Senior Scientist/Associate Scientist

• Bachelor degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field

• 1+ year(s) of direct GMP manufacturing experience or purification experience

Preferred qualifications:

• Thorough knowledge of Good Manufacturing Practices (GMP) regulations

• Thorough knowledge of routine laboratory/plant equipment and demonstrates high level of technical expertise with working familiarity with a number of methods, techniques, laboratory procedures and processes

• Possess in-depth knowledge of how to analyze and interpret experimental/process data

• Demonstrated ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment

• Experience with GE platform of purification equipment and Unicorn software

Details:

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

Key responsibilities include:

• 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

• Completes activities requiring independent thought that have the potential to comprise 50-100% of the employee’s time depending on production campaigns

• 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

• Supports the technology transfer process through active participation in ensuring that new processes fit and execute consistently

• Manages daily activities within the area, including personnel efforts

• Serves as floor lead during preparation and processing activities and potentially as area Supervisor, in the absence of the Supervisor

• May be required to perform cleaning/sanitization of equipment and associated parts utilizing equipment washers, Clean-In-Place (CIP) systems as well as manual cleaning methods, on as-needed basis

• May be required to prepares, assembles and sterilizes via autoclave of equipment and process components, on as-needed basis

• May be required to prepare buffers, including weigh and dispense, formulation, and filtration activities, on as-needed basis

Specific Duties include:

• 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

• Anticipates/recognizes potential problems with equipment and/or supplies, and proactively seeks input from other Scientists to takes action to solve or prevent problems

• 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), Investigation reports, Safety Assessments, and various other protocols with minimal supervision

• Reviews and approves executed load documentation (washer and autoclave), 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

• Maintains and performs compliance checks for documentation in laboratory notebooks, logs, buffer 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

• Performs checks to ensure processing preparedness and facility upkeep

• Provides training and guidance to less experienced manufacturing associates

• Serves as the Equipment Preparation, Buffer Preparation, and Purification Subject Matter Expert (SME)

• Represents the group during cross-functional initiatives, audits, and other

• Trains and mentors less experiences manufacturing associates

Contact information:

You may apply for this position online by selecting the Apply now button.

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