Catalent
Principal Scientist, DMPK Advisory Services
Catalent, Baltimore, Maryland, United States, 21276
Principal Scientist, DMPK Advisory ServicesPosition Summary:Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.This is a full-time,
fully remote , salaried position: Monday – Friday, 1st shift.The Somerset location is the corporate headquarters for Catalent Pharma Solutions. This location houses our state-of-the-art laboratory, clinical, and commercial manufacturing plant for oral dose forms in addition to being the
Center of Excellence for 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 Role:Perform in silico modeling to model drug absorption in various animal species in order to select the most appropriate molecules to promote for evaluation as a drug, and to confirm the viability of the dosing route.Based on in vitro and in vivo data, perform in silico modeling to estimate the 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 the US region for new and existing business opportunities.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 the pharmaceutical industry and five+ years of PBPK modeling, 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 a strong background in solving poor bioavailability issues and modified release.Up to 15% travel expectations (globally).Individual may be required to sit, stand, and walk regularly and occasionally lift 0-15 pounds.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 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.
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fully remote , salaried position: Monday – Friday, 1st shift.The Somerset location is the corporate headquarters for Catalent Pharma Solutions. This location houses our state-of-the-art laboratory, clinical, and commercial manufacturing plant for oral dose forms in addition to being the
Center of Excellence for 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 Role:Perform in silico modeling to model drug absorption in various animal species in order to select the most appropriate molecules to promote for evaluation as a drug, and to confirm the viability of the dosing route.Based on in vitro and in vivo data, perform in silico modeling to estimate the 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 the US region for new and existing business opportunities.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 the pharmaceutical industry and five+ years of PBPK modeling, 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 a strong background in solving poor bioavailability issues and modified release.Up to 15% travel expectations (globally).Individual may be required to sit, stand, and walk regularly and occasionally lift 0-15 pounds.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 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.
#J-18808-Ljbffr