Catalent Pharma Solutions Director, Bioassay in Kansas City, Missouri

Job Description

Position Overview:

Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures, packages and distributes pharmaceutical and other products for customers in nearly 100 countries. https://www.youtube.com/watch?time_continue=1&v=65rz3LwTPX8

Job Title

Director, Bioassay

Position Summary

The Director, Biologics will lead the Biologics III group at the Catalent Biologics Kansas City site and is responsible for overseeing various analytical methodologies to characterize and quantify large molecules (excipients, drug substance, drug product) in a compliant manner.

The Role

The methodologies and techniques used in this group are cell-based Potency assays (bioassays or ELISA assays), impurity assays (DNA by qPCR, HCP, Protein A, Insulin, beta glucan, rLongR3), kinetic binding assays or quantitation assays (Octet (BLI) or Biacore (SPR)) and any new assays or new technologies identified and implemented to support industry needs.

The Director will oversee the Biologics III group in the Biologics department in Kansas City. He/she will manage a group of scientists and will be responsible for capacity and scheduling management. He/she will manage the P&L and drive best practices and strategic approaches for group’s assays. ​

The Director, Biologics is critical to the end user which are our patients. ​This leader will need to strongly drive the biologics team in the development and commercial analytical solutions keeping patient safety in mind, executing with efficiency at all times. Leadership, quality, safety and on-time delivery is a must to be successful in this role!

The Candidate

  • Bachelor’s, Master’s 15 years of relevant work in experience in biologics CMC, specific in the cellular and molecular biology area is required or a PhD degree in Biology, Biochemistry, Biotechnology, or related field is required with a minimum of 12 years of relevant work experience in biologics CMC, specific in the cellular and molecular biology area.

  • GMP experience required

  • Experience in developing bioassays

  • Knowledge of Impurity assays (residual DNA by qPCR, HCP, Protein A, Insulin, beta glucan, rLongR3)

  • Some knowledge desired of Kinetic binding assays or quantitation assays by Octet (BLI) or Biacore (SPR)

  • Management experience is required

Position Benefits

  • This is a unique opportunity to join a small, fast-growing business, backed by a global public company.

  • Catalent is aggressively growing in biologics and is making significant investments in people and capabilities in this area.

  • Strong potential for career growth within a growing biopharmaceutical site

  • Working for Catalent Biologics is an opportunity to join an entrepreneurial team that is building a new business.

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 26 days of paid time off annually + 7 paid holidays

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. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities.

Catalent 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!

Grow with us. Be challenged. Make a personal impact.

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 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

Catalent 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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.