Senior Scientist

BioPhase

San Francisco (CA)

On-site

USD 130,000 - 155,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Relocation assistance

Job summary

Join a forward-thinking company as a Sr. Scientist in Analytical Development & Quality Control. This role offers the opportunity to lead analytical testing and method development for drug substances and products. You will collaborate with cross-functional teams to ensure compliance with GMP standards while authoring critical regulatory documents. Ideal candidates will have extensive experience in analytical techniques such as LC-MS and HPLC, and a deep understanding of the drug development process. If you're looking to make a significant impact in a dynamic environment, this position is perfect for you.

Qualifications

10+ years in Analytical Chemistry or related field required.
Experience with GMP and FDA method validation guidelines.
Ability to work independently and manage multiple projects.

Responsibilities

Coordinate testing of drug samples and develop specifications.
Author scientific reports and manage analytical activities.
Conduct analytical investigations and present findings.

Skills

Analytical Chemistry

LC-MS

HPLC

GMP Requirements

Problem Solving

Communication Skills

Education

MS in Analytical Chemistry

Ph.D. in Analytical Chemistry

Tools

LC-MS

HPLC

Job description

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