Principal Associate

BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Principal Associate to work for a leading San Diego biotechnology company.


Principal Associate

Summary:
The Principal Associate position will perform release and stability testing of pipeline candidates in support of development programs.  n addition, the candidate will participate in studies focused on qualifying/validating and transferring analytical methods. Experience working in a GMP laboratory environment, as well as familiarity with analytical requirements for parenteral and oral products is required. Experience with chemical and biomolecular methods, including cell-based, immunological, and molecular biological assays, as well as standard laboratory techniques is also required. 

Responsibilities:
  • Perform in-process, release, and stability testing following approved standard operating procedures (SOPs) and test methods
  • Qualify, validate, and transfer analytical methods for testing drug substance and drug product with guidance from management
  • Participate in the preparation of protocols, reports, test methods, and SOPs 
  • Maintain accurate and complete laboratory notebooks, logs/logbooks, and records following GXP documentation practices
  • Conduct and document investigations following SOPs and GXP guidelines; initiate and close deviations, CAPAs, and change requests
  • Follow SOPs and laboratory guidelines for daily operation of GXP laboratories
  • Author and review analytical data summaries to support batch release and stability assessments for clinical materials
  • Assist in maintaining inventories of chemicals, reagents, and reference materials
  • Perform routine maintenance, calibration and qualification of laboratory equipment and instrumentation
  • Maintain training record per GXP and company training requirements
  • Develop presentations to communicate information to internal groups and management

Requirements:
  • Associate’s degree in chemistry, biology, or related field and 10+ years of related experience, or a BA/BS degree and 5 to 8 years of related experience
  • Good understanding of regulatory requirements, including FDA/EMA, GMP, ICH, USP/EP 
  • Excellent written and verbal communication skills
  • Strong work ethic with solid organizational, time management, decision-making, and interpersonal skills
  • Familiarity with standard laboratory techniques, including Karl Fisher, pH determination, spectroscopic methods, HPLC, etc.
  • Basic computer skills, including MS Word, Excel, etc.
  • Strong troubleshooting skills
  • Ability to prioritize assignments and complete work in a timely manner
  • Demonstrated ability to think and act independently and in a team and accept supervision and guidance
  • Demonstrated ability to work quickly and accurately in a fast-paced environment, critically analyze data, and proactively solve problems
  • Ability to negotiate and deal with others in a constructive manner 
  • Ability to effectively document and communicate results
  • Location: San Diego
  • Type: Permanent
  • Job ID: RH969187517