Lead Scientist I, Molecular & Cellular Biology

Catalent•Kansas City, MO

1d•Onsite

About The Position

Lead Scientist I, Molecular & Cellular Biology 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 Lead Scientist I in the Molecular and Cellular Biology team. The Lead Scientist I is primarily responsible for assay generation, design, development, and validation efforts for Biopharma product development under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies. Also responsible for drafting, reviewing, and approving technical documents such as SOPs, methods, method forms, validation protocols and reports.

Requirements

Bachelor’s Degree in a scientific field is required with a minimum of 11 years of relevant experience (defined below). We will also accept a Master’s degree with 9 years of relevant experience OR a PhD with 5 years of relevant 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
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

Nice To Haves

Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

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
Become SME on 4-6 methods and/or techniques mentioned above and perform 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
Mentor, coach and train peers on cGMP compliance, methods and laboratory instruments and equipment.
Lead CSV activities within the group
Follow cGMP requirements for legible, accurate and thorough documentation to meet regulatory compliance.
Mentor junior colleagues in good documentation practices
Lead in drafting, review and approve technical documents such as SOPs, methods, method forms, validation protocols and reports with minimal guidance
Perform and co-ordinate peer review of Laboratory notebooks, logbooks, methods, method forms, reports and protocols
Instruct colleague on policies, processes, and procedures for operating laboratory equipment in a safe and compliant manner.
Becoming familiar with drug development milestones and their context
Support in design of scope of work for proposals and track any change in scope for the duration of the project
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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