Scientist (Pharmacokinetics) (2011753) at Piscataway

Job Description

Perrigo is the worlds largest manufacturer of over-the-counter pharmaceutical and nutritional products for the store brand and contract manufacturing markets and an emerging developer, manufacturer and marketer of prescription generic drugs.

Perrigo’s Global Scientific Affairs (GSA) group is involved in the research and development of generics dosage forms ranging from solid / liquid orals to dermatologicals to other niche product categories in order to provide quality affordable healthcare. The development of such dosage forms requires evaluation of bioequivalence (BE) to reference products. For our Bio-pharmaceutics group, we are seeking a highly motivated, qualified, research-oriented professional that could bring in expertise, resourcefulness, and creative approaches to support and further a diligent pharmacokinetic (PK) program. Reporting solid line to the Sr. Director of Product Development (USA), the job entails interacting with global Perrigo sites in designing pharmacokinetics studies, reviewing bio-analytical methods, evaluating data using bio-statistical tools, and complying with regulatory requirements in establishing bioequivalence and bio-availability of prescription (Rx) and consumer healthcare products (CHC).

Job Description:

Review summary basis of approval, prescribing information and other relevant literature on specific marketed products in order to prepare detailed summary reports in support of pharmacokinetic (PK) studies

Design PK studies for demonstrating bioequivalence (BE) for solid, liquid, topical and specialized dosage forms, including parenterals, ophthalmics, otics, nasal sprays, metered dose inhalers, and transdermal patches

Develop, review, and recommend scientifically-supported PK study BE protocols for ANDAs (and some NDA products)

Review bio-analytical method validation protocols and reports from CROs and ensure compliance with compendial and other regulatory requirements

Establish in-vitro in-vivo correlations by convoluting / deconvoluting PK data, using WinNonLin® or other equivalent applications

Conduct model dependent and model –independent analysis of dissolution or drug release data. Prior experience in analyzing data using statistical tools (SAS, JMP, etc.) is preferred.

Job Requirements

Expertise in Pharmacokinetics / Bio-pharmaceutics in academic research or generic pharmaceutical company or contract research organization

Hands-on experience in independently designing pharmacokinetic studies for ANDAs (and possibly NDA submissions), reviewing bio-analytical protocols / reports, analyzing pharmacokinetic data, and proposing PK strategies from a quality-by-design (QbD) perspective

Awareness of FDA (US, India) and EMEA guidelines on clinical studies and its conduct

Good understanding of statistical methodology required in clinical sciences

Demonstrated ability to work independently, manage and prioritize multiple projects, and perform concertedly in a team environment

Exhibits a sense of urgency, ownership, and drive. Demonstrates excellent interpersonal, written and verbal communication skills, and ability to prepare written reports / correspondence and presentations to senior leadership.

Ability to work closely with Product Development scientists (India, US, UK, Israel, and other Perrigo sites) by performing as one of the technical leads in bio-pharmaceutics. The incumbent will also act as an advisor in clinical drug development, CRO outsourcing, study monitoring, project management, and ensure that study conduct is in compliance with regulatory requirements. About 10% of business travel should be expected.

Experience Required

PhD in Pharmacokinetics or Bio-pharmaceutics with 0-3 years of industrial and / or academic research experience.

Country: USA, State: New Jersey, City: Piscataway, Company: Perrigo Company.