Bachelor degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field. May have at least 1+ year(s) of direct GMP manufacturing experience or upstream experience
Familiarity with Good Manufacturing Practices (GMP) regulations
Operational knowledge of routine laboratory/plant equipment
Must be available to work off-shift hours: early mornings, late evenings/nights, and weekends if necessary
Demonstrates good interpersonal skills, is attentive and approachable. Maintains a professional and productive relationship with area management and co-workers
Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment
Assist with the manufacture of clinical supply of investigational biopharmaceutical molecules. Specifically: hands-on cGMP large scale cell culture or microbial fermentation for use in early phase clinical trials
Performs hands-on processing of large scale cell culture or microbial steps under cGMP regulatory conditions. Processing steps include: Small scale/scale-up from vial thaw, end of production, media preparation, operation of stainless steel and single use bioreactors, harvest operations, CIP, SIP, washer and autoclave operation
Completes activities requiring independent thought that have the potential to comprise 50-100% of the employee's time depending on production campaigns
In addition to manufacturing responsibilities, works on projects and assignments where independent action and a high degree of initiative are required in order to resolve problems and make recommendations
Executes production of clinical supplies based on established procedures and protocols and implements improvements with minimal supervision; interprets data and draws conclusions from the data
Anticipates/recognizes potential problems with equipment and/or supplies, and takes action to solve or prevent problems
Recognizes potential safety and compliance problems and takes action to rectify or escalate
Troubleshoots problems in the execution of processing activities; proactively assesses options and impact and communicates to the appropriate decision makers
Authors Standard Operating Procedures (SOPs), Investigation reports, Safety Assessments, and various other protocols with minimal supervision
Reviews executed load documentation (washer and autoclave), Media Forms, and/or Batch Records prior to submission to Quality Assurance (QA) to insure adherence to cGMPs and proper documentation practices
Identifies process improvement opportunities with impact on safety, compliance, and efficiency/cost
Documents work performed via the use of logs, media forms, batch records, and electronic systems in accordance with company policy and legal requirements
Strives for Right First Time in the manufacture of investigational material through attention, focus, planning, and adherence to procedural and regulatory expectations
Attends to regular safety and cGMP training: maintains accurate and complete safety and role-specific training records, consistent with company policy and legal requirements
Provides training and guidance to less experienced manufacturing associates
Serves as Subject Matter Expert (SME) in small scale, media preparation, or large scale operations
May be asked to serve as lead in the absence of area supervisor or senior scientist
You may apply for this position online by selecting the Apply now button.
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