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BioPhase

Senior Scientist

BioPhase, San Francisco, California, United States, 94199

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This range is provided by BioPhase. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range

$130,000.00/yr - $155,000.00/yr This position is located in San Diego and relocation assistance is available for well qualified candidates. Sr. Scientist-ANALYTICAL DEVELOPMENT & QUALITY CONTROL Seeking an experienced analytical chemist to join our QC & Analytical Development group at the Sr. Scientist level. The ideal candidate will be a self-starter, familiar with a broad range of analytical techniques, possess a strong work ethic, have good communication skills, and have experience working in a GMP environment. The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail. RESPONSIBILITIES: Coordinate and execute testing of drug substance intermediate, drug substance, and drug product samples Develop drug substance specifications ensuring efficient integration across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology Author scientific reports and portions of the CMC section of regulatory filings Manage the analytical activities for therapeutic development projects May develop and optimize analytical methods Design and execute method validation and method transfer protocols Manage outsourced analytical activities at external contract labs Conduct analytical investigations Present at internal and cross-functional scientific meetings REQUIREMENTS: MS with at least 10 years of industry experience in Analytical Chemistry or related discipline Ph.D. with at least 5 years of industry experience in Analytical Chemistry or a related discipline Skilled in operating LC-MS, HPLC, and GC for the analysis of drug substance and drug product samples Good understanding of the drug development process Practical knowledge of GMP requirements, with hands-on GMP experience preferred Good understanding of ICH and FDA method validation guidelines, including phase-appropriate strategies Ability to problem solve, manage priorities and maintain aggressive timelines for multiple projects Ability to work productively and independently within a team or matrix environment Good written and verbal communication skills Seniority level

Seniority level Mid-Senior level Employment type

Employment type Full-time Job function

Job function Quality Assurance and Research Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at BioPhase by 2x Inferred from the description for this job

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