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Catalent Pharma Solutions Senior PBPK Advisor in Kansas

Job Description

Position Overview:

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)

Position Summary:

Catalent is looking to hire a Senior PBPK Advisor to join a dynamic Science & Technology team. This role will be a remote opportunity with a preference of being located proximal to one of Catalent’s key sites across the US.

The Senior PBPK Advisor will support and execute assigned sections of the Catalent Science and Technology strategy for all regions (EU/USA/APAC), leveraging the internal scientific community and external collaborations to drive Catalent’s brand for innovation and advanced drug delivery technologies for small molecules.

Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures, and packages pharmaceutical and other products for customers around the world but principally in North America, Europe, and Asia Pacific. Among its core offerings, Catalent develops and manufactures oral and sterile pharmaceuticals in nearly all major dosage forms, and offers proprietary technologies used in many well-known prescriptions and over-the-counter products.

The Role:

  • Support Business Development (BD) efforts in the region for new and existing business opportunities in order to increase the conversion rate of new opportunities

  • For assigned projects, opportunities, and technologies, provide technical leadership and support to BD by helping to understand customer technical needs and by identifying and adapting the right Catalent solution/offering(s)

  • During preclinical phase, perform in-silico modelling to predict small molecule drug absorption in various animal species in order to select the most appropriate molecules to promote for evaluation as a drug, and to confirm that oral dosing is a viable route

  • Based on in-vitro and in-vivo data, perform in-silico modelling to estimate the rate and extent of absorption of drug molecules from 3 human dosing routes:

  • Oral

  • Pre-gastric

  • Inhalation

  • By applying absorption models, evaluate the effect of modified release on the rate and extent of absorption, in order to mitigate dose frequency, efficacy, and toxicity limitations

  • Perform modelling in specific patient populations (e.g. pediatric, geriatric, or special patient populations) upon request

  • Provide support to the Quotation Process to ensure the right scope is selected

  • Support an operating mechanism to provide visibility on opportunities in evaluation to PD and PM teams for proper capacity planning

  • Support the Optiform® Solution Suite offering and other offerings as requested

  • Other duties as assigned

The Candidate:

  • Bachelor’s Degree in the Life Sciences required; a degree in Pharmaceutics and/or a higher-level degree is a plus

  • 10+ years of experience in pharmaceutical industry is required

  • Thorough knowledge of the drug development process and industry regulations required

  • Experience with multiple customer segments, from small, venture capital backed entrepreneurs to big pharma is strongly preferred

  • Experience in multiple market segments (Rx, Consumer, Vitamins/Minerals/Supplements) and unit dosage forms, with strong background in solving complex biopharmaceutical challenges

  • Demonstrated R&D breadth with a technical background in Analytical, Formulation, Program Management, and an emphasis on feasibility and assessments of complex nature throughout the product life cycle

  • Strong knowledge in pharmaceutical sciences and biopharmaceutics

  • Immaculate presentation, collaboration, communication, and interpersonal skills with a strong ability to influence required

  • Thorough expertise in GastroPlus™ software is highly preferred

Why you should join Catalent:

  • High potential for career growth in an ever expanding team

  • Exposure to a global network of partners, colleagues, and clients

  • Opportunity to work with world-class subject matter experts, solve complex and diverse problems, and be the key driver to allow smaller companies to get medicines into patients faster

  • Individual accountability and managerial support to build PBPK models from scratch

  • Medical, dental, and vision insurance, as well as company matching 401K

  • 152 hours of Paid Time Off per year

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.

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 spam@catalent.com for us to investigate with local authorities.

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) .