Lead Scientist I, Molecular & Cellular Biology

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.

The Role: 

• 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

The Candidate:  

• 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
• 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
• 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 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.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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