Perrigo is a leading global healthcare supplier that develops, manufactures, markets and distributes over-the- counter (OTC) products, prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer healthcare products.
Post: Scientist (Pharmacokinetics)
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.
Job Specifications:
- Expertise in Pharmacokinetics / Bio-pharmaceutics or related field in an 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) guidelines on clinical studies and its conduct
- General 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.
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Required Skills
- PhD in Pharmacokinetics or Bio-pharmaceutics or relevant field with 0-3 years of industrial and / or academic research experience or MS in Pharmacokinetics or Bio-pharmaceutics or relevant field with more than 5 years of industrial experience.
- Highly motivated individual who is willing to learn and grow within a fast-paced organization, picking up skills and techniques during the process and applying them consistently in order to sustain and excel in an environment that believes in continuous improvement.
- Strong written / verbal communication skills, exhibits team player attributes, demonstrates sense of urgency and ownership.
- Hands on expertise in designing PK studies, reviewing bio-analytical information, analyzing PK data using WinNonLin® or equivalent, and basic knowledge of bio-statistics.
- General understanding of regulatory requirements for bioavailability and bioequivalence of pharmaceutical products.
Required Experience
PhD in Pharmacokinetics or Bio-pharmaceutics or relevant field with 0-3 years of industrial and / or academic research experience
OR
MS in Pharmacokinetics or Bio-pharmaceutics or relevant field with more than 5 years of industrial experience.
Additional Information:
Experience: 0-3 yrs
Tracking Code: 2012270
Location: Ambernath, Thane, Mumbai, India
Last Date: 24th August, 2014
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