Catalent Pharma Solutions Senior Scientist in Morrisville, North Carolina

Job Description

Job Title

Senior Scientist

Position Summary

The role supports Catalent’s Inhalation product development function from product definition up to commercialization. The ideal candidate would have strong technical and regulatory understanding (i.e. NDA, ANDA, 505b2) of inhaled product development (or similar pharmaceutical dosage forms) and would be expected to support inhalation development projects across a potential range of inhaled delivery platforms (MDI, Nasal, DPI, nebulizers, etc.). This individual would have the ability to provide support in developing scope, analyzing, interpreting, and effectively communicating results of drug product development experiments and product characterization studies, while managing these activities to customer timelines. The candidate must have the ability to provide direct oversight to multidisciplinary team of 3 – 5 development scientists.

The Role

Provide guidance on the development, oversight, and execution of complex technical deliverables for the development of inhaled drug product using both internal and external resources.

Ability to effectively communicate technical progress to senior internal and external stakeholders both through written and oral communications.

Work and communicate effectively with other functional groups and across global respiratory R&D sites. Liaise with internal and external (contract development, manufacturing, and analytical) departments to achieve project targets.

Establish and maintain effective and functional team.

Should possess knowledge of one or number of areas such as analytical methods, formulation, container-closure systems, device design, and manufacturing processes.

Working knowledge of applicable global regulatory requirements desired

Knowledge of FDA requirements (essential), understanding of other regulators (MHRA, EMEA, desirable).

The Candidate

Education or Equivalent: Doctorate’s degree with more than 4 years related experience or, Master’s degree with more than 8 years related experience, or Bachelor’s degree with more than 10 years related experience

Experience and prior use of risk analysis tools and their application.

Experience and prior use of statistical analysis tools, especially experimental design (DoE)

Prior experience with regulatory submissions (NDA, ANDA, 505b2) a plus

Experience with CFR 820 combination device regulations

Strong analytical skill set desired

PLUS: Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

• Leads with Integrity and Respect

• Delivers Results

• Demonstrates Business Acumen

• Fosters Collaboration and Teamwork

• Champions Change

• Engages and Inspires

• Coaches and Develops

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.