{"id":235703,"url":"https://alion.io/job/bridgebio-pharma-managersr-manager-analytical-development","title":"Manager/Sr. Manager, Analytical Development","company":{"id":3681,"name":"BridgeBio Pharma","domain":"bridgebiopharma.com","url":"https://alion.io/company/bridgebiopharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":90,"open_postings":14,"ghost_share":0,"stale_share":0.214,"repost_share":0,"time_to_fill_p50_days":63,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Francisco, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":189000,"max_usd":332000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":356},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"JMP","optional":false},{"name":"LIMS","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-09-01T00:59:46Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-11-01T21:46:10Z","board_verified":true,"closed_at":null,"days_open":61,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":61},"description":"Mavericks Wanted \nWhen was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on \nIn 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. \nTogether we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask \"why not?\" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. \nWhat You'll Do\nBridgeBio seeks a motivated, knowledgeable, and hands-on analytical development scientist and quality control professional to manage analytical development, QC, and stability activities at contract manufacturing sites and to contribute to the development of clinical assets and regulatory submissions. This position requires close collaboration with the Drug Substance, Drug Product, and Quality Assurance groups. This candidate should know the various analytical techniques across modalities. In addition, this individual should be experienced in test method development, analytical method transfer, phase-appropriate method validation, and stability program management (including data trending and analysis) for both drug substances and drug products. A thorough understanding of relevant ICH quality guidelines and excellent communication skills (both verbal and written) is required. \nResponsibilities\n· Management of contract drug substance and drug productanalytical development and quality control activities and timelines\n· Authoring and review of analytical method transfer and validation protocols and reports\n· Direct batch release support by reviewing and approving sampling plans and analytical data; generate and maintain CoAs, CoTs, and product specifications\n· Review stability protocols and monitor various stability programs\n· Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings\n· Partner with QA to manage change controls; lead OOS/OOT and deviation investigations to identify root causes and implement CAPAs\n· Develop, revise, and approve SOPs and QC processes, enhancing compliance, consistency, and operational efficiency\nWhere You'll Work\nThis is a hybrid role and requires in-office collaboration 2x per week in our San Francisco office.\nWho You Are\nAt least 10 years of experience in Analytical Development and/or Quality Control in a pharmaceutical setting.\nFamiliarity with CMC analytical regulatory requirements and authoring of IND/IMPD/BLA/NDA/MAA filings and responses to regulatory inquiries\nIndependently proficient in a variety of analytical techniques in support of biologic and small molecule development. \nAbility to communicate effectively with vendors regarding project scope, scientific results and project updates. Ability to understand project timelines and appropriately prioritize activities to achieve project goals.\nThorough understanding of cGMPs, USP and ICH guidelines, and industry best practices.\nSubject matter expertise in stability program management, including protocol design, data trending and analysis (e.g., using JMP), and shelf-life assignment/extension.\nProficient with enterprise quality management systems such as Veeva Vault, TrackWise, and LIMS.\nThe position will require an ability to adapt to changes in priorities on short notice and will also require an ability to make decisions, independently, under tight timelines.\nPosition requires 5-15% travel. Must have the ability to travel internationally.\nAt BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.\nSalary\n$153,000—$185,000 USD\nAs a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.\nFor BridgeBio Full-Time U.S Based Roles:\nFinancial & Rewards \nMarket-leading compensation \n 401(k) with employer match \n Employee Stock Purchase Program (ESPP) \n Pre-tax commuter benefits (transit and parking) \nReferral bonus for hired candidates \nSubsidized lunch and parking on in-office days \nHealth & Well-Being \n100% employer-paid medical, dental, and vision premiums for you and your dependents \n Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA) \nFertility & family-forming benefits \n Expanded mental health support (therapy and coaching resources) \nHybrid work model with flexibility \nFlexible, “take-what-you-need” paid time off and company-paid holidays \nComprehensive paid medical and parental leave to care for yourself and your family \nSkill Development & Career Paths: \nPeople 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 \nWe provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching \nWe celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities \nBy applying, you acknowledge that BridgeBio will process your personal information as described in our Global Candidate Privacy Notice. 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