Analytical Development - Manager / Sr. Manager

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. About BridgeBio BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology and renal disease, with two approved drugs. Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada and Zurich, Switzerland, and are expanding across Europe. To learn more about our story and company culture, visit us at https://bridgebio.com Who You Are The Senior Manager of Analytical Development will join the Analytical Development Team within Chemistry and Manufacturing and Controls (CMC) and report to a Director of Analytical Development. This role will work closely with the entire CMC team to execute late-stage development activities in support of Phase III clinical trials through commercial activities. Candidates for this position will be required to work independently and have experience managing outsourced analytical activities at contract manufacturing sites and testing labs Responsibilities Oversee contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for drug substance (DS) and product (DP) Manage analytical documentation (i.e., CofAs, test methods, protocols, reports, specifications, stability, and raw data) within Quality Management System (QMS) Support and author analytical content for CMC Regulatory content for U.S. and Rest of World dossiers Manage GMP stability studies and provide trend analysis in support of retest and shelf-life extension Manage reference standard program (i.e., qualification, storage, inventory, distribution) Development and approval of specifications for raw materials, intermediates, and finished product and knowledge of regulatory requirements in the setting of specifications Development and validation of analytical methods and verification of compendial methods Able to communicate results both internally and externally through oral and written updates and formal reports as necessary Provide analytical support for API and Drug Product process development Authoring of development reports, protocols, and methods Support quality audits as a technical representative and contribute to authoring of audit reports Education, Experience & Skills Requirements At least 7 years of experience in analytical development in a pharmaceutical setting Proven leadership experience in managing analytical chemists at various levels externally (CMO mgmt.) Independently proficient in a variety of analytical techniques and regulatory areas including, but not limited to HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase appropriate analytical method validation Knowledge and direct experience with CMC analytical regulatory requirements and authoring of IND/IMPD filings and response to regulatory inquiries; experience applying regulatory guidelines (ICH, FDA, EMA, etc.) to pharmaceutical development and CMC strategy 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 The position will require an ability to adapt to changes in priorities on short notice and will also need an ability to make decisions, independently, under tight timelines Travel up to 20% 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 $163,800 — $177,400 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 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