Analytical Development - Manager / Sr. Manager

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 cha

Additional Information

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

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