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 live.This is a full-time 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
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 [email protected] . 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 [email protected] 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) .