BBOT · 6 hours ago
Analytical Development Scientist
United States
Full-time
Remote
Senior Level, Lead/Staff
$187K/yr - $211K/yr
8+ years expBBOT is a clinical-stage biopharmaceutical company focused on advancing novel therapeutics for cancer treatment. The Analytical Development Scientist role involves hands-on analytical data review and method lifecycle support for clinical-stage small molecule programs, ensuring compliance with quality standards and collaborating cross-functionally with various departments.
Biotechnology
Responsibilities
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)
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
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
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
Qualification
Required
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
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
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
Benefits
Annual bonus
Stock-based long-term incentives
Medical, dental, and vision benefits
Retirement
Wellness stipend
Flexible time off
Company
BBOT
BBOT (BridgeBio Oncology Therapeutics) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies.
51-200 employees
H1B Sponsorship
BBOT has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase