Catalent Pharma Solutions Group Leader, Biologics in Kansas City, Missouri

Job Description

Job Title

Group Leader, Biologics

Position Summary

The main activities will be to provide and report data, as required by project contracts within the Biologics Department. The data may be used for submission in Regulatory packages, release and stability testing of clinical and animal trial dose forms and in support of development projects.

About Catalent Biologics:

Catalent Biologics is a fast growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI., and our market leading biologics analytical services in Kansas City and Research Triangle Park, NC. With the recent acquisition of Redwood Bioscience in Emeryville, CA, we have added the SMARTag Antibody Drug Conjugate technology, providing a next-generation ADC platform to our biologics customers. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team that is building a new business. Catalent is aggressively growing in biologics, and is making significant investments in people and capabilities in this area. This is a unique opportunity to join a small, fast growing business, backed by a global public company. People joining our team will also have significant career development/progression opportunities as our business continues to grow and expand.

The Role (daily responsibilities)

  • CMC/GMP knowledge/experience/expertise in 1) implementation of method through method development, method qualification/validation, method transfer, 2) testing for GMP and characterization, and 3) troubleshooting for the following assay types:

  • Expertise in Cell based Potency assays such as bioassays or ELISA assays, good knowledge of Impurity assays such as residual DNA by qPCR, HCP, Protein A, Insulin, beta glucan, rLongR3, and others as needed.

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

  • Implementation of other assays that are appropriate for testing support from this group including new and niche assays/technology and novel science

  • Must have well-developed human relations skill and be able to apply in advance, a combination of knowledge, imagination, judgment, and realistic appraisal in project evaluations. Must possess good to excellent writing and PC skills. A knowledge base in Microsoft Word, Excel, Power Point, and Microsoft Projects is desirable.

  • Candidate must have working understanding of pharmaceutical formulation systems, cGMP’s, and regulatory issues as they apply to technology transfer.

  • Supervise and coordinate activities of a team of Scientists, Senior Scientists and/or Associates within Biologics III group

  • Plan, prioritize, organize and execute the conduct of analytical work in accordance with the requirements of the client contract and/or technical agreement.

  • Assure the integrity and quality of analytical data produced by ensuring staff are adhering to all relevant in-house and client SOPs and methodologies and following the requirements of GMP.

The Candidate (requirements)

  • Degree in life sciences such as chemistry, biochemistry, biology or closely related physical science.

  • Bachelors Degree: >15 years of relevant experience preferred

  • Masters Degree: >12 years of relevant experience preferred

  • Doctorate Degree: >10 years of relevant experience preferred

Position Benefits

  • 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

About Catalent

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities, or contact us at

+1 877 503 9493.

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.

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 offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

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.