Manager/Sr. Manager, Analytical Development

Job description

**Mavericks Wanted** When 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   In 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.    Together 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. ### What You'll Do BridgeBio 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. ### Responsibilities · Management of contract drug substance and drug product analytical development and quality control activities and timelines · Authoring and review of analytical method transfer and validation protocols and reports · Direct batch release support by reviewing and approving sampling plans and analytical data; generate and maintain CoAs, CoTs, and product specifications · Review stability protocols and monitor various stability programs · Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings · Partner with QA to manage change controls; lead OOS/OOT and deviation investigations to identify root causes and implement CAPAs · Develop, revise, and approve SOPs and QC processes, enhancing compliance, consistency, and operational efficiency ### Where You'll Work This is a hybrid role and requires in-office collaboration 2x per week in our San Francisco office. ### Who You Are At least 10 years of experience in Analytical Development and/or Quality Control in a pharmaceutical setting. - Familiarity with CMC analytical regulatory requirements and authoring of IND/IMPD/BLA/NDA/MAA filings and responses to regulatory inquiries - Independently proficient in a variety of analytical techniques in support of biologic and small molecule development. - Ability 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. - Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices. - Subject matter expertise in stability program management, including protocol design, data trending and analysis (e.g., using JMP), and shelf-life assignment/extension. - Proficient with enterprise quality management systems such as Veeva Vault, TrackWise, and LIMS. - The 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. - Position requires 5-15% travel. Must have the ability to travel internationally. At 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. Salary $153,000—$185,000 USD **As 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.** **For BridgeBio Full-Time U.S Based Roles:** **Financial & Rewards** - **Market-leading compensation** - **401(k) with employer match** - **Employee Stock Purchase Program (ESPP)** - **Pre-tax commuter benefits** (transit and parking) - **Referral bonus** for hired candidates - **Subsidized lunch and parking** on in-office days **Health & Well-Being** - **100% employer-paid medical, dental, and vision premiums** for you **and** your dependents - **Health Savings Account (HSA)** with annual employer contributions, plus **Flexible Spending Accounts (FSA)** - **Fertility & family-forming benefits** - **Expanded mental health support** (therapy and coaching resources) - **Hybrid work model** with flexibility - **Flexible, “take-what-you-need” paid time off** and company-paid holidays - **Comprehensive paid medical and parental leave** to care for yourself and your family **Skill Development & Career Paths:** - 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, & BetterUp Coaching - We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities