Scientist , Molecular & Cellular Biology

Position: Scientist I, Molecular & Cellular Biology
** Scientist I, Molecular & Cellular Biology*
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* Position Summary:

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* Work Schedule:

** Monday - Friday, 8AM - 4:30PM

+ 100% onsite (Kansas City)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our large molecule analytical team has over 25 years of experience providing broad-based and orthogonal analytical CMC services for stand-alone and integrated biologics projects.  We provide support for drug substance, drug product, and intermediates for both innovator and biosimilar/biobetter products.

Catalent Pharma Solutions in Kansas City, MO is hiring a Scientist I in the Molecular and Cellular Biology team. The Scientist I is primarily responsible for method evaluation, optimization, transfer and validation activities under Good Manufacturing Practice (cGMP) regulatory guidance for Large Molecules/Biologics product development and related stability studies. This individual is also responsible for drafting technical documents such as methods, method forms, validation protocols and reports.

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* The Role:

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* + 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 2-4 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

+ Apply complex 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. Draft and review technical documents such as methods, method forms and result reports

+ Perform peer review of Laboratory notebooks, logbooks, methods, method forms, reports, and protocols

+ Adheres to policies, processes, and procedures for operating laboratory equipment in a safe and compliant manner. Understands the Catalent culture, programs, and communication processes regarding quality, safety, and ethical practices

+ All other duties as assigned

** The Candidate:*
* + Bachelor's Degree in a scientific field is required with a minimum of six (6) years of relevant experience (defined below). We will also accept a Master's degree with four (4) years of relevant experience OR a PhD without any formal industry 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

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* 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 requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently

** Why you should join Catalent:*
* + Defined career path and annual performance review and feedback process

+ Diverse, inclusive culture

+ Positive…