Job Description :
Company Overview:
Creating value by bringing together the right people to achieve results is our motto. Our clients and employees say they choose to work with us because of how we work with them - with service that exceeds their expectations and a personal commitment to their success.
Our client, is the world''s largest independent multinational biopharmaceutical company, seeks an accomplished Process Analyst.
Red Flags: Lack of experience with analyzing Large Molecule Biologics from Commercial Manufacturing sites for express purpose of Process Control (i.e. In-process and Statistical
Description:
Contribute directly to Statistical Services and Process Monitoring Re-Design deliverables by providing technical, statistical and analytical expertise.
Learn, interpret and evaluate statistical programming syntax to enable process monitoring of data through the use of analytical software.
Support the identification and implementation of process improvements.
Collaborate cross-functionally with Operations IS, Quality, Regulatory, Process Development, and Manufacturing to ensure changes are implemented according to schedule requirements.
Enable client ownership through statistical reporting and project management for implementation of Enterprise Level platforms and capabilities such as:
o Statistical Process Controls (i.e. nelson rules, cpk/ppk, and anova) through R/SAS/SPSS/Python for all SPC Stakeholders within Operations.
o Analytics across Operations via Data Integration and Sharing systems.
Basic Qualifications:
Master’s degree AND 2 years of Biologics Manufacturing, Engineering, and Operations Process Analytics related experience OR Bachelor’s degree AND 4 years of Biologics Manufacturing, Engineering, and Operations Process Analytics related experience.
Preferred Qualifications:
Degree in Engineering, Computer Science or Business related field.
Proficiency using data analytics software for Large Molecule Biologics, such as Tableau, TIBCO Spotfire, Umetrics SIMCA, and OSIsoft PI.
Knowledge of Drug Substance cell culture purification, Drug Product fill/finish processing and related disciplinary areas.
Experience leading organizational transformation teams as data Subject Matter Experts and instructors.
Experience using project management and scheduling tools.
Understanding of Batch Records, EBRs, LIMS, NC’s and CAPA and use in GMP environment as well as analytical reporting applications.
Background in lean manufacturing methodologies and operational excellence.
Experience participating in and contributing to global, cross-functional teams.
Experience in managing multiple, competing priorities in a fast-paced environment.
Strong communication skills, including technical writing and presentations.
I''d love to talk to you if you think this position is right up your alley.
If you''re looking for rewarding employment and a company that puts its employees first, we''d like to work with you. We''re driven, people driven. We also offer group health Insurance (employee paid on a pre-tax basis
NOTE: “Candidates that are offered a position are required to pass pre-employment drug and background screening”