Manager/Senior Manager, CMC Analytical

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BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. 

To learn more, visit us at https://bridgebio.com

Location

San Francisco, CA

Who You Are

We are looking for an experienced analytical Manager/Sr Manager to join our expanding CMC team and work for multiple affiliates, including a targeted oncology program. This position will work directly with our Director of CMC and oversee CDMOs to manage analytical development and quality control activities on multiple programs. If you have a complete understanding of GMP requirements and experience working on various drug development phases, we would love to hear from you!

Responsibilities

  • Oversee contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for drug substance (DS) and drug product (DP)
  • Manage analytical documentation (i.e., CofA, test methods, protocols, reports,  specifications, stability, and raw data) within Quality Management System (QMS)
  • Manage DS and DP stability programs and corresponding shelf-life determinations
  • Regularly and clearly communicate Analytical Development and QC topics both verbally and in visual presentation form, efficiently and contextually.
  • Support and author analytical content for CMC Regulatory for US and Rest of World dossiers
  • Support Quality Assurance audits, as a QC subject matter expert, as needed
  • Provide on-site technical support on an as-needed basis to oversee various manufacturing/scale-up/validation activities. Provide technical expertise to troubleshoot manufacturing/packaging process issues.
  • Interface effectively with other CMC team members (e.g., Process Chemistry, Formulation Development, Quality Assurance, Supply Chain, etc.).

Education, Experience & Skills Requirements

  • MS with five years or BS with seven years of relevant analytical chemistry experience
  • Oversite of external QC laboratories (e.g., method development, method validation & troubleshooting analytical procedures)
  • Experience with stability and shelf-life management
  • Practical working knowledge of ICH guidance
  • Knowledge of small molecule chemical characterization techniques
  • Broad understanding of analytical techniques, with a focus on (U)HPLC
  • Hands-on GMP experience with all phases of drug development, as well as in-depth knowledge and complete understanding of GMP requirements
  • Ability to critically evaluate and troubleshoot complex problems while offering timely and informed options for resolution
  • Strong verbal & written communication skills, with the ability to effectively interact with and influence different functional groups across all levels of management
  • Position requires up to 20% travel
  • Strong focus on quality and attention to detail

What We Offer

  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
  • A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
careers

Manager/Senior Manager, CMC Analytical

Apply Now