PDS Tech Inc Scientist I in Saint Louis, Missouri
PDS Tech, Inc. is seeking a Scientist I
What will you do?
Summarize, evaluate and verify protocol data, including resolution of discrepancies and exceptions as required for completion of validation summary reports.
Write, revise and execute validation protocols and reports for processes and unit operations following the requirements of project specific Process Validation Plans, site and company policies, and departmental SOPs.
Compile and perform statistical analysis of commercial batch data.
Perform the technical review on site documents such as deviations, change controls, and batch records.
Perform process monitoring (manufacturing data summary and analysis, data presentation) and analysis of lot release data as it applies to PV studies.
Actively drive improvements for PV, OPS, and MTS practices and procedures.
Assist with CAPA and Deviations with some oversight to achieve quality, timely results.
How will you get here?
Bachelors degree in Chemical or Mechanical Engineering or Life Sciences. Other engineering or science degree considered based on relevant work experience.
1-2 years of Biotech industry experience in commercial scale manufacturing operations preferred
Knowledge, Skills, Abilities
Strong written and oral communication skills.
Demonstrates a solid foundation in general scientific practices, principals and concepts.
Ability to work both independently and in a team environment.
Ability to self-motivate, prioritize work and time and work on multiple projects effectively.
Excellent organizational skills and problem-solving abilities.
Proficiency in Microsoft Word and Excel. Working knowledge of controlled documentation systems and LIMS sample management system preferred.
Basic knowledge of statistical analysis (control charts, process capability, process control) and familiarity with a mainstream statistical software analysis program such as SAS, MiniTab, JMP.
Basic understanding of pharmaceutical processing and GMP practices.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.