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Quality Control Associate Scientist II

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacturing. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

The Catalent site in Kansas City, MO is hiring a Quality Control (QC) Associate Scientist II. The QC Associate Scientist II performs tasks from detailed instructions and established procedures. This person will learn and comply with site Standard Operating Procedures (SOPs), corporate policies, and Environmental Health and Safety requirements. You will use basic knowledge of the principles and concepts of Biology & Chemistry for testing purposes. We’re seeking a self-motivated, detail-oriented person who is able to make decisions and solve problems independently or in a team environment.

This is a full-time on-site hourly position: Monday-Friday on 1st shift with general hours between 8am-4:30pm. Overtime/weekends support periodically on as needed basis.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role:

+ Sample types include U.S., Japanese, and European Pharmacopoeia release testing and stability testing. Techniques include but not limited to: sterility, bioburden and microbial limits testing, or endotoxin testing

+ Execute laboratory work plan / schedule developed with input from supervisor or senior team member

+ Maintain high quality documentation in accordance with applicable regulatory guidance and site SOPs documenting work as appropriate within notebooks, forms, etc.

+ Execute procedures or methods of moderate and potentially advanced complexity with high quality and reviews own work to ensure accuracy and completeness. Able to identify and remediate minor quality/compliance gaps during lab work

+ Draft technical documents such as methods or certificates of analysis with little to no guidance from a supervisor or senior team member

+ Perform peer review of routine laboratory documentation. May review technical documents for accuracy and thoroughness

+ Trains others on basic lab techniques. Assist in the execution of efficiency/compliance improvement projects with guidance

+ Other duties as assigned

The Candidate:

+ Bachelor's degree in related life science or physical science field required (Biology or Microbiology preferred)

+ No formal work experience is required, but it is highly preferred to have hands-on microbiology testing using aseptic technique

+ Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to identify aberrant/out of spec data and limited interpretation of data expected

+ Basic understanding of instrument operations and troubleshooting skills in multiple techniques

+ Proficient on lab-related Good Manufacturing Practices (GMPs)

+ **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. May require the use of a respirator

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 (https://careers.catalent.com/us/en) 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.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .