Bioassay Method Development

• Perform testing to support analytical development manufacturing process development process validations.
• Accurately record data in a timely manner including maintenance of detailed records in compliance with applicable Good Manufacturing Practice (GMP) safety and environmental requirements.  Ensure data integrity and protocol compliance.
• Troubleshoot and execute experiments independently.  Analyze data interpret results and report data in laboratory notebooks.  Collaborate with client to troubleshoot assay problems as they occur.  
• Support regulatory filings including INDs and BLAs.
• Provide technical support (ELISA FRETS Cell based assays Flow cytometry PCR gel electrophoresis and Western blot techniques & other techniques) with development and QC laboratories and support Quality Assurance.
• Ability to handle and maintain various cell lines following aseptic techniques in GMP labs. 

Qualifications :

-Bachelors degree in chemistry biology or a related life sciences

-Strong organization time-management and communication skills

-Strong knowledge or experience working within cGMP guidelines GDP (good documentation practices) and aseptic technique

Additional Information :

Position is full-time Monday-Friday 8 a.m. - 5 p.m. weekend work might be expected. Candidates currently living within a commutable distance of Malvern PA are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Remote Work :

No

Employment Type :

Full-time