The posting
About Site
Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.
Position Summary
We have an opportunity for a Senior Associate Scientist, Biologics III to join our team. In this role, you will be responsible for testing samples, participating in method transfer and validation activities, drafting methods, and reporting data under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies. You will execute laboratory testing using techniques such as mammalian cell culture, sterile technique, in vitro cell-based assays, ELISA assays, molecular biology, kinetic binding assessment, and flow cytometry. This position requires attention to detail, adherence to regulatory compliance, and collaboration within a dynamic team environment.
Shift: M-F 8am-4pm Location: Kansas City, MO 100% Onsite
The Role
- Read and follow Standard Operating Procedures with attention to detail
- Train on 1-2 methods or techniques and perform ad hoc sample testing activities
- Participate with guidance in method transfer and validation activities under cGMP requirements
- Apply basic scientific and laboratory concepts and theories related to specific testing in the group
- Follow cGMP requirements for accurate and thorough documentation to meet regulatory compliance
- Draft technical documents such as methods, method forms, and result reports
- Perform peer review of laboratory notebooks, logbooks, and method forms
- Adhere to policies, processes, and procedures for operating laboratory equipment safely and compliantly
- Understand Catalent culture, programs, and communication processes regarding quality, safety, and ethical practices
- Perform other duties as assigned
The Candidate
Minimum Requirements
- Bachelor’s Degree in Life Sciences or Physical Science with a minimum of 2 years relevant experience in department-specific techniques, OR Master’s degree in related Life Science or Physical Science field with no work experience required
- Applied knowledge of principles and concepts of a discipline such as Biology, Chemistry, or Biochemistry
- Excellent written and verbal communication skills with internal customers, colleagues, and supervisors
- Well organized with ability to multitask and work independently on multiple projects; flexible with daily work schedule
- Ability to work effectively under pressure to meet deadlines
- Strong attention to detail and critical thinking skills
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Preferred Skills & Background
- Previous ELISA and cell-based assay experience preferred
Why You Should Join Catalent
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- Competitive paid time off plus 8 paid holidays
- Community engagement and green initiatives
- Medical, dental, and vision benefits effective day one of employment
- Tuition reimbursement
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 [email protected]. 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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.
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Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.
