Associate Director/Director, Analytical Development

📋 Description

• • Join BridgeBio Pharma, a pioneering biopharmaceutical company dedicated to developing life-changing medicines for patients with unmet needs, and contribute to our mission of "moneyball for biotech."
• • We are seeking a highly skilled and experienced Associate Director/Director of Analytical Development to join our dynamic CMC team, working remotely within the USA.
• • This pivotal role involves managing an analytical team and overseeing analytical development and quality control (QC) activities conducted by multiple Contract Development and Manufacturing Organizations (CDMOs) for both drug substance (DS) and drug product (DP).
• • You will be instrumental in ensuring that all analytical activities adhere to stringent Good Manufacturing Practice (GMP) requirements across various phases of drug development.
• • Lead, mentor, and develop a team of direct reports, cultivating a high-performance, growth-oriented culture that encourages innovation and collaboration.
• • Take ownership of the DS and DP stability programs, including the management of stability studies and the determination of appropriate shelf-life for our pharmaceutical products.
• • Serve as a key communicator, regularly and clearly articulating complex Analytical Development and QC topics both verbally and through visual presentations to various stakeholders.
• • Play a crucial role in supporting and authoring the analytical sections of CMC Regulatory submissions for dossiers in the US and other global markets.
• • Provide expert support during Quality Assurance audits, acting as a subject matter expert for QC-related matters.
• • Offer on-site technical support as needed to oversee critical manufacturing, scale-up, and validation activities at CDMO sites.
• • Foster proactive and effective cross-functional collaboration with other CMC team members, including Process Chemistry, Formulation Development, Quality Assurance, Supply Chain, and other relevant departments.
• • Embrace BridgeBio's innovative spirit by exploring and implementing the ethical and thoughtful use of AI to enhance clarity, speed, and quality in your work.
• • This role is US-based and remote, with the expectation of quarterly or as-needed visits to our San Francisco office.
• • You will be a key contributor to BridgeBio's unique approach of pooling promising early-stage research to reduce risk and accelerate the development of groundbreaking therapies.
• • Drive scientific excellence by ensuring the robustness and reliability of analytical methods used throughout the drug development lifecycle.
• • Contribute to the strategic planning and execution of analytical development strategies, aligning with overall project timelines and regulatory requirements.
• • Evaluate and troubleshoot complex analytical challenges, providing timely and informed solutions to keep projects on track.
• • Uphold the highest standards of quality and attention to detail in all aspects of your work, ensuring data integrity and regulatory compliance.
• • Collaborate with external partners to ensure seamless execution of analytical testing and development activities.
• • Support the development and implementation of new analytical technologies and methodologies as required.
• • Contribute to a culture of continuous improvement within the Analytical Development and CMC functions.
• • This role offers the opportunity to work on cutting-edge rare disease therapies and make a tangible impact on patient lives.
• • You will be part of a team that values curiosity, experimentation, and pushing the boundaries of what's possible in biopharma.
• • The position requires up to 20% travel to support CDMOs and internal meetings.
• • You will be empowered to make decisions and take ownership of your areas of responsibility.
• • Contribute to the overall success of BridgeBio's drug development pipeline by ensuring the quality and analytical integrity of our products.
• • This is an exciting opportunity to leverage your expertise in analytical development within a fast-paced and innovative biotech environment.
• • You will work alongside respected minds in the industry, contributing to the reengineering of the future of biopharma.
• • The role demands a proactive approach to problem-solving and a commitment to scientific rigor.
• • You will be an integral part of a company that is building bridges to groundbreaking advancements for patients with critical unmet medical needs.
• • Your work will directly contribute to bringing novel therapies to market as quickly and efficiently as possible.
• • We encourage a "why not?" mindset, fostering an environment where convention is challenged and innovation thrives.
• • You will be responsible for ensuring that analytical data is accurate, reliable, and supports regulatory filings.
• • This role is critical in bridging the gap between early-stage research and clinical development through robust analytical support.
• • You will have the opportunity to shape the analytical strategies for a diverse portfolio of rare disease programs.
• • The position requires a strong understanding of small molecule chemical characterization and analytical techniques, with a focus on (U)HPLC.
• • You will be expected to critically evaluate data and provide expert scientific judgment.
• • Your leadership will be key in guiding the analytical team and external partners to achieve project milestones.
• • This role is essential for ensuring the quality and safety of BridgeBio's investigational and approved drug products.
• • You will be at the forefront of developing and implementing analytical methods that support regulatory submissions and commercialization.
• • The position offers a unique opportunity to contribute to a company with a strong patient-centric mission and a proven track record of innovation.
• • You will be an integral part of a collaborative and supportive team environment.
• • Your expertise will be crucial in navigating the complexities of GMP compliance and regulatory expectations.
• • This role is ideal for a driven and experienced analytical leader looking to make a significant impact in the biopharmaceutical industry.