Principal Scientist, DMPK Advisory Services

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This is a full-time, fully remote , salaried position: Monday – Friday, 1st shift.

Our Somerset location is the corporate headquarters for Catalent Pharma Solutions. This location houses our state-of-the-art laboratory, clinical, commercial manufacturing plant for oral dose forms in addition to being the Center of Excellence for Highly Potent Active Pharmaceutical Ingredients (https://www.catalent.com/oral-dose/highly-potent-active-pharmaceutical-ingredients/) .

The Principal Scientist, Drug Metabolism & Pharmacokinetics (DMPK) Advisory Services , will lead and execute Pharmacokinetic modeling for the US region and support PK modeling for other regions, leveraging the internal scientific community and external collaborations to drive Catalent’s brand for drug delivery technologies.

The Principal Scientist, Drug Metabolism & Pharmacokinetics (DMPK) Advisory Services will interact with Scientific Advisory, Marketing, Business Development (BD), Customers, Business Units, and Product Development.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role:

• Perform in silico modeling to model drug absorption in various animal species in order to select most appropriate molecules to promote for evaluation as a drug, and to confirm viability of dosing route

• Based on in vitro and in vivo data, performs in silico modeling to estimate rate and extent of absorption of drug molecules from at least 3 human dosing routes

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

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

• Partner with Business Development in US region for new and existing business opportunities. For assigned projects or technologies

• Participate in the creation of Catalent Scientific Advisory strategy

• Participate in the creation and execution of Catalent scientific editorial line

• Support assigned Product Development efforts in the region

• Other duties as assigned

The Candidate:

• Bachelor’s Degree in Life Sciences, required

• Seven+ years of experience in pharmaceutical industry and five+ years of PBPK modelling, required

• Thorough expertise in Gastro plus and PBPK modeling

• Experience in biopharmaceutics and bioavailability enabling technologies, preferred

• Experience in multiple market segments (Rx) and unit dosage forms, with strong background in solving poor bioavailability issues and modified release

• Up to 15% travel expectations (globally)

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

T h e anticipated salary range for this position in Maryland is $150,000 - $175,000, plus bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why You Should Join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• 152 hours of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Positive working environment focusing on continually improving processes to remain innovative

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• Community engagement and green initiatives

• Generous 401K match

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• WellHub - program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .