Senior Associate Scientist I, Commercial Testing

Catalent•Kansas City, MO

10d•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 in Commercial Testing who will primarily be responsible for late-stage transfer and validation activities under Good Manufacturing Practice (cGMP) regulatory guidance for Large Molecules/Biologics product development, release and related stability studies. You will participate in drafting technical documents such as methods, method forms, validation protocols and reports.

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 basic knowledge of the principles and concepts of a discipline (e.g., Biology, Chemistry, Biochemistry)
Ability to work effectively under pressure and use critical thinking to meet deadlines. 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

Nice To Haves

Preferred hands-on application or theoretical knowledge using the following techniques: Compendial assays (e.g. appearance. pH, Osmolality, Particulate measurements, Viscosity), In Vitro cell based potency methods, UV-Vis, Chromatography techniques/methods (e.g. H/UPLC, SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis), ELISA assays, quantitative and potency (e.g. fluorescence, luminescence, colorimetric, MSD), Capillary and Gel Electrophoresis (e.g. CE-SDS, SDS-PAGE, icIEF, IEF, western blot) and flow cytometry

Responsibilities

Execute laboratory testing using the following techniques as required: Compendial assays (e.g. appearance. pH, Osmolality, Particulate measurements, Viscosity), In Vitro cell based potency methods, UV-Vis, Chromatography techniques/methods (e.g. H/UPLC, SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis), ELISA assays, quantitative and potency (e.g. fluorescence, luminescence, colorimetric, MSD), Capillary and Gel Electrophoresis (e.g. CE-SDS, SDS-PAGE, icIEF, IEF, western blot) 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 performs adhoc sample testing 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. Supports drafting of simple methods, method forms and result reports
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
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.