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Associate Director/Director, Analytical Development jobs in United States
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BridgeBio · 1 day ago

Associate Director/Director, Analytical Development

BridgeBio is a pioneering biotech company focused on developing life-changing medicines for patients with unmet needs. They are seeking an experienced Analytical Associate Director/Director to manage an analytical team overseeing contract development and quality control activities for drug substance and product suppliers. This role requires a strong understanding of GMP requirements and the ability to effectively communicate analytical development topics.
BiotechnologyHealthcarePharmaceuticalLife ScienceHealth CareMedical
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Oversee both international and US based contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for our drug substance (DS) and drug product (DP) suppliers
Lead, coach and develop a team of direct reports, fostering a high-performance growth-oriented culture
Manage DS and DP stability programs and corresponding shelf-life determinations
Regularly and clearly communicate Analytical Development and QC topics both verbally and in visual presentation form, efficiently and contextually
Support and author analytical content for CMC Regulatory for US and Rest of World dossiers
Support Quality Assurance audits, as a QC subject matter expert, as needed
Provide on-site technical support on an as-needed basis to oversee various manufacturing/scale-up/validation activities
Proactively interface effectively with other CMC team members (e.g. Process Chemistry, Formulation Development, Quality Assurance, Supply Chain, etc.)

Qualification

Analytical chemistryGMP experienceStability managementICH guidanceHPLC techniquesTeam leadershipCommunication skillsProblem-solvingAttention to detailAdaptability

Required

Degree (BS or MS) with 7+ years of relevant analytical chemistry experience
Oversite of external QC laboratories (e.g., method development, method validation & troubleshooting analytical procedures)
Experience with stability and shelf-life management
Practical working knowledge of ICH guidance
Knowledge of small molecule chemical characterization techniques
Broad understanding of analytical techniques, with a focus on (U)HPLC
Hands-on GMP experience with all phases of drug development including experiencing authoring IND/IMPD and marketing applications, as well as in-depth knowledge and complete understanding of GMP requirements
Ability to critically evaluate and troubleshoot complex problems while offering timely and informed options for resolution
Strong verbal & written communication skills, with the ability to effectively interact with and influence different functional groups across all levels of management
Position requires up to 20% travel
Strong focus on quality and attention to detail
You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies

Preferred

PhD preferred

Benefits

401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
Market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits

Company

BridgeBio

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BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.

H1B Sponsorship

BridgeBio has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (4)
2022 (4)
2021 (1)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$4.9B
Key Investors
Blue OwlQatar Investment AuthorityKohlberg Kravis Roberts & Co.,Viking Global Investors
2026-01-16Post Ipo Debt· $550M
2025-02-25Post Ipo Debt· $500M
2024-03-04Post Ipo Equity· $250M

Leadership Team

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Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
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Neil Kumar
CEO and Founder
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Company data provided by crunchbase