectroscopy systems) alongside the verification of compendial methods.
• Technical Audit Representation: Serve as the principal analytical subject matter representative during formal corporate quality audits, participating in site inspections and authoring data-backed audit summary reports.
• Cross-Functional Technical Alignment: Partner in lockstep with distributed process chemists, quality assurance teams, and commercial project managers to prioritize analytical data pipelines against strict clinical timelines.

Required Skills & Qualifications

• At least 7 years of verified professional history running commercial analytical development, pharmaceutical quality control engineering, CMC regulatory compilation, or pharmaceutical systems consulting.
• Proven professional history managing, directing, and evaluating outsourced analytical chemists, testing teams, or contract research organizations (CRO/CMO management matrices).
• Deep, authoritative technical command of advanced pharmaceutical analysis methodologies, including hands-on familiarity with HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, and phase-appropriate analytical method validation guidelines.
• Expert-tier capability reviewing system validation logs, parsing chemical data anomalies, and structuring quality controls natively utilizing Research tracking principles.
• Practical operational familiarity authoring regulatory filings, interpreting FDA/EMA policies, and applying ICH guidelines natively using Technical Writer documentation standards.
• Demonstrated ability to adapt to rapid changes in corporate project scopes and priorities on short notice, with the capacity to make independent technical choices under tight deadlines.
• Outstanding verbal, written, and document communication attributes in fluent English, enabling uncompromised clarity when conveying scientific data results to both internal executives and external vendors.
• Travel Notice: Operational readiness and availability to travel up to 20 percent to facilitate onsite contract manufacturing organization (CDMO) alignment, audit loops, or project launches.
• Location Context: Position open to qualified analytical development experts based permanently and resident within the United States to operate under a 100% remote home-office layout.

Preferred Strategic Indicators (Nice to Have)

• Prior commercial analytics history operating explicitly within rare disease drug frameworks, molecular oncology startups, precision cardiology projects, or large-scale commercial biopharma launch teams.
• Experience utilizing advanced statistical computing platforms to plot automated retest intervals or shelf-life decay analytics.
• An outcome-driven personal philosophy rooted in high intellectual curiosity, a passion for reengineering the future of biopharma, and an absolute lack of fear when asked to achieve the impossible for patients with unmet medical needs.

What We Offer

• Market-Competitive Salaried Blueprint: An attractive full-time base salary package anticipated between $163,800 and $177,400 USD per year (for California-based candidates, calibrated transparently based on industry experience depth), supplemented by annual performance bonuses and corporate equity opportunities.
• The exceptional professional canvas to directly direct, shape, and code-verify the analytical models and validation paths power-routing life-changing therapeutics through FDA approval pipelines.
• Profound work-from-home remote parameters offering an elite hybrid or fully distributed framework, complete scheduling trust, and zero physical office commuting friction across America.
• Immediate baseline access to premium lifestyle protections, providing 100% employer-paid medical, dental, and vision insurance premiums for you and your legal dependents from day one.
• Access to elite financial accumulation and family-forming tracks, featuring a 401(k) plan with company matching, an Employee Stock Purchase Program (ESPP), Health Savings Accounts (HSA) with annual employer injections, and comprehensive fertility/parental leaves.
• Generous personal recharging benefits, providing a flexible “take-what-you-need” paid time off layout paired with dedicated company-paid holiday blocks.
• Structured career pathing and internal mobility engines powered by regular executive feedback loops and professional development programs via LinkedIn Learning, LifeLabs, and BetterUp Coaching networks.