- 190151 - Scientist I
- St. Louis
- Up to $25.00 DOE
- 8 mos
- Chipton-Ross is seeking a Scientist I for an opening in St. Louis, MO.
This person will develop a core competency in process validation and processes from the GMP scale production during late phase clinical runs through PPQ campaigns, and commercial campaigns, as well as identifying and leading technical investigations and providing technical advisement to Manufacturing Technical Support engineers. In this role you will contribute to process validation milestones through analysis and mining of batch data and ensuring successful execution on the floor.
This role will report to and receive mentorship from a Senior Engineer, Supervisor, or Manager. This role is expected to require a high degree of oversight from supervision, while still being able to self-motivate and work autonomously.
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 SOP’s. 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.
1-2 years of Biotech industry experience in commercial scale manufacturing operations preferred. 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.
Accredited Bachelor’s degree in Chemical or Mechanical Engineering or Life Sciences. Other engineering or science degree considered based on relevant work experience.
M-F, 40hr weeks, 8 – 4PM
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.