Senior Associate Scientist II, BioChemical Analysis

Catalent•Kansas City, MO

3d•Onsite

About The Position

Senior Associate Scientist lI, Biochemical Analysis 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 ll in Biochemical Analysis. The Senior Associate Scientist I will primarily test samples, participate in method transfer and validation, draft methods, and report data under Good Manufacturing Practice (cGMP) regulatory guidance for Large Molecules/Biologics product development and related stability studies. The Role: Execute laboratory testing using the following techniques as required: Compendial assays (e.g. appearance. pH, Osmolality, Particulate measurements, Viscosity), Karl Fischer, UV-Vis, Chromatography techniques/methods (e.g. H/UPLC, SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis), Aggregation techniques (e.g. MFI, AUC, SEC-MALS), Capillary and Gel Electrophoresis (e.g. CE-SDS, SDS-PAGE, icIEF, IEF, western blot) and testing with FTIR, Intrinsic Fluorescence, Differential Scanning Calorimetry 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

Requirements

Bachelor’s Degree in Life Sciences or Physical Science field with minimum of 4 years relevant experience in department specific techniques
Master’s degree in related life science or physical science field required with a minimum of 2 years relevant experience in department specific techniques
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), Karl Fischer, UV-Vis, Chromatography techniques/methods (e.g. H/UPLC, SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis), Aggregation techniques (e.g. MFI, AUC, SEC-MALS), Capillary and Gel Electrophoresis (e.g. CE-SDS, SDS-PAGE, icIEF, IEF, western blot) and testing with FTIR, Intrinsic Fluorescence, Differential Scanning Calorimetry

Responsibilities

Execute laboratory testing using the following techniques as required: Compendial assays (e.g. appearance. pH, Osmolality, Particulate measurements, Viscosity), Karl Fischer, UV-Vis, Chromatography techniques/methods (e.g. H/UPLC, SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis), Aggregation techniques (e.g. MFI, AUC, SEC-MALS), Capillary and Gel Electrophoresis (e.g. CE-SDS, SDS-PAGE, icIEF, IEF, western blot) and testing with FTIR, Intrinsic Fluorescence, Differential Scanning Calorimetry
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.