Manager/Senior Manager, Analytical Chemistry

About BridgeBio Oncology Therapeutics

BridgeBio Oncology Therapeutics (BBOT) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. Initially formed as a subsidiary of BridgeBio Services, BBOT completed a $200M private financing with external investors in 2024 with the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. 

For more information visit bridgebiooncology.com.

Job Title: Manager / Senior Manager, Analytical Chemistry

Job Summary:
The Manager/Senior Manager of Analytical Chemistry will be responsible for supporting the development and tracking of stage-appropriate testing methodology for drug substances and drug products for multiple clinical programs. The ideal candidate will possess expertise in analytical chemistry techniques and experience working with teams to deliver high-quality, compliant analytical data. This role will play a key part in the development, validation, and execution of analytical methods, ensuring that products meet required specifications and quality standards. The position will directly report to the Associate Director/Director of Analytical within the Chemistry, Manufacturing, and Controls (CMC) department and collaborate cross-functionally with Clinical Supply, Toxicology, Regulatory Affairs, and Quality Assurance/Quality Control.

Key Responsibilities:

1. Analytical Data Review and Interpretation:
• Review and interpret high performance liquid chromatography, gas chromatography, various spectroscopy techniques, and physicochemical properties data (solubility, solid state, physical testing) for raw materials, intermediates, and drug product.
• Draft and maintain internal documents related to project data. Keep contemporaneous and organized data tracking and forecasting tools.
• Support any investigations or optimizations needed to support the long-term goals of the programs and collaborate with QA colleagues to ensure appropriate documentation in the record(s).
2. Analytical Method Development and Validation:
• Oversee and support the development, validation, and troubleshooting of analytical procedures and specifications for raw materials, intermediates, finished products, and stability studies in compliance with regulatory guidelines. Provide scientific and technical corrections and guidance to ensure quality and accuracy, while meeting project timelines.
• Must have advanced understanding of analytical techniques, technology, theory, and application to adequately troubleshoot and optimize critical quality indicating methods.
3. Cross-functional Collaboration and Communication:
• Collaborate cross-functionally with R&D, manufacturing, quality assurance/control, and regulatory teams to ensure timely and accurate delivery of analytical results.
• Provide regular updates to CMC management on the status of analytical testing activities, and any potential risks from interpretation of the data, or timeline.
• Using a thorough understanding of Analytical techniques and Regulatory guidelines, use a risk-based approach for decision making with the goal of first-pass approval and/or no comments in filings and amendments.
4. Vendor Management:
• Manage and nurture relationships with external vendors, including manufacturers, development centers, and contract testing facilities.

• May be called on to support Chemistry and Quality in the selection and qualification of third-party suppliers and service providers.

Qualifications:

• BS., MS., or PhD. in Organic Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or closely related field.

• Possess at least 5+ years’ GMP Analytical bench chemistry experience in development, validation, and testing for drug substances and solid oral dosage forms for common tests such as Identification, Assay, Impurities (Solvents, Organic, Elemental), Dissolution, Identification, Crystallinity, Particle Size, MLT, etc.

• Possess at least 8+ years’ experience in GMP pharmaceuticals to include small molecule, solid oral dosage forms.
• Strong knowledge of cGMP regulations, compendia (USP, EP, JP), and FDA, MHRA, ICH guidelines, etc as they apply to specification setting and justification.
• Proven experience in method development, validation, and troubleshooting

• Ability to understand and interpret chemical structures through collaboration with synthetic chemists.

Skills:

• Excellent communication, interpersonal, and organizational skills.
• Must be a self-starter and maintain activities without direct supervision.
• Strong problem-solving abilities and attention to detail.
• A strong candidate will be familiar with Project Management and/or Lean Six Sigma techniques to be able to forecast, communicate, and mitigate risks to timelines as well as identify and support continuous improvement initiatives.
• Strong proficiency in Microsoft Excel, Word, and PowerPoint to gather, tabulate, interpret, and present data efficiently and professionally.
• Ability to handle multiple tasks and prioritize effectively in a fast-paced environment.

Additional Information:

• Occasional travel may be required, both domestic and international.
• Work Environment: Remote Position