Senior Associate Scientist I

Catalent•Kansas City, MO

12h•Onsite

About The Position

Position Summary: 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 Senior Associate Scientist I. The Senior Associate Scientist I will primarily test 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.

Requirements

Bachelor’s Degree in a scientific field is required with a minimum of two years of relevant experience (defined below). We 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 requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently

Responsibilities

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. Understands the Catalent culture, programs, and communication processes regarding quality, safety, and ethical practices
All other duties as assigned

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 Hours + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match
Company match on donations to organizations
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement – Let us help you finish your degree or start a new degree!
WellHub program to promote overall physical wellness
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