Senior Associate Scientist I, Molecular & Cellular Biology

Senior Associate Scientist I, Molecular & Cellular Biology

Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.  

Catalent’s Kansas City facility is home to our Clinical Delivery Services and Biologics Analytical Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.  The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring a Senior Associate Scientist I. The Senior Associate Scientist I is primarily responsible for testing samples, participate in method transfer and validation activities, draft methods, and report data under Good Manufacturing Practice (cGMP) regulatory guidance for Large Molecules/Biologics product development and related stability studies.

This is a full-time salaried position: Monday – Friday on 1st shift with core business hours between 8am-4pm. 

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role: 

• Execute laboratory testing using the following techniques as required: Mammalian cell culture, Sterile technique, In vitro cell based assays (e.g., reporter gene bioassay, cell titer glo proliferation bioassay), ELISA assays, quantitative and potency (fluorescence, luminescence, colorimetric, MSD), Molecular biology (e.g., qPCR, PCR), Kinetic binding assessment (e.g., BLI or SPR), and Flow cytometry
• Reads and follows Standard Operating Procedures (SOPs) with attention to detail
• Successfully trains on 1-2 methods and/or techniques mentioned above and perform adhoc sample testing activities and participate with guidance in method transfer and validation activities under cGMP as required
• Applies basic scientific and laboratory concepts and theories related to specific testing in the group
• Follow cGMP requirements for legible, accurate and thorough documentation to meet regulatory compliance; drafts technical documents such as methods, method forms and result reports
• Perform peer review of Laboratory notebooks, logbooks and method forms
• Adheres to policies, processes, and procedures for operating laboratory equipment in a safe and compliant manner
• All other duties as assigned

The Candidate:  

• Bachelor’s Degree in a scientific field is required with a minimum of two years of relevant experience (defined below); will also accept a Master’s degree without any formal work experience
• Must have hands-on application or theoretical knowledge using the following techniques as required: Mammalian cell culture, Sterile technique, In vitro cell based assays (e.g., reporter gene bioassay, cell titer glo proliferation bioassay), ELISA assays, quantitative and potency (fluorescence, luminescence, colorimetric, MSD), Molecular biology (e.g., qPCR, PCR), Kinetic binding assessment (e.g., BLI or SPR), and Flow cytometry
• Must have applied knowledge of the principles and concepts of a discipline (e.g., Biology, Chemistry, Biochemistry) 
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Strong written/verbal communication is required for external and internal stakeholder presentations
• Physical requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision