The Associate Scientist assists the manufacture of clinical supply of investigational biopharmaceutical molecules. Specifically, hands-on cGMP manufacture of mid to large scale purification of bulk drug substance for use in early phase clinical trials.

Must be available to work off-shift hours: early mornings, late evenings/nights, and weekends if necessary

The key responsibilities of the role include the following:

• Performs hands-on processing of large-scale purification steps under cGMP regulatory conditions. Processing steps include: Column packing, Chromatography, UltraFiltration/DiaFiltration, Depth Filtration, Bulk Drug Fill
• Executes and overseas production of clinical supplies based on established scientific procedures and protocols and implements improvements with minimal supervision; interprets data and draws conclusions from the data
• Completes activities requiring independent thought that have the potential to comprise 50-100% of the employee’s time depending on production campaigns
• Supports the technology transfer process through active participation in ensuring that new processes fit and execute consistently
• Performs cleaning/sanitization of equipment and associated parts utilizing equipment washers, Clean-In-Place (CIP) systems as well as manual cleaning methods
• Prepares, assembles and sterilizes via autoclave of equipment and process components
• Prepares buffers, including weigh and dispense, formulation, and filtration activities
• 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
• Assist with the manufacture of clinical supply of investigational biopharmaceutical molecules.   Specifically: hands-on cGMP large scale cell culture, manufacturing, 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

This role will provide YOU the opportunity to lead key activities to progress YOUR career. The responsibilities of the role include the following:

• Leads or works on projects and assignments where independent action and a high degree of initiative and knowledge are required for execution or to provide recommendations
• Anticipates/recognizes potential problems with equipment and/or supplies, and proactively seeks input from other Scientists to take action to solve or prevent problems
• Represent the group during cross-functional initiatives
• Serve as Subject Matter Expert (SME)
• Train and mentor less experienced manufacturing scientists
• Recognizes potential safety and compliance problems and takes action to rectify
• Troubleshoots problems in the execution of processing activities; proactively assesses options and impact and takes action to rectify or communicate to appropriate decision makers
• Authors Standard Operating Procedures (SOPs), Safety Assessments, and various other protocols with minimal supervision
• Reviews and approves executed documentation, Buffer Forms, and/or Batch Records prior to submission to Quality Assurance (QA) to insure adherence to cGMPs and proper documentation practices
• Leads deviation investigations and implementation of CAPAs stemming from Safety or Compliance observations
• Identifies process improvement opportunities with impact on safety, compliance, and efficiency/cost

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree Chemical Engineering, Biology, Chemistry, or other engineering or scientific field with 1+ year of experience in a lab/manufacturing setting (including internships, co-ops, etc.)
• Experience working with GMPs
• Experience working in downstream or upstream manufacturing

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience in a Good Manufacturing Practices (GMP) environment
• Large-scale downstream manufacturing experience
• Thorough knowledge of routine laboratory/plant equipment and demonstrates high level of technical expertise with working familiarity with a numb