Senior Scientist Job at BioPhase, San Francisco, CA

OXpJM0JsbXBBWm0wZVlnamdRNlVpUzQ1
  • BioPhase
  • San Francisco, CA

Job Description

This position is located in San Diego California. You must be open to relocation to San Diego if you are interested in this role!

Seeking an experienced analytical chemist to join our AD/QC group at the Sr. Scientist or Assistant Director 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.

PRIMARY 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 oligonucleotide 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:

  • BS or MS with at least 5 years (Sr. Research Associate) or 10 years (Assistant Director) of industry experience in Analytical Chemistry or related discipline
  • Ph.D. with at least 2 years (Sr. Scientist) or 7 years (Assistant Director) 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

Job Tags

Contract work, Relocation,

Similar Jobs

StatRad

Administrative Assistant Job at StatRad

 ...JOB REQUIREMENTS AND SKILLS Must be able to work independently at night from your own home office/environment. Provide administrative and organizational support to the radiologists and clients. Must be computer literate in multiple disciplines and able to... 

Excentia Human Services

Behavioral Health Technician Job at Excentia Human Services

 ...with play-based, person-centered treatment goals (not compliance-based models) Enjoy a flexible scheduleMonday through Friday, 9 AM to 6 PM, with optional Saturday sessions What Were Looking For: A compassionate, energetic, and open-minded team member Willingness... 

Excellence Services, LLC

Butler / Personal Assistant Job at Excellence Services, LLC

Butler/Personal Assistant We are seeking a Butler/Personal Assistant to join a dynamic, high-end private household. This role requires direct involvement in both managing and assisting in various household operations, requiring a balance of humility and service-driven...

Nesco Resource

Analytical Quality Assurance Analyst I Job at Nesco Resource

 ...Analytical Quality Assurance Analyst I Responsibilities Perform in-process testing (e.g. weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Conduct room and equipment checks (where applicable... 

Apexon

Software Tester Job at Apexon

 ...presence of 15 offices (and 10 delivery centers) across four continents. We enable #HumanFirstDIGITAL Position Summary The QA engineer role is responsible to manage all aspects of user acceptance testing and the quality assurance lifecycle pertaining to the...