Catalent Pharma Solutions Quality Control Lead Scientist in Kansas City, Missouri
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
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 manufacture.
The Quality Control Lead Scientist works with minimum supervision, conferring with superior on unusual matters. He/she is usually assisted by laboratory technicians/associates. He/she demonstrates potential for technical proficiency and scientific creativity through broad assignments. The Quality Control Lead Scientist has appreciable latitude for un-reviewed action or decision. He/she may be responsible for setting and defining technical objectives and assessing results. The Quality Control Lead Scientist complies with divisional and site Environmental Health and Safety requirements.
Develop and oversee laboratory work plans/schedules for self and junior members of team, using customer milestones and Division/Site performance standards and metrics. Sample types include in-process, release or stability. Techniques include HPLC, GC, Karl Fischer, Disintegration, Dissolution, ICP-MS, FTIR, particle size and appearance. Guide method transfer activities.
Responsible as Project Technical Lead with responsibility for project outcome and customer interaction
Authors and may approve technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures
Review technical documents for accuracy, thoroughness and regulatory compliance
Trains, coaches or mentors others on technical, personal development or business issues
Supervises technical staff, including work assignments and performance management
Develop and execute efficiency improvement projects
Identify and recommend business opportunities on project specific basis
Education or Equivalent: Degree in chemistry or closely related physical science.
Experience: Bachelor's degree with 9 - 10 years related experience, equivalent education, experience and training; Master's degree with 6 - 8 years related experience, equivalent education, experience and training; OR Doctorate Degree with 2 – 4 years related experience.
Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
Internal expert on data interpretation, applications, instrumentation and theory in at least one area of expertise.
Consistently provides accurate data within the framework of regulatory guidance.
Evaluate and assess impact of proposed changes to controlled documents and/or project scope
Propose deviations from established procedures and methods based upon sound judgment.
Based on broad technical skills and drug development experience, anticipates and identifies unmet customer needs.
Understands the elements of a regulatory CMC filing package and the analytical documentation required therein.
Catalent’s standard leadership competencies
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Medical, Dental, Vision and 401K are all offered from day one of employment
19 days of paid time off annually
Potential for career growth within an expanding team
Defined career path and annual performance review and feedback process
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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.Visit www.catalent.com/careers to explore career opportunities.
C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.
Catalent = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
personal initiative. dynamic pace. meaningful work.
Catalent is the perfect place to grow your career if…
You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!
You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking (https://catalent.wd1.myworkdayjobs.com/External) for YOU!
See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .