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.
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.
- 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
- 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